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临床试验/NCT05666167
NCT05666167
招募中
不适用

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

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 50 人2023年4月1日

概览

阶段
不适用
干预措施
Group Telehealth Exercise Sessions with text messaging plus booster sessions
疾病 / 适应症
Arthritis
发起方
VA Office of Research and Development
入组人数
50
试验地点
1
主要终点
Recruitment
状态
招募中
最后更新
24天前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2023年4月1日
结束日期
2027年3月31日
最后更新
24天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Exercise Initiation and Maintenance with Text Messaging and 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.

干预措施: Group Telehealth Exercise Sessions with text messaging plus booster sessions

Exercise Initiation and Maintenance with Text Messaging alone

Participants receive 3 months of group telehealth exercise initiation plus text messaging followed by 6 months of text messaging alone.

干预措施: Group Telehealth Exercise Sessions with text messaging plus booster sessions

结局指标

主要结局

Recruitment

时间窗: 3 months

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.

Number of sessions attended

时间窗: 3 months

The number of sessions attended as a percentage of the number offered will be gathered as a measure of feasibility and acceptability.

Number of Referrals

时间窗: 3 months

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.

次要结局

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

研究点 (1)

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