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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

  • Education

    Other intervention

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

  • Health Status Updates

    Other intervention

    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 intervention

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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Multicomponent Telerehabilitation Intervention (Group 1)Experimental treatment 2 interventions
Group B: Education Control (Group 2)Other 3 interventions

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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

Time frame
Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
2

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 repetitions indicate better lower extremity strength.

Time frame
Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
3

Physical Activity

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

Time frame
Will be collected at Baseline, 12 weeks, and 24 weeks.
4

Exercise readiness to change

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).

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

Other outcomes

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