Expanding Exercise Programming for Veterans Through Telehealth

Study Overview
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Brief Summary
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The goal of this study is to evaluate the acceptability and feasibility of a group telehealth exercise program for Veterans with lower extremity osteoarthritis (OA). Methods: This is a randomized pilot trial where Veterans (n=50) receive a group telehealth exercise program (3 months), followed by an exercise maintenance phase (6 months) that includes either text messaging alone or text messaging plus group telehealth exercise booster sessions. The primary outcomes for this study are feasibility and acceptability of the intervention. Feasibility will be assessed through number and source of referrals, recruitment, and retention. Acceptability will be assessed through surveys and interviews for participants and providers addressing reasons for participation, satisfaction, perceived appropriateness, and overall experience containing Likert scales and both yes/no and open-ended questions. Exploratory outcomes, assessed at multiple time points during the course of the study, will measure changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and changes in performance measure and physical activity assessed remotely through individual telehealth sessions. Data will be collected at baseline, 3-, 6-, and 9-month follow-up.

Official Title
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Expanding Exercise Programming for Veterans Through Telehealth (CDA 22-066)

Conditions
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Arthritis

Intervention / Treatment
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* Behavioral: Group Telehealth Exercise Sessions with text messaging plus booster sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of symptomatic knee or hip OA Veterans at Eastern Colorado Healthcare System Primary Care Clinics with at least one VA visit within the past year physically inactive (add definition) Exclusion Criteria: No telephone access hip or knee surgery or acute meniscus or anterior cruciate ligament tear in the past six months recent hospitalization for cardiovascular/cerebrovascular event serious mental health condition or behavioral issues precluding participating in group exercise terminal illness motor neuron diseases severely impaired hearing, vision, or speech non-English speaking current participation in another OA or exercise intervention or lifestyle change study other self-reported or study team/primary care physician deemed health condition that would prohibit participation in the study no primary care physician visit in past 12 months pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Initiation and Maintenance with Text Messaging and Booster Sessions<br>Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions. | Behavioral: Group Telehealth Exercise Sessions with text messaging plus booster sessions<br>* Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.<br>|
| Active Comparator: Exercise Initiation and Maintenance with Text Messaging alone<br>Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone. | Behavioral: Group Telehealth Exercise Sessions with text messaging plus booster sessions<br>* Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging plus monthly group telehealth exercise booster sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Referrals | The number of referrals made by providers, through chart review, and the number of self-referrals by Veterans will be collected as a measure of feasibility. | 3 months | 
| Number of sessions attended | The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability. | 3 months | 
| Recruitment | The goal is that 50% of eligible provider and self-referrals and 25% of chart review referrals will participate in the program as a measure of success. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores | Changes in lower extremity pain (5 items), stiffness (2 items), and function (17 items) assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale scores. Each item is scored on a Likert scale ranging from 0 to 4 (none, mild, moderate, severe, and extreme). Scores range from 0-96 and higher scores are generally associated with worse outcomes. | Baseline, 3 months, 6 months, and 9 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, exercise maintenance, telehealth, group exercise, text messaging