MultimorbidityNCT04942613
Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach
A study testing Motivational Interviewing Techniques, Physical Therapy Interventions and Education in people with Multimorbidity and Physical Deconditioning, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multimorbidity, Physical Deconditioning
- What is being tested?
- Motivational Interviewing Techniques, Physical Therapy Interventions and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2021to 8 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age and older
- Multiple chronic conditions (Charlson Comorbidity Index 3)
- Impaired physical function (< or = 10 repetitions on 30 second sit to stand test)
Who cannot join
- Life expectancy < 12 months
- Acute or progressive neurological disorder (e.g. Amyotrophic Lateral Sclerosis, recent stroke)
- Moderate to severe dementia without caregiver assistance (< 18 on telephone Montreal Cognitive Assessment (MoCA Blind)
- Unstable medical condition precluding safe participation in progressive rehabilitation (e.g. unstable angina)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
About this study
Official title: Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability
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.
Read the detailed description
The aims of this study are to determine the feasibility and acceptability of the multicomponent telerehabilitation program and to preliminarily assess participant outcomes. The multicomponent program/intervention consists of 3 core components: 1) high-intensity rehabilitation interventions, 2) biobehavioral interventions, and 3) social support. The delivery of the program is supported by various technologies allowing for synchronous and asynchronous care and monitoring. Synchronous telerehabilitation will occur individually and in virtual groups. Feasibility and acceptability will be assessed by Veteran adherence to program components and validated surveys. Preliminary responsiveness will be assessed primarily by change in 7-day average step count and secondarily by other physical function tests and patient reported outcome measures. Study findings will have immediate clinical impact as they will guide implementation of safe and effective telerehabilitation strategies for medically complex older Veterans who lack access to standard in-person rehabilitation services.
- Conditions
- Multimorbidity, Physical Deconditioning
- Being tested
- Motivational Interviewing Techniques, Physical Therapy Interventions, Education, Qualitative Interview
- Keywords
- telerehabilitation, high intensity, biobehavioral, social support, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing TechniquesBehavioural
Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement.
Physical Therapy InterventionsOther
strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
EducationOther
Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
Qualitative InterviewOther
Qualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Telehealth Intervention (Group1) | Experimental | This group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. Receives: Behavioral: Motivational Interviewing Techniques; Other: Physical Therapy Interventions; Other: Qualitative Interview |
| Education (Group2) | Other | This group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention Receives: Other: Education; Other: Qualitative Interview |
| Research Participants | Other | Participants will be asked to complete up to 2 semi-structured interviews following completion of the 12-week multicomponent intervention. The first interview will occur within 3 weeks of program completion (by week 15 for Group 1 and by week 27 for Group 2). The second interview will occur between 3 to 6 months after the first interview. Receives: Other: Qualitative Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the Multicomponent Telehealth Intervention
Adherence will be calculated as the proportion of the number of sessions attended out of the number prescribed per protocol (32 sessions)
Measured: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Secondary outcomes (15)
Physical Activity
Physical activity will be measured via accelerometry and will include average 7-day step count
Measured: 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).
Feasibility of the Multicomponent Telehealth Intervention
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.
Measured: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Acceptability of the Multicomponent Telehealth Intervention
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."
Measured: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Participant Recruitment
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.
Measured: Baseline
Satisfaction of the Multicomponent Telehealth Intervention
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.
Measured: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Safety Event Count
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
Measured: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Exercise Stages of Change Questionnaire
Four-item questionnaire used to determine an individual's stage of change (pre-contemplation, contemplation, preparation, action, or maintenance)
Measured: Change from Baseline to 12 weeks
Self-efficacy for Exercise (SEE) Scale
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.
Measured: Change from Baseline to 12 weeks
30 Second Sit to Stand
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.
Measured: Change from Baseline to 12 weeks
Arm Curl Test
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)
Measured: Change from Baseline to 12 weeks
2-minute Step Test
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.
Measured: Change from Baseline to 12 weeks
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form
This questionnaire consists of 18 items rated on a 4-point Likert scale from 1 (unable) to 4 (none) to address the prompt: How much difficulty do you currently have. The total score is reported by summing each item; scores can range from 18 to 72. Higher scores indicate better mobility and less impairment/disability.
Measured: Change from Baseline to 12 weeks
3-Item Loneliness Scale
This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness.
Measured: Change from Baseline to 12 weeks
PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only
This is a patient reported outcome measure to assess physical health (subscale) and mental health (subscale). It is a 29-item questionnaire, and most items are rated on a 5-point Likert scale. There is 1 pain intensity item rated on a 0 (no pain) to 10 (worst pain imaginable) scale. PROMIS scores were transformed to a T-score where 50 represents the population mean, and the standard deviation is 10. The method reported by Hays et al. in 2018 was used to calculate the physical health and mental health subscales. Higher scores for subscales listed indicate better physical and mental health.
Measured: Change from Baseline to 12 weeks
Participant Retention
Participant retention will be tracked as part of feasibility and to inform a future trial. Retention will be reported as a proportion of the total number of participants who complete all outcome measure timepoints out of the total who complete baseline measures.
Measured: 12 Weeks and 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start22 Oct 2021
- Primary completion7 Aug 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized to 1 of 2 groups: Group1 will receive the intervention first for 12 weeks, and Group2 will receive the waitlist control for 12 weeks. At the end of 12 weeks, Group2 will crossover to the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer E. Stevens-Lapsley, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942613
- Sponsor's protocol ID
- E3730-P
- Other IDs
- 21-2773
- Status last verified
- Feb 2025
- First submitted
- 26 May 2021
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability
- ClinicalTrials.gov ID
- NCT04942613
- Acronym / sponsor ID
- E3730-P
- Conditions
- Multimorbidity, Physical Deconditioning
- Keywords
- telerehabilitation, high intensity, biobehavioral, social support, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Posted 7 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aims of this study are to determine the feasibility and acceptability of the multicomponent telerehabilitation program and to preliminarily assess participant outcomes. The multicomponent program/intervention consists of 3 core components: 1) high-intensity rehabilitation interventions, 2) biobehavioral interventions, and 3) social support. The delivery of the program is supported by various technologies allowing for synchronous and asynchronous care and monitoring. Synchronous telerehabilitation will occur individually and in virtual groups. Feasibility and acceptability will be assessed by Veteran adherence to program components and validated surveys. Preliminary responsiveness will be assessed primarily by change in 7-day average step count and secondarily by other physical function tests and patient reported outcome measures. Study findings will have immediate clinical impact as they will guide implementation of safe and effective telerehabilitation strategies for medically complex older Veterans who lack access to standard in-person rehabilitation services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized to 1 of 2 groups: Group1 will receive the intervention first for 12 weeks, and Group2 will receive the waitlist control for 12 weeks. At the end of 12 weeks, Group2 will crossover to the intervention.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Telehealth Intervention (Group1) | Experimental | Behavioral: Motivational Interviewing Techniques, Other: Physical Therapy Interventions, Other: Qualitative InterviewThis group will be randomized to receive the 12-week multicomponent intervention first. They will receive individual physical therapy sessions, group physical therapy sessions, and biobehavioral interventions emphasizing program engagement and increased daily physical activity. Most interventions will be provided synchronously through videoconferencing. Each participant will receive an individualized home exercise program. |
| Education (Group2) | Other | Other: Education, Other: Qualitative InterviewThis group will be randomized to 12-week waitlist control condition. They will receive a one-hour education session every 2 weeks (6 sessions total) on general health topics (e.g., basic nutrition, stress reduction, sleep hygiene). At the end of 12 weeks, they will transition to the 12-week multicomponent intervention |
| Research Participants | Other | Other: Qualitative InterviewParticipants will be asked to complete up to 2 semi-structured interviews following completion of the 12-week multicomponent intervention. The first interview will occur within 3 weeks of program completion (by week 15 for Group 1 and by week 27 for Group 2). The second interview will occur between 3 to 6 months after the first interview. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years of age and older
- Multiple chronic conditions (Charlson Comorbidity Index 3)
- Impaired physical function (< or = 10 repetitions on 30 second sit to stand test)
Key exclusion criteria (4 listed)
- Life expectancy < 12 months
- Acute or progressive neurological disorder (e.g. Amyotrophic Lateral Sclerosis, recent stroke)
- Moderate to severe dementia without caregiver assistance (< 18 on telephone Montreal Cognitive Assessment (MoCA Blind)
- Unstable medical condition precluding safe participation in progressive rehabilitation (e.g. unstable angina)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing TechniquesMotivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. | Behavioural | Multicomponent Telehealth Intervention (Group1) |
| Physical Therapy Interventionsstrengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise | Other | Multicomponent Telehealth Intervention (Group1) |
| EducationEducation on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene | Other | Education (Group2) |
| Qualitative InterviewQualitative interview to explore patient perspectives of the multicomponent telerehabilitation program (physical therapy, biobehavioral interventions, technology, and social support interventions) and how they contribute to program engagement and participation as well as changes in physical activity. | Other | Education (Group2), Multicomponent Telehealth Intervention (Group1), Research Participants |
Primary outcome
Adherence to the Multicomponent Telehealth Intervention
Time frame: 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)
15 secondary outcomes
Physical Activity
Time frame: 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).
Feasibility of the Multicomponent Telehealth Intervention
Time frame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Acceptability of the Multicomponent Telehealth Intervention
Time frame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Participant Recruitment
Time frame: Baseline
Satisfaction of the Multicomponent Telehealth Intervention
Time frame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Safety Event Count
Time frame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Exercise Stages of Change Questionnaire
Time frame: Change from Baseline to 12 weeks
Self-efficacy for Exercise (SEE) Scale
Time frame: Change from Baseline to 12 weeks
30 Second Sit to Stand
Time frame: Change from Baseline to 12 weeks
Arm Curl Test
Time frame: Change from Baseline to 12 weeks
2-minute Step Test
Time frame: Change from Baseline to 12 weeks
Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form
Time frame: Change from Baseline to 12 weeks
3-Item Loneliness Scale
Time frame: Change from Baseline to 12 weeks
PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only
Time frame: Change from Baseline to 12 weeks
Participant Retention
Time frame: 12 Weeks and 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer E. Stevens-Lapsley, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing Techniques, Physical Therapy Interventions and Education in people with Multimorbidity and Physical Deconditioning, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the Multicomponent Telehealth Intervention (time frame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.