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Trial Outcomes & Findings for A Community Wellness Program for Adults Living With Long-term Physical Disability (NCT NCT03653390)

NCT ID: NCT03653390

Last Updated: 2023-11-21

Results Overview

Change in perceived ability to participate in community activities from baseline to 6 months. Assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities short form (APSR). Higher scores indicate better ability to participate in social activities (total score range: 8-40)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

516 participants

Primary outcome timeframe

Change from baseline to 6 months

Results posted on

2023-11-21

Participant Flow

After enrollment and prior to group assignment, participants complete the baseline survey. Because participants have the option to withdraw at any time, some may choose to withdraw or are lost to follow up prior to randomization.

Participant milestones

Participant milestones
Measure
EnhanceWellness for Disability (EW-D)
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
Eight sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
Participant continues with their lives as they normally would.
Overall Study
STARTED
183
159
163
Overall Study
3 Month Survey
165
152
159
Overall Study
7 Month Survey
165
150
156
Overall Study
COMPLETED
163
150
155
Overall Study
NOT COMPLETED
20
9
8

Reasons for withdrawal

Reasons for withdrawal
Measure
EnhanceWellness for Disability (EW-D)
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
Eight sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
Participant continues with their lives as they normally would.
Overall Study
Lost to Follow-up
12
8
7
Overall Study
Withdrawal by Subject
6
1
1
Overall Study
Death
1
0
0
Overall Study
Paper Survey Lost
1
0
0

Baseline Characteristics

A Community Wellness Program for Adults Living With Long-term Physical Disability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
EnhanceWellness for Disability (EW-D)
n=183 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=159 Participants
Eight sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=163 Participants
Participant continues with their lives as they normally would.
Total
n=505 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Age, Categorical
Between 18 and 65 years
183 Participants
n=99 Participants
159 Participants
n=107 Participants
163 Participants
n=206 Participants
505 Participants
n=7 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Sex/Gender, Customized
Male
37 Participants
n=99 Participants
42 Participants
n=107 Participants
35 Participants
n=206 Participants
114 Participants
n=7 Participants
Sex/Gender, Customized
Female
145 Participants
n=99 Participants
117 Participants
n=107 Participants
127 Participants
n=206 Participants
389 Participants
n=7 Participants
Sex/Gender, Customized
Transgender
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Sex/Gender, Customized
Not Listed
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Sex/Gender, Customized
Prefer not to Answer
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
2 Participants
n=7 Participants
Race/Ethnicity, Customized
White / Caucasian
162 Participants
n=99 Participants
145 Participants
n=107 Participants
144 Participants
n=206 Participants
451 Participants
n=7 Participants
Race/Ethnicity, Customized
Black / African American
14 Participants
n=99 Participants
9 Participants
n=107 Participants
12 Participants
n=206 Participants
35 Participants
n=7 Participants
Race/Ethnicity, Customized
American Indian / Alaska Native
7 Participants
n=99 Participants
3 Participants
n=107 Participants
2 Participants
n=206 Participants
12 Participants
n=7 Participants
Race/Ethnicity, Customized
Asian / Asian American
4 Participants
n=99 Participants
3 Participants
n=107 Participants
4 Participants
n=206 Participants
11 Participants
n=7 Participants
Race/Ethnicity, Customized
Hawaiian Native / Pacific Islander
3 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
3 Participants
n=7 Participants
Race/Ethnicity, Customized
Other (Race)
3 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
9 Participants
n=7 Participants
Race/Ethnicity, Customized
Unknown
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race/Ethnicity, Customized
Prefer not to Answer (Race)
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
Race/Ethnicity, Customized
Hispanic
6 Participants
n=99 Participants
7 Participants
n=107 Participants
6 Participants
n=206 Participants
19 Participants
n=7 Participants
Race/Ethnicity, Customized
Not Hispanic
176 Participants
n=99 Participants
151 Participants
n=107 Participants
156 Participants
n=206 Participants
483 Participants
n=7 Participants
Race/Ethnicity, Customized
Other (Ethnicity)
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
2 Participants
n=7 Participants
Race/Ethnicity, Customized
Prefer not to Answer (Hispanic)
0 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
Region of Enrollment
United States
182 participants
n=99 Participants
158 participants
n=107 Participants
161 participants
n=206 Participants
501 participants
n=7 Participants
Region of Enrollment
Canada
1 participants
n=99 Participants
1 participants
n=107 Participants
2 participants
n=206 Participants
4 participants
n=7 Participants
PROMIS Ability to Participate in Social Roles & Activities v2.0 Short Form 8a
41.16 T-score
STANDARD_DEVIATION 7.79 • n=99 Participants
41.90 T-score
STANDARD_DEVIATION 6.39 • n=107 Participants
41.77 T-score
STANDARD_DEVIATION 7.36 • n=206 Participants
41.60 T-score
STANDARD_DEVIATION 7.22 • n=7 Participants

PRIMARY outcome

Timeframe: Change from baseline to 6 months

Population: All participants with a PROMIS APSR value at both baseline and 6 months were included in the analysis.

Change in perceived ability to participate in community activities from baseline to 6 months. Assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities short form (APSR). Higher scores indicate better ability to participate in social activities (total score range: 8-40)

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=161 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=148 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=154 Participants
Participant continues with their lives as they normally would.
Change in Self-reported Ability to Participate in Community Activities From Baseline to 6 Months
2.49 score on a scale
Standard Deviation 5.95
1.25 score on a scale
Standard Deviation 5.58
0.09 score on a scale
Standard Deviation 4.80

SECONDARY outcome

Timeframe: Change from baseline to 3 months

Population: All participants with a University of Washington Self-Efficacy Scale value at both baseline and 3 months were included in the analysis.

Change in confidence in managing chronic illness, measured via the University of Washington Self-Efficacy Scale. Higher score indicates better self-efficacy (total score range: 6-30)

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=165 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=153 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=159 Participants
Participant continues with their lives as they normally would.
Change in Self-report of Confidence in Managing One's Chronic Illness (Disease Management Self-efficacy) From Baseline to 3 Months
2.19 score on a scale
Standard Deviation 7.95
0.01 score on a scale
Standard Deviation 7.06
-0.07 score on a scale
Standard Deviation 6.16

SECONDARY outcome

Timeframe: Change from baseline to 3 months

Population: All participants with a PROMIS PI value at both baseline and 3 months were included in the analysis.

Change in self-report of interference due to pain from baseline to 3 months, assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) short form. Higher scores indicate more pain interference (total score range: 4-20)

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=165 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=153 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=159 Participants
Participant continues with their lives as they normally would.
Change in Self-reported Interference Due to Pain From Baseline to 3 Months
-1.22 score on a scale
Standard Deviation 6.47
-0.55 score on a scale
Standard Deviation 6.70
-0.23 score on a scale
Standard Deviation 6.66

SECONDARY outcome

Timeframe: Change from baseline to 3 months

Population: All participants with a PROMIS fatigue measure at baseline and 3 months.

Change in self-report of interference due to fatigue, from baseline to 3 months, assessed via the Patient-Reported Outcomes Measurement Information System Fatigue Interference short form. Higher scores indicate more fatigue interference (total score range: 4-20)

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=164 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=153 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=158 Participants
Participant continues with their lives as they normally would.
Change in Self-reported Interference Due to Fatigue From Baseline to 3 Months
-1.89 score on a scale
Standard Deviation 6.81
-1.09 score on a scale
Standard Deviation 6.85
-0.76 score on a scale
Standard Deviation 6.26

SECONDARY outcome

Timeframe: Change from baseline to 3 months

Population: All participants with a Connor-Davidson Resilience score at baseline and 3 months.

Change in self-report of psychological resilience, assessed via the Connor-Davidson Resilience Scale 10-item short form. Higher score indicates more resilience (total score range: 0-40)

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=164 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=150 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=157 Participants
Participant continues with their lives as they normally would.
Change in Psychological Resilience From Baseline to 3 Months
0.44 score on a scale
Standard Deviation 5.61
0.28 score on a scale
Standard Deviation 4.62
-0.77 score on a scale
Standard Deviation 4.20

SECONDARY outcome

Timeframe: Change from baseline to 12 months

Population: All participants with GPS data at baseline and 12 months.

Change in the average number of trips per day outside the home based on GPS data

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=40 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=47 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=50 Participants
Participant continues with their lives as they normally would.
Change in Number of Trips Outside the Home From Baseline to 12 Months
-0.25 trips per day outside the home
Standard Deviation 0.84
-0.12 trips per day outside the home
Standard Deviation 0.48
0.03 trips per day outside the home
Standard Deviation 0.83

SECONDARY outcome

Timeframe: Change from baseline to 12 months

Population: All participants with GPS data at baseline and 12 months.

Radius of Gyration refers to a metric of activity space or overall mobility distance, calculated by creating a shape representing the area of daily travel, with a central index point, based on GPS data.

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=44 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=50 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=51 Participants
Participant continues with their lives as they normally would.
Change in Radius of Gyration From Baseline to 12 Months
6328 meters
Standard Deviation 25527
6598 meters
Standard Deviation 105587
19917 meters
Standard Deviation 154597

SECONDARY outcome

Timeframe: Change from baseline to 12 months

Population: All participants with an average trips per day outside the home containing social elements measure at baseline and 12 months.

Change in the average number of trips per day outside the home containing "social" elements based on GPS and travel log data

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=37 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=42 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=44 Participants
Participant continues with their lives as they normally would.
Change in Number of Trips Outside the Home Containing "Social" Elements From Baseline to 12 Months
-0.18 social trips outside the home M per day
Standard Deviation 0.49
-0.10 social trips outside the home M per day
Standard Deviation 0.41
0.02 social trips outside the home M per day
Standard Deviation 0.72

SECONDARY outcome

Timeframe: Change from baseline to 12 months

Population: All participants with an average time per day spent in activities outside the home containing social elements measure at baseline and 12 months.

Change in average time per day spent in activities outside the home containing social elements from baseline to 12 months based on GPS and travel log data

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=37 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=43 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=46 Participants
Participant continues with their lives as they normally would.
Change in Time Spent in Activities Outside the Home Containing Social Elements From Baseline to 12 Months
-30.1 minutes
Standard Deviation 96.0
-58.8 minutes
Standard Deviation 145.2
36.5 minutes
Standard Deviation 127.9

SECONDARY outcome

Timeframe: Change from baseline to 12 months

Population: All participants with a PROMIS APSR value at both baseline and 12 months were included in the analysis.

Change in self-reported ability to participate in community activities from baseline to 12 months. Assessed via the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities short form (APSR). Higher scores indicate better ability to participate in social activities (total score range: 8-40)

Outcome measures

Outcome measures
Measure
EnhanceWellness for Disability (EW-D)
n=158 Participants
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=145 Participants
Eight 45-minute sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=153 Participants
Participant continues with their lives as they normally would.
Change in Self-reported Ability to Participate in Community Activities From Baseline to 12 Months
2.89 score on a scale
Standard Deviation 4.92
1.34 score on a scale
Standard Deviation 5.12
0.74 score on a scale
Standard Deviation 5.65

Adverse Events

EnhanceWellness for Disability (EW-D)

Serious events: 12 serious events
Other events: 45 other events
Deaths: 1 deaths

Wellness Education

Serious events: 13 serious events
Other events: 9 other events
Deaths: 0 deaths

Control

Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
EnhanceWellness for Disability (EW-D)
n=183 participants at risk
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=159 participants at risk
Eight sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=163 participants at risk
Participant continues with their lives as they normally would.
Injury, poisoning and procedural complications
Adverse Drug Reaction
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/159 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.61%
1/163 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Skin and subcutaneous tissue disorders
Cellulitis
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
1.3%
2/159 • Number of events 2 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Respiratory, thoracic and mediastinal disorders
COVID-19
1.1%
2/183 • Number of events 2 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.63%
1/159 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.61%
1/163 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Metabolism and nutrition disorders
Diabetic Ketoacidosis
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.63%
1/159 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Gastrointestinal disorders
Diarrhea
0.55%
1/183 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/159 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Injury, poisoning and procedural complications
Fall/Fall Related Injury
1.1%
2/183 • Number of events 2 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.63%
1/159 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Nervous system disorders
Multiple Sclerosis Relapse
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
1.3%
2/159 • Number of events 2 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Injury, poisoning and procedural complications
Post Surgical Complications
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
1.3%
2/159 • Number of events 2 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Skin and subcutaneous tissue disorders
Pressure Wound
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.63%
1/159 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
0.55%
1/183 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.63%
1/159 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Nervous system disorders
Spinal Cord Injury Complications
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.63%
1/159 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Blood and lymphatic system disorders
Sepsis
0.55%
1/183 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.63%
1/159 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Psychiatric disorders
Suicide Attempt
0.55%
1/183 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/159 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Gastrointestinal disorders
Throat Abscess
0.55%
1/183 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/159 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Surgical and medical procedures
Unknown Health Problem
0.00%
0/183 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/159 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.61%
1/163 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Renal and urinary disorders
Urinary Tract Infection
0.55%
1/183 • Number of events 1 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/159 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Infections and infestations
Wound Infection
1.1%
2/183 • Number of events 2 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/159 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).

Other adverse events

Other adverse events
Measure
EnhanceWellness for Disability (EW-D)
n=183 participants at risk
Up to 10 sessions of a telephone-based intervention delivered over a six-month period. EnhanceWellness for Disability (EW-D): Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
Wellness Education
n=159 participants at risk
Eight sessions of telephone-based wellness education delivered over a six-month period. Wellness Education: Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
Control
n=163 participants at risk
Participant continues with their lives as they normally would.
Injury, poisoning and procedural complications
Fall/Fall Related Injury
9.8%
18/183 • Number of events 23 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
2.5%
4/159 • Number of events 4 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Injury, poisoning and procedural complications
Other Injury
9.3%
17/183 • Number of events 19 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
1.9%
3/159 • Number of events 3 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
Nervous system disorders
Multiple Sclerosis Related Symptom or Relapse
5.5%
10/183 • Number of events 10 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
1.3%
2/159 • Number of events 2 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).
0.00%
0/163 • 1 year
Other Adverse Events collected through regular inquiry with participants including during baseline, 3 mo, 6 mo, and 12 mo survey as well as during telephone based sessions with interventionist for EW-D and CDC Education arms over 6 month treatment window. Number of events differs from number of participants due to some participants reporting the same adverse event (both term and organ system) during the course of the year long study (e.g. multiple falls from same participant).

Additional Information

Dr. Ivan Molton, PhD

University of Washington

Phone: 2065433602

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place