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NCT Number: NCT06288438

Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions

Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location status: Recruiting

Location contact

Jennifer E Stevens-Lapsley, PhD

CONTACT

[email protected]

303-949-9304

Jennifer E. Stevens-Lapsley, PhD

PRINCIPAL_INVESTIGATOR

About this study

The proposed MultiComponent TeleRehabilitation (MCTR) program addresses current healthcare deficiencies by using a multicomponent approach that includes both high-intensity rehabilitation interventions and self-management interventions that are not part of traditional physical therapy interventions. Therefore, the investigators propose a two-arm, parallel randomized trial using a crossover study design to determine the effectiveness (AIM 1) of a 12-week multicomponent telerehabilitation program to improve physical function. The investigators will also measure Veterans' clinical outcomes to evaluate the effectiveness of the MCTR program to improve physical activity, health self-management, and self-reported health (AIM 2). Lastly, the investigators will explore the effects of the MCTR program on safety events such as emergency room visits, hospitalizations, falls, and other adverse events (AIM 3). Participants (n=126) will be randomized to MCTR or Control group using computer-generated random blocks, stratified by sex. The MCTR group will participate in the 24-week program consisting of 1) progressive, high-intensity rehabilitation, 2) self-management interventions, 3) social support, and 4) technology supports. The 12-week program is split into three phases: the Active Phase (weeks 1-6), the Transition Phase (weeks 7-12), and the Sustainability Phase (weeks 13-24). The Control group will participate in education and health status update sessions in parallel to the MCTR 12-week program. Outcomes will be collected at baseline, 6 weeks, 12 weeks (primary endpoint), and 24 weeks. Achievement of the proposed aims will provide evidence to expand high quality telerehabilitation services for medically complex older Veterans with multiple factors contributing to poor health (e.g., social isolation, loneliness, physical inactivity, poor self-management). Importantly, results will guide the advancement of rehabilitation practices, moving away from a traditionally narrow, episodic, diagnosis-focused approach to a model emphasizing whole health self-management and sustained healthy living. Study findings will have immediate clinical impact as they will be directly translatable to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 years of age and older
  • Multiple chronic conditions (Functional Comorbidity Index > or = 3)
  • Impaired physical function (< or = 8 repetitions on 30 second sit to stand test)

Exclusion criteria

  • Life expectancy < 12 months
  • Acute or progressive neurological disorder (e.g. amyotrophic lateral sclerosis, recent stroke)
  • Moderate to severe dementia (<11 on telephone Montreal Cognitive Assessment(T-MoCA))
  • Medical conditions precluding safe participation in high-intensity rehabilitation (e.g. unstable angina)

Treatment and study plan

Motivational Interviewing Techniques

Behavioral

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 interventions

Other

Strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise.

Education

Other

Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc.

Health Status Updates

Other

Health Status Updates will be completed by a trained assessor. The assessor will ask about adverse events, general health topics, medication changes, and changes in social circumstances.

Physical Therapy Consult

Other

Participants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement.

Primary outcomes

  1. 2 Minute Step Test

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    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.

Secondary outcomes

  1. Arm Curl Test

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    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 a 8 pound weight and females use a 5 pound weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome)

  2. 30 Second Sit To Stand

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    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 repetitions indicate better lower extremity strength.

  3. Physical Activity

    Time frame: Will be collected at Baseline, 12 weeks, and 24 weeks.

    Physical activity will be measured via accelerometry and will include an averaged daily step count.

  4. Exercise readiness to change

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    Four-item survey collected via interview format, and it is used to categorize participants into stages of change according to the Transtheoretical Model, possible stages include: (pre-contemplating, contemplation, preparation, action, and maintenance).

  5. Self-efficacy for Exercise Scale

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    A 9-item survey, each item is scored on a scale of 0 (not confident) to 10 (very confident) and higher scores indicate greater self-efficacy.

  6. Self-efficacy of Managing Chronic Conditions

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    A 8-item survey rated on a 5-point Likert scale [I am not at all confident (1) to I am very confident (5)], and higher scored indicates better self-efficacy.

  7. The Patient-Specific Functional Scale

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    This is a questionnaire collected via interview format that quantifies activity or participation limitations that are important to the patient. Each participant identifies 3 activities that are important and that they are currently unable to do or having difficult performing due to their health; each item is then rated on a 0 (unable to preform activity) 0 to 10 (able to perform activity at the same level as before injury or problem) scale. The total score is an average of the 3 activities.

  8. Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    This questionnaire consists of 18 items rated on a 4-point Likert scale in response to the prompt, "How much difficulty do you currently have..." Total scores range from 18 to 72 and higher scores indicate less difficulty with physical tasks.

  9. Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    This is a 29-item questionnaire, and most items are rated on a 5-point Likert scale. There is one pain intensity item rated on a 0 (no pain) to 10 (worst pain imaginable) scale. Higher scores indicate more of the concept being measured.

  10. Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    An 8-item questionnaire rated on a 1 (never) to 5 (always) Likert scale. Higher scores indicate greater perceptions of loneliness and isolation, which is considered a worse outcome.

  11. Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    Includes 7 items rated on a 1 (not at all) to 5 (very much) Likert scale. Higher scores indicate greater satisfaction with discretionary social activities.

  12. Physical Activity and Social Support Scale

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    A 20 -item survey rated on a scale of 1 (never true) to 7 (always true) that measures emotional, informational, instrumental, validation, and companionship support related to physical activity. Higher scores indicated greater levels of perceived social support.

  13. Geriatric Pain Measure

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    Consists of 22 items scored as yes (1 point) or no (0 points) that assess whether or not a person does or would have pain during activities. There are also 2 items measured on a scale of 0 (no pain) to 10 (worst pain). Total scores range from 0-42 and adjusted scores range from 0-100 with higher scores indicating worse pain.

  14. Pain Coping Inventory

    Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.

    This measures both active (transformation, distraction, reducing demands) and passive (retreating, worrying, resting) coping strategies. The inventory includes 34 items rated on a scale from 1 (hardly ever) to 4 (very often). Higher scores indicate more frequent use of each specific coping strategy.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer E Stevens-Lapsley, PhD

CONTACT

[email protected]

(303) 949-9304

Maggie Givan, MA

CONTACT

[email protected]

(719) 251-7533

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Mar 1, 2024
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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