Clinical trial NCT04942613: Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach
Official title: Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Physical Deconditioning
Keywords: telerehabilitation
high intensity
biobehavioral
social support
physical activity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Adherence to the Multicomponent Telehealth Intervention
timeFrame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
Secondary outcomes:
measure: Physical Activity
timeFrame: 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).
measure: Feasibility of the Multicomponent Telehealth Intervention
timeFrame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
measure: Acceptability of the Multicomponent Telehealth Intervention
timeFrame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
measure: Participant Recruitment
timeFrame: Baseline
measure: Satisfaction of the Multicomponent Telehealth Intervention
timeFrame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
measure: Safety Event Count
timeFrame: Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2)
measure: Exercise Stages of Change Questionnaire
timeFrame: Change from Baseline to 12 weeks
measure: Self-efficacy for Exercise (SEE) Scale
timeFrame: Change from Baseline to 12 weeks
measure: 30 Second Sit to Stand
timeFrame: Change from Baseline to 12 weeks
measure: Arm Curl Test
timeFrame: Change from Baseline to 12 weeks
measure: 2-minute Step Test
timeFrame: Change from Baseline to 12 weeks
measure: Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form
timeFrame: Change from Baseline to 12 weeks
measure: 3-Item Loneliness Scale
timeFrame: Change from Baseline to 12 weeks
measure: PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only
timeFrame: Change from Baseline to 12 weeks
measure: Participant Retention
timeFrame: 12 Weeks and 24 Weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Jennifer E. Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References: