Expanding Exercise Programming for Veterans Through Telehealth

Official title

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

Overview

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.

Interventions

• Behavioral Group Telehealth Exercise Sessions with text messaging plus booster sessions
  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.

Primary outcome measures

• Number of Referrals [Time frame: 3 months]
• Number of sessions attended [Time frame: 3 months]
• Recruitment [Time frame: 3 months]

Secondary outcome measures (1)

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Scores [Time frame: Baseline, 3 months, 6 months, and 9 months.]

Eligibility criteria

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
• insufficient internet connectivity to participate in group telehealth

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Rocky Mountain Regional VA Medical Center, Aurora, CO — Aurora

Identifiers

NCT: NCT05666167 · CDX 22-008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗