Trial Outcomes & Findings for Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study) (NCT NCT04603482)
NCT ID: NCT04603482
Last Updated: 2025-05-13
Results Overview
14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
328 participants
Primary outcome timeframe
From T1 (baseline) to T2 (6 months) through T3 (one year)
Results posted on
2025-05-13
Participant Flow
Family carers of elders with dementia will be recruited using various strategies (community support organizations, publicly posted flyers, online ads) in NE Ohio. Eligible participants were adults over the age of 18, who were carers of a family member (over the age of 65) with a medical diagnosis of dementia, and had transitioned to a new phase of caring in the previous 6 months.
Enrolled participants may be excluded if they elect not to participate after enrolling.
Participant milestones
| Measure |
Need
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Overall Study
STARTED
|
105
|
100
|
103
|
|
Overall Study
COMPLETED
|
90
|
85
|
88
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
15
|
Reasons for withdrawal
| Measure |
Need
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
15
|
15
|
Baseline Characteristics
Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)
Baseline characteristics by cohort
| Measure |
Need
n=105 Participants
Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group were given a choice to participate in one of two self-management interventions (either biofeedback or resourcefulness training).
|
Preference
n=100 Participants
Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group were given a choice to participate in one of two self-management interventions (either biofeedback or resourcefulness training).
|
Attention Control
n=103 Participants
Participants in this arm were, at enrollment, caregivers (in the home), care partners (with a care facility), or caretakers (bereaved) of persons with dementia. Those in this randomly assigned group participated in diversional activities.
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
163 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
115 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
266 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
105 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
303 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
251 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=99 Participants
|
100 participants
n=107 Participants
|
103 participants
n=206 Participants
|
308 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From T1 (baseline) to T2 (6 months) through T3 (one year)Population: The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3.
14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress
Outcome measures
| Measure |
Need
n=90 Participants
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
n=85 Participants
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
n=88 Participants
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Change in Caregiver's Perceived Stress Scale
Baseline
|
19.73 score on a scale
Standard Deviation 7.97
|
21.01 score on a scale
Standard Deviation 6.37
|
19.84 score on a scale
Standard Deviation 7.48
|
|
Change in Caregiver's Perceived Stress Scale
T2 (6 months post baseline)
|
19.21 score on a scale
Standard Deviation 6.19
|
17.34 score on a scale
Standard Deviation 6.97
|
16.95 score on a scale
Standard Deviation 7.34
|
|
Change in Caregiver's Perceived Stress Scale
T3 (1 year post baseline)
|
16.49 score on a scale
Standard Deviation 6.55
|
18.40 score on a scale
Standard Deviation 7.41
|
17.19 score on a scale
Standard Deviation 7.54
|
PRIMARY outcome
Timeframe: From T1 (baseline) to T2 (6 months) through T3 (one year)Population: The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3
10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions.
Outcome measures
| Measure |
Need
n=90 Participants
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
n=85 Participants
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
n=88 Participants
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Change in Caregiver's Negative Emotions Checklist
Baseline
|
6.80 score on a scale
Standard Deviation 3.03
|
7.19 score on a scale
Standard Deviation 2.55
|
6.19 score on a scale
Standard Deviation 2.85
|
|
Change in Caregiver's Negative Emotions Checklist
T2 (6 months post baseline)
|
5.98 score on a scale
Standard Deviation 3.12
|
5.97 score on a scale
Standard Deviation 2.79
|
5.74 score on a scale
Standard Deviation 3.04
|
|
Change in Caregiver's Negative Emotions Checklist
T3 (1 year post baseline)
|
5.47 score on a scale
Standard Deviation 3.21
|
6.15 score on a scale
Standard Deviation 2.97
|
6.06 score on a scale
Standard Deviation 3.20
|
PRIMARY outcome
Timeframe: From T1 (baseline) to T2 (6 months) through T3 (one year)Population: The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3
8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition
Outcome measures
| Measure |
Need
n=90 Participants
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
n=85 Participants
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
n=88 Participants
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Change in Caregiver's Depressive Cognitions Scales
Baseline
|
8.48 score on a scale
Standard Deviation 6.36
|
10.22 score on a scale
Standard Deviation 6.93
|
8.74 score on a scale
Standard Deviation 7.09
|
|
Change in Caregiver's Depressive Cognitions Scales
T2 (6 months post baseline)
|
10.00 score on a scale
Standard Deviation 8.29
|
7.33 score on a scale
Standard Deviation 6.13
|
7.4 score on a scale
Standard Deviation 5.62
|
|
Change in Caregiver's Depressive Cognitions Scales
T3 (1 year post baseline)
|
8.11 score on a scale
Standard Deviation 6.78
|
8.96 score on a scale
Standard Deviation 7.80
|
8.03 score on a scale
Standard Deviation 5.96
|
PRIMARY outcome
Timeframe: From T1 (baseline) to T2 (6 months) through T3 (one year)Population: The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3
Change in self-assessment of general physical health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Outcome measures
| Measure |
Need
n=90 Participants
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
n=85 Participants
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
n=88 Participants
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)
Baseline
|
14.80 score on a scale
Standard Deviation 2.50
|
14.23 score on a scale
Standard Deviation 2.39
|
14.10 score on a scale
Standard Deviation 2.92
|
|
Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)
T2 (6 months post baseline)
|
14.29 score on a scale
Standard Deviation 4.94
|
14.67 score on a scale
Standard Deviation 2.61
|
14.68 score on a scale
Standard Deviation 2.77
|
|
Change in Global Health - Physical Health: PROMIS (Patient Reported Outcomes Measurement Information System)
T3 (1 year post baseline)
|
14.75 score on a scale
Standard Deviation 2.69
|
14.20 score on a scale
Standard Deviation 2.64
|
14.31 score on a scale
Standard Deviation 2.54
|
PRIMARY outcome
Timeframe: From T1 (baseline) to T2 (6 months) through T3 (one year)Population: All participants who completed the T3 questionnaire.
Change in self-assessment of general mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 0-20, and a higher score indicates better health and health-related quality of life.
Outcome measures
| Measure |
Need
n=90 Participants
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
n=85 Participants
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
n=88 Participants
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
Baseline
|
12.31 score on a scale
Standard Deviation 3.29
|
11.57 score on a scale
Standard Deviation 2.95
|
12.44 score on a scale
Standard Deviation 3.30
|
|
Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
T2 (6 months post baseline)
|
12.56 score on a scale
Standard Deviation 3.05
|
12.90 score on a scale
Standard Deviation 3.28
|
13.06 score on a scale
Standard Deviation 3.18
|
|
Change in Caregiver Global Health - Mental Health: PROMIS (Patient Reported Outcomes Measurement Information System)
T3 (1 year post baseline)
|
13.01 score on a scale
Standard Deviation 3.08
|
12.1 score on a scale
Standard Deviation 3.27
|
12.86 score on a scale
Standard Deviation 3.10
|
PRIMARY outcome
Timeframe: From T1 (baseline) to T2 (6 months) through T3 (one year)Population: The overall analyzed participants included all who completed the T3 questionnaire across the three arms. 15 participants in each arm discontinued their participation between baseline (T1) and T3. Thus, this number equals 308 (who completed baseline measures) minus 45 (who dropped out over time) which equals 263 at T3
Measure of Caregiving Health Risks: 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk
Outcome measures
| Measure |
Need
n=90 Participants
Participants will be assigned to either Resourcefulness Training or HRV-focused Biofeedback interventions based on their need (as determined by baseline data).
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Preference
n=85 Participants
Participants will be given a choice of Resourcefulness Training or HRV-focused Biofeedback interventions.
Resourcefulness Training: A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
Biofeedback Training: Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
|
Attention Control
n=88 Participants
Participants assigned to the attention control group will be presented with Diversionary activities.
Diversional Activites: An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
|
|---|---|---|---|
|
Change in Caregiver's Health Risk Behavior Scale
T2 (6 months post baseline)
|
15.89 score on a scale
Standard Deviation 3.09
|
15.54 score on a scale
Standard Deviation 3.80
|
15.10 score on a scale
Standard Deviation 3.12
|
|
Change in Caregiver's Health Risk Behavior Scale
Baseline
|
15.97 score on a scale
Standard Deviation 3.27
|
16.67 score on a scale
Standard Deviation 3.77
|
16.19 score on a scale
Standard Deviation 3.62
|
|
Change in Caregiver's Health Risk Behavior Scale
T3 (1 year post baseline)
|
15.24 score on a scale
Standard Deviation 3.10
|
15.45 score on a scale
Standard Deviation 3.52
|
15.17 score on a scale
Standard Deviation 3.34
|
Adverse Events
Need
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preference
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jaclene Zauszniewski, PhD
Case Western Reserve University
Phone: 216.368.3612
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place