NCT04942613

Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach

Completed NA Results posted Last updated 7 March 2025

What this trial tests

NA trial testing Motivational Interviewing Techniques in Multimorbidity in 50 participants. Completed in 8 September 2023.

Timeline

22 October 2021

Primary endpoint
7 August 2023

8 September 2023

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	22 October 2021
Primary completion	7 August 2023
Estimated completion	8 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interviewing Techniques
• Physical Therapy Interventions
• Education
• Qualitative Interview

Conditions studied

• Multimorbidity — all drugs for Multimorbidity →
• Physical Deconditioning — all drugs for Physical Deconditioning →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

60 and older, any sex, with Multimorbidity or Physical Deconditioning. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Adherence to the Multicomponent Telehealth Intervention Primary · Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions)

Group	Value	95% CI
All Participants	0.95	0.81 – 1.00

Physical Activity Secondary · Change from pre-program (baseline for Group 1, 12 weeks for Group 2) to post-program (12 weeks for Group 1, 24 weeks for Group 2).

Physical activity will be measured via accelerometry and will include average 7-day step count

Group	Value	95% CI
All Participants	-95	-514 – 915

Feasibility of the Multicomponent Telehealth Intervention Secondary · Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

Feasibility will be measured through a validated survey: Feasibility of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater feasibility of the program.

Group	Value	95% CI
All Participants	5.0	4.8 – 5.0

Acceptability of the Multicomponent Telehealth Intervention Secondary · Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

Acceptability will be measured through a validated survey: Acceptability of Intervention Measure consists of 4 items rated on a 5-point Likert scale (1) completely disagree to (5) completely agree. The average of the 4 items are reported. Higher scores indicate greater acceptability of the program."

Group	Value	95% CI
All Participants	5.0	4.7 – 5.0

Participant Recruitment Secondary · Baseline

Recruitment will be tracked as part of feasibility and to inform a future trial. Recruitment will be reported as a proportion of those enrolled out of the total number screened via phone screen.

Group	Value	95% CI
Recruitment	50

Satisfaction of the Multicomponent Telehealth Intervention Secondary · Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

Participation satisfaction with care provided via telerehabilitation will be assessed via the VA's approved survey: V-signals. It consists of 11 items rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree). The average of the 11 items are reported. Higher scores indicate better satisfaction.

Group	Value	95% CI
All Participants	4.9	4.6 – 5.0

Safety Event Count Secondary · Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)

The Safety Event Count is the cumulative number of study related (possibly, probably, or definitely) adverse events and severe adverse events counted from baseline to program end. Events will be categorized by type

Falls

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	2
Education (Group2)	1

ED Visit

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	3
Education (Group2)	1

Hospitalization

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	1
Education (Group2)	0

Other

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	1
Education (Group2)	3

Unrelated Falls

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	13
Education (Group2)	19

Unrelated ED Visits

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	7
Education (Group2)	10

Unrelated Hospitalizations

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	4
Education (Group2)	2

Unrelated Other

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	4
Education (Group2)	10

Exercise Stages of Change Questionnaire Secondary · Change from Baseline to 12 weeks

Four-item questionnaire used to determine an individual's stage of change (pre-contemplation, contemplation, preparation, action, or maintenance)

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1) Baseline	0
Multicomponent Telehealth Intervention (Group 1) 12 Weeks	0
Education (Group2) Baseline	1
Education (Group 2) 12 Weeks	1
Multicomponent Telehealth Intervention (Group1) Baseline	8
Multicomponent Telehealth Intervention (Group 1) 12 Weeks	3
Education (Group2) Baseline	12
Education (Group 2) 12 Weeks	11
Multicomponent Telehealth Intervention (Group1) Baseline	12
Multicomponent Telehealth Intervention (Group 1) 12 Weeks	3
Education (Group2) Baseline	6
Education (Group 2) 12 Weeks	6
Multicomponent Telehealth Intervention (Group1) Baseline	1
Multicomponent Telehealth Intervention (Group 1) 12 Weeks	8
Education (Group2) Baseline	2
Education (Group 2) 12 Weeks	2

Self-efficacy for Exercise (SEE) Scale Secondary · Change from Baseline to 12 weeks

Nine item questionnaire used to measure an individual's self-efficacy for exercising under different conditions. Each item is rated on a scale of 0 (not confident) to 10 (confident). The average of the 9 items is calculated; higher scores indicate better self-efficacy. The change from baseline to 12 weeks is calculated as 12 weeks minus baseline; thus, positive change scores indicate improvement in self-efficacy.

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	0.0	-2.8 – 1.0
Education (Group2)	0.0	-1.8 – 1.4

30 Second Sit to Stand Secondary · Change from Baseline to 12 weeks

The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function.

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	1.0	-1.0 – 4.0
Education (Group2)	1.0	0.0 – 2.0

Arm Curl Test Secondary · Change from Baseline to 12 weeks

This is a functional performance test for upper body strength and is performed on each arm (one arm at a time). It requires the participant to perform as many arm curls (biceps curls) as possible in 30 seconds. Males use an 8lb weight and females use a 5lb weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome)

Dominant

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	3.0	0.0 – 5.0
Education (Group2)	0.5	-1.5 – 4.0

Non-dominant

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	3.0	0.0 – 5.5
Education (Group2)	1	-0.5 – 3.5

2-minute Step Test Secondary · Change from Baseline to 12 weeks

This is a functional performance test for aerobic endurance. It requires participants to march in place for 2 minutes (alternating legs), and the score is the number of repetitions completed on the right leg. Scores are continuous, and higher scores indicate better aerobic endurance.

Group	Value	95% CI
Multicomponent Telehealth Intervention (Group1)	15.0	7.0 – 31.0
Education (Group2)	0.0	-5.0 – 15.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Multicomponent Telehealth Intervention (Group1) During and Related to Intervention

Serious: 0/25 (0%)

Deaths: 0/25

Education (Group 2) During and Related to Multicomponent Telehealth Intervention

Serious: 0/25 (0%)

Deaths: 0/25

Multicomponent Telehealth Intervention (Group 1) Not During and Not Related to Intervention

Serious: 0/25 (0%)

Deaths: 1/25

Education (Group 2) Not During and Not Related to Intervention

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (4 terms — click to expand)

Reaction	System	Multicomponent Telehealth …	Education (Group 2) During…	Multicomponent Telehealth …	Education (Group 2) Not Du…
Fall	General disorders	—	—	—	—
Cardiac	Cardiac disorders	—	—	—	—
Musculoskeletal	Musculoskeletal and connective tissue disorders	—	—	—	—
Respiratory Infection	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04942613 adverse events section.

Sponsor's own description

The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older Veterans and to preliminarily assess participant outcomes (physical activity, physical function, quality of life, loneliness) to the program.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multicomponent telerehabilitation program for veterans with multimorbidity: A randomized controlled feasibility study.
   Rauzi MR, Abbate LM, Churchill L, Garbin AJ, et al · · 2025 · cited 1× · PMID 39777862 · DOI 10.1002/pmrj.13299