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Clinical Trials/NCT04942613
NCT04942613
Completed
N/A

Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach: A Pilot Study of Feasibly and Acceptability

VA Office of Research and Development1 site in 1 country50 target enrollmentOctober 22, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multimorbidity
Sponsor
VA Office of Research and Development
Enrollment
50
Locations
1
Primary Endpoint
Adherence to the Multicomponent Telehealth Intervention
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2021
End Date
September 8, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Physical Activity(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(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
  • Acceptability of the Multicomponent Telehealth Intervention(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
  • Participant Recruitment(Baseline)
  • Satisfaction of the Multicomponent Telehealth Intervention(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
  • Safety Event Count(Program end- 12 weeks in Intervention group (Group1); 24 weeks in Waitlist control (Group2))
  • Exercise Stages of Change Questionnaire(Change from Baseline to 12 weeks)
  • Self-efficacy for Exercise (SEE) Scale(Change from Baseline to 12 weeks)
  • 30 Second Sit to Stand(Change from Baseline to 12 weeks)
  • Arm Curl Test(Change from Baseline to 12 weeks)
  • 2-minute Step Test(Change from Baseline to 12 weeks)
  • Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Outpatient Routine Short Form(Change from Baseline to 12 weeks)
  • 3-Item Loneliness Scale(Change from Baseline to 12 weeks)
  • PROMIS-29+2 Profile v2.1 Physical Health and Mental Health Subscales Only(Change from Baseline to 12 weeks)
  • Participant Retention(12 Weeks and 24 Weeks)

Study Sites (1)

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