Trial Outcomes & Findings for Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology (NCT NCT05379504)

NCT ID: NCT05379504

Last Updated: 2026-07-24

Results Overview

The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, assesses functional status as a measurement of the client's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. This scale ranges from 0 to 6. This measure is the calculated change in score from baseline to post-intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

1 year

Results posted on

2026-07-24

Participant Flow

Study participants were recruited using passive methods (flyers distributed to local healthcare clinics, radio ads, print ads, snowball sampling) and active methods (Honest Broker service through MU Healthcare electronic health records for those matching inclusion criteria). No stakeholders were recruited for active participation in this study. Participants were randomized in blocks of 4 to either the Self Management Arm or the Health Education Arm. Stakeholders were not enrolled in this study.

No differences between enrollment and study arm assignment

Participant milestones

Participant milestones
Measure
Self Management
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Overall Study
STARTED
25
33
Overall Study
COMPLETED
25
27
Overall Study
NOT COMPLETED
0
6

Reasons for withdrawal

Reasons for withdrawal
Measure
Self Management
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Overall Study
Death
0
1
Overall Study
Adverse Event
0
1
Overall Study
Withdrawal by Subject
0
3
Overall Study
Physician Decision
0
1

Baseline Characteristics

Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Self Management
n=25 Participants
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=32 Participants
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Total
n=57 Participants
Total of all reporting groups
Sex: Female, Male
Female
17 Participants
n=9 Participants
19 Participants
n=27 Participants
36 Participants
n=267 Participants
Age, Continuous
76.4 years
STANDARD_DEVIATION 5.8 • n=9 Participants
74.6 years
STANDARD_DEVIATION 5.3 • n=27 Participants
75.7 years
STANDARD_DEVIATION 5.7 • n=267 Participants
Sex: Female, Male
Male
8 Participants
n=9 Participants
13 Participants
n=27 Participants
21 Participants
n=267 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Asian
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
White
24 Participants
n=9 Participants
32 Participants
n=27 Participants
56 Participants
n=267 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=9 Participants
32 Participants
n=27 Participants
57 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Lawton IADL Measure
7.44 Score on Scale
STANDARD_DEVIATION 1.12 • n=9 Participants
7.41 Score on Scale
STANDARD_DEVIATION 1.54 • n=27 Participants
7.43 Score on Scale
STANDARD_DEVIATION 1.39 • n=267 Participants
Katz Index of Independence in Activities of Daily Living
5.56 Score on Scale
STANDARD_DEVIATION 0.58 • n=9 Participants
5.56 Score on Scale
STANDARD_DEVIATION 1.15 • n=27 Participants
5.56 Score on Scale
STANDARD_DEVIATION 0.95 • n=267 Participants
PROMIS-43 Profile (v2.1)
Ability to Participate in Social Roles
47.62 T-score
STANDARD_DEVIATION 10.02 • n=9 Participants
50.56 T-score
STANDARD_DEVIATION 7.29 • n=27 Participants
49.15 T-score
STANDARD_DEVIATION 8.75 • n=267 Participants
PROMIS-43 Profile (v2.1)
Anxiety/Fear
50.84 T-score
STANDARD_DEVIATION 7.52 • n=9 Participants
50.60 T-score
STANDARD_DEVIATION 7.18 • n=27 Participants
50.72 T-score
STANDARD_DEVIATION 7.27 • n=267 Participants
PROMIS-43 Profile (v2.1)
Depression/Sadness
49.63 T-score
STANDARD_DEVIATION 7.52 • n=9 Participants
49.77 T-score
STANDARD_DEVIATION 6.77 • n=27 Participants
49.70 T-score
STANDARD_DEVIATION 7.07 • n=267 Participants
PROMIS-43 Profile (v2.1)
Fatigue
53.70 T-score
STANDARD_DEVIATION 11.07 • n=9 Participants
52.32 T-score
STANDARD_DEVIATION 5.17 • n=27 Participants
52.99 T-score
STANDARD_DEVIATION 8.48 • n=267 Participants
PROMIS-43 Profile (v2.1)
Pain Interference
54.66 T-score
STANDARD_DEVIATION 10.18 • n=9 Participants
55.86 T-score
STANDARD_DEVIATION 7.09 • n=27 Participants
55.28 T-score
STANDARD_DEVIATION 8.65 • n=267 Participants
PROMIS-43 Profile (v2.1)
Physical Function
38.12 T-score
STANDARD_DEVIATION 6.29 • n=9 Participants
40.49 T-score
STANDARD_DEVIATION 8.56 • n=27 Participants
39.35 T-score
STANDARD_DEVIATION 7.57 • n=267 Participants
PROMIS-43 Profile (v2.1)
Sleep Disturbance
48.26 T-score
STANDARD_DEVIATION 7.70 • n=9 Participants
47.07 T-score
STANDARD_DEVIATION 8.49 • n=27 Participants
47.64 T-score
STANDARD_DEVIATION 8.06 • n=267 Participants
PROMIS-43 Profile (v2.1)
Global Pain
2.88 T-score
STANDARD_DEVIATION 1.99 • n=9 Participants
3.59 T-score
STANDARD_DEVIATION 2.18 • n=27 Participants
3.12 T-score
STANDARD_DEVIATION 2.05 • n=267 Participants

PRIMARY outcome

Timeframe: 1 year

The Katz Index of Independence in Activities of Daily Living, commonly referred to as the Katz ADL, assesses functional status as a measurement of the client's ability to perform activities of daily living independently. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. This scale ranges from 0 to 6. This measure is the calculated change in score from baseline to post-intervention.

Outcome measures

Outcome measures
Measure
Self Management
n=25 Participants
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=27 Participants
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Change in Katz ADL Index
0.32 Change in score
Standard Deviation 0.01
0.22 Change in score
Standard Deviation 0.02

PRIMARY outcome

Timeframe: 1 year

PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. The PROMIS-43 is a collection of 6-item short forms assessing anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities as well as a single pain intensity item. Each short form is scored as a T-score, with a score of 50 being average. This scale is 0 to 100. Higher scores indicate more (anxiety, depression, etc) and lower scores indicate less. This measure is the change in the T-score from baseline to post-intervention. A positive change in T-score is different for each sub-domain. Each will be indicated below in the row title.

Outcome measures

Outcome measures
Measure
Self Management
n=25 Participants
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=27 Participants
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Change in PROMIS-43
Ability to participate in social roles (positive is better)
1.74 Change in score
Standard Deviation 0.01
-1.79 Change in score
Standard Deviation 0.01
Change in PROMIS-43
Anxiety (negative is better)
-1.61 Change in score
Standard Deviation 0.01
-3.36 Change in score
Standard Deviation 0.02
Change in PROMIS-43
Depression (negative is better)
-0.32 Change in score
Standard Deviation 0.01
-0.57 Change in score
Standard Deviation 0.01
Change in PROMIS-43
Fatigue (negative is better)
-0.96 Change in score
Standard Deviation 0.01
1.44 Change in score
Standard Deviation 0.01
Change in PROMIS-43
Pain Interference (negative is better)
-0.20 Change in score
Standard Deviation 0.01
0.23 Change in score
Standard Deviation 0.01
Change in PROMIS-43
Physical Function (positive is better)
1.16 Change in score
Standard Deviation 0.01
-0.44 Change in score
Standard Deviation 0.01
Change in PROMIS-43
Sleep Disturbance (negative is better)
-0.95 Change in score
Standard Deviation 0.01
-0.53 Change in score
Standard Deviation 0.02
Change in PROMIS-43
Global Pain (negative is better)
0.40 Change in score
Standard Deviation 0.01
0.19 Change in score
Standard Deviation 0.01

SECONDARY outcome

Timeframe: 1 year

The Hospital Anxiety and Depression Scale is a two dimension scale developed to identify depression and anxiety. There are 14 items. The respondent rates each item on a 4 point scale ranging from 0 (absence) to 3 (extreme presence). Some questions are inversely scored. This outcome was assessed at baseline and post-intervention. This measure is the change in score on the scale. The overall range of scores is 0 to 42. Anxiety and depression domains are reported separately below.

Outcome measures

Outcome measures
Measure
Self Management
n=25 Participants
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=27 Participants
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Change in Hospital Anxiety and Depression Scale
Anxiety
-0.40 Change in score on scale
Standard Deviation 0.01
0.52 Change in score on scale
Standard Deviation 0.01
Change in Hospital Anxiety and Depression Scale
Depression
-0.32 Change in score on scale
Standard Deviation 0.02
0.19 Change in score on scale
Standard Deviation 0.01

SECONDARY outcome

Timeframe: 1 year

The COPM is administered by an occupational therapy practitioner. The participant ranks their five most important occupations that they currently have difficulty with. Then they rate their current performance and satisfaction with that performance on a scale of 1-10. The score on those five occupations are averaged to get a score of self-rated occupational performance and self-rated satisfaction with performance. The scores on both scales can range from 0 to 10. This measure is the change from baseline to post-intervention on both scores, reported separately below.

Outcome measures

Outcome measures
Measure
Self Management
n=25 Participants
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=27 Participants
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Change in Canadian Occupational Performance Measure
Self-rated occupational performance
1.96 Change in score on scale
Standard Deviation 0.03
1.64 Change in score on scale
Standard Deviation 0.04
Change in Canadian Occupational Performance Measure
Self-rated satisfaction with occupational performance
2.26 Change in score on scale
Standard Deviation 0.3
2.40 Change in score on scale
Standard Deviation 0.5

SECONDARY outcome

Timeframe: 1 year

The Patient Activation Measure® is a 13-item survey that assesses an individual's knowledge, skills and confidence integral to managing one's own health and healthcare. The participants rates how much they agree or disagree (1-4 scale) with 13 statements. Using a licensed tool, a score ranging 0-100 is calculated. This measure is the change in that score from baseline to post-intervention. A positive change score means improvement.

Outcome measures

Outcome measures
Measure
Self Management
n=25 Participants
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=27 Participants
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Change in Patient Activation Measure
1.83 Change in score on scale
Standard Deviation 0.3
9.35 Change in score on scale
Standard Deviation 1.15

Adverse Events

Self Management

Serious events: 6 serious events
Other events: 19 other events
Deaths: 0 deaths

Health Education

Serious events: 6 serious events
Other events: 29 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Self Management
n=25 participants at risk
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=33 participants at risk
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
General disorders
Hospitalization
20.0%
5/25 • From enrollment until post-intervention data collection (1 year)
18.2%
6/33 • From enrollment until post-intervention data collection (1 year)
General disorders
Rehabilitation stay
4.0%
1/25 • From enrollment until post-intervention data collection (1 year)
0.00%
0/33 • From enrollment until post-intervention data collection (1 year)

Other adverse events

Other adverse events
Measure
Self Management
n=25 participants at risk
The 5A's Behavior Change Mode \[39\] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Health Education
n=33 participants at risk
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
General disorders
Non-serious adverse event
76.0%
19/25 • From enrollment until post-intervention data collection (1 year)
87.9%
29/33 • From enrollment until post-intervention data collection (1 year)

Additional Information

Rachel Wolpert, OTD, OTR/L, FAOTA, FACRM

University of Missouri

Phone: 573-884-2418

Results disclosure agreements

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