Choose to Move Replacement Ready: A Feasibility Trial of a Virtual Health-promoting Intervention for People Awaiting Total Hip or Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Implementation Outcome: Recruitment
研究概览
简要总结
Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. Recently, the investigators adapted CTM for the >14000 people in BC who are on surgical waitlists for total knee replacement or total hip replacement (TKR/THR) for osteoarthritis (OA). The primary goal of this observational study is to learn if the adapted program, Choose to Move Replacement Ready (CTM-RR), is feasible to deliver to people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR.
Participants who enrol in CTM-RR will answer online survey questions about the program and about their physical activity, mobility, pain, function, quality of life, willingness to undergo surgery, overall perception of their joint condition, psychosocial health, self-efficacy, social isolation, loneliness, and sedentary time. CTM-RR activity coaches will also answer online survey questions about the program. CTM-RR participants, activity coaches, and referral partners will also participate in interviews about the program.
详细描述
Choose to Move (CTM) an effective 3-month, choice-based health-promoting program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. Choose to Move Replacement Ready (CTM-RR) is an adapted version of the program tailored to support individuals with hip and/or knee osteoarthritis on surgical waitlists for TKR/THR, with the overall goal of enhancing key health outcomes. Trained activity coaches hired by the Active Aging Society will deliver CTM-RR to individuals on surgical waitlists for TKR/THR. The investigators will then evaluate implementation of CTM-RR, and the impact of CTM-RR on participants' physical and social health.
The primary objective of this trial is to:
- Assess implementation outcomes (participant recruitment, retention, dose delivered/received, fidelity) of the adapted CTM model against predetermined feasibility targets.
The secondary objectives are to: 2. Describe implementation determinants (acceptability, feasibility, appropriateness) and outcomes (reach, adaptations, perceived participant responsiveness, adoption) of the adapted CTM model. 3. Evaluate the preliminary estimates of effectiveness of CTM-RR. Specifically, whether CTM-RR increases participants' pre-operative moderate-to-vigorous physical activity, light physical activity, mobility, psychosocial health, and self-efficacy to manage their condition; improves their perception of their joint condition, function, and quality of life; and decreases pain, social isolation, loneliness, and sedentary time 4. Assess whether participant-level health benefits, if any, are maintained 3 months after participants complete the CTM-RR program.
In partnership with the Active Aging Society, the investigators aim to deliver 6 CTM-RR online programs over 9-months to approximately 60 participants total across BC. There is no cost to participate in the CTM-RR program, and individuals may participate in CTM-RR regardless of whether they choose to be evaluated as part of this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Activity coach hired by the Active Aging Society (activity coaches must speak English to participate in the evaluation);
- •English-speaking older adults (aged >=50 years) who participate in CTM-RR will be invited to participate in the evaluation
- •Referral partner (People who work in a healthcare setting who refer patients into the program)
排除标准
- •non-English speaking activity coach
- •non-English speaking referral partner
研究组 & 干预措施
Choose to Move Replacement Ready
CTM-RR is a 3-month program for individuals with hip and/or knee osteoarthritis on surgical waitlists for total hip or total knee replacement that includes three required components: 1) a 30-min one-on-one virtual consultation (via Zoom) where activity coaches support participants to set goals and develop a PA action plan; 2) 8 virtual group meetings (via Zoom, 90-min each) facilitated by activity coaches, with small groups of participants (10/program) who provide peer support. Each meeting includes: i) two, 15-min movement breaks where participants perform structured hip and knee exercises delivered by the coach and ii) education and discussion on relevant topics (e.g. goal setting, PA, what to expect from surgery); 3) Home-based hip and knee exercises to complete independently, 2x/week. Optional components of CTM-RR include 4) a bi-weekly newsletter distributed by the AAS and 5) peer support check-ins outside of group meetings.
干预措施: Choose to Move Replacement Ready (Behavioral)
结局指标
主要结局
Implementation Outcome: Recruitment
时间窗: baseline
Obtained from program records. Proportion of people who attend the program information session, are eligible, and enrol in the program. Feasibility Target: Enrol 50% of people attending the program information session who are eligible to participate to the program.
Implementation Outcome: Dose delivered
时间窗: 3 months
Obtained from post-program survey. Proportion of required intervention components (group meetings and one-on-one consultations) delivered by activity coaches. Feasibility target: Activity coaches delivering 90% of required intervention components (group meetings and one-on-one consultations).
Implementation Outcome: Dose received
时间窗: 3 months
Obtained from post-program survey. Proportion of participants who consent to the evaluation, attending required intervention components (group meetings and one-on-one consultation) Feasibility target: Participants who consent to the evaluation attending 6 out of 9 (\>60%) of required intervention components (group meetings and one-on-one consultation)
Implementation Outcome: Fidelity (Proportion of participants who adhered to prescribed exercise)
时间窗: 3 months
Obtained from post-program survey. Measures adherence to prescribed frequency, intensity, duration, and type of exercises performed. 80% of participants adhered to all of the following criteria: * on average, frequency= two sessions per week or greater * on average, intensity= 7 out of 10 rating of perceived exertion or greater * on average, duration= 20 minutes or greater * on average, exercises were completed as prescribed without omission or substitution of prescribed exercises
Adverse events: Number of adverse events
时间窗: 3 months
Obtained from post-program survey. Number of adverse events related to Choose to Move: Replacement Ready that required medical treatment and/or lasted two or more days.
Implementation Outcome: Retention
时间窗: baseline, 3, 6 months
Obtained from evaluation records. Proportion of participants who consent to the evaluation who complete each follow-up assessment. Feasibility target: A minimum of 80% of participants who consented to the evaluation (and are in the pre-operative period) completing each follow-up assessment.
次要结局
- Change in physical activity(baseline, 3, 6 months)
- Change in walking time(baseline, 3, 6 months)
- Change in sedentary time(baseline, 3, 6 months)
- Change in bone and muscle strengthening activity(baseline, 3, 6 months)
- Change in balance activity(baseline, 3, 6 months)
- Change in capacity for mobility(baseline, 3, 6 months)
- Change in social isolation(baseline, 3, 6 months)
- Change in loneliness(baseline, 3, 6 months)
- Change in ability to participate in daily activities(baseline, 3, 6 months)
- Change in Hip disability and Osteoarthritis Outcome 12-item Score(baseline, 3, 6 months)
- Change in Knee disability and Osteoarthritis Outcome 12-item Score(baseline, 3, 6 months)
- Change in patient global assessment of target joint(baseline, 3, 6 months)
- Change in arthritis-specific self-efficacy(baseline, 3, 6 months)
- Change in pain intensity(baseline, 3, 6 months)
- Change in willingness to undergo surgery(baseline, 3, 6 months)
- Change in anxiety(baseline, 3, 6 months)
- Change in kinesiophobia(baseline, 3, 6 months)
研究者
Heather McKay
Professor
University of British Columbia