Choose to Move Replacement Ready: Implementation and Effectiveness 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
- 210
- 试验地点
- 2
- 主要终点
- Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components)
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 goals of this observational study are to describe how the adapted program, Choose to Move Replacement Ready (CTM-RR), is implemented in BC and determine if the adapted program improves health outcomes in people with hip and/or knee osteoarthritis who are on surgical waitlists for TKR/THR. The investigators will also evaluate whether any health benefits achieved by CTM-RR participants are maintained three months after they finish the program and also during the remaining time that they wait for their TKR/THR surgery.
The investigators will work with referral partners from hospitals and orthopaedic clinics in BC to recruit participants into CTM-RR. 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. Referral partners from hospitals and orthopaedic clinics in BC will inform patients about CTM-RR when they are booked for a hip or knee replacement surgery. Trained activity coaches hired by the Active Aging Society will deliver the online CTM-RR program to individuals on surgical waitlists for TKR/THR who register for the program. The investigators will then evaluate implementation of CTM-RR, impact of CTM-RR on participants' physical and social health, and maintenance of any health benefits.
The primary aim of this trial is to assess implementation and effectiveness of the adapted CTM-RR program. The specific objectives are to:
- assess implementation of CTM-RR. Specifically, implementation determinants (context, acceptability, feasibility, appropriateness, self-efficacy) and implementation outcomes (1° implementation outcome: fidelity; 2° implementation outcomes: reach, retention, adoption, dose, adaptation, satisfaction).
- evaluate effectiveness of CTM-RR. Specifically, whether CTM-RR increases participants' pre-operative moderate-to-vigorous physical activity (moderate to vigorous physical activity, 1° effectiveness outcome), mobility, psychosocial health, self-efficacy to manage their condition; improves their pain, function, quality of life, and perception of their joint condition, and decreases social isolation and loneliness (2° effectiveness outcomes).
- evaluate if participant health benefits (if any) are maintained 3 months after CTM-RR is completed.
- evaluate if participant health benefits (if any) are maintained up until participant's surgery (i.e. during the remaining surgical waiting period).
In partnership with the Active Aging Society, the investigators aim to deliver 20 CTM-RR online programs over two years to approximately 300 participants 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. The investigators expect approximately 70% of CTM-RR participants to volunteer for the evaluation.
The investigators will conduct a pre-post, observational cohort trial using a hybrid implementation effectiveness type 2 trial design. Data will be collected at 0 (baseline), 3 (postintervention), and 6 (long-term follow-up) months and 2-weeks before surgery (pre-operative) to assess implementation and impact of CTM-RR, and maintenance of any program-related benefits.
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
结局指标
主要结局
Implementation outcome: Fidelity (Proportion of participants who adhered to CTM-RR program components)
时间窗: 3 months
Obtained from post-program survey. Measures adherence to prescribed frequency, intensity, duration, and type of exercises performed, and attendance at CTM-RR group meetings.
Effectiveness outcome: Change in physical activity
时间窗: baseline, 3 and 6 months, 2 weeks pre-operative
Single-item physical activity questionnaire. Output measure is self-reported number of days engaging in ≥30 minutes of moderate-to-vigorous physical activity in the past week (range 0-7). Higher scores reflect a better outcome (i.e. increased physical activity)
次要结局
- Reach(3 months)
- Retention(Baseline, 3 and 6 months, 2 weeks pre-operative)
- Dose delivered(3 months)
- Adoption(3 months)
- Adaptation (survey)(3 months)
- Satisfaction with CTM-RR (survey)(3 months)
- Change in walking time(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in sedentary time(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in bone and muscle strengthening activity(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in balance activity(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in capacity for mobility(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in social isolation(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in loneliness(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in ability to participate in daily activities(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in Hip disability and Osteoarthritis Outcome 12-item Score(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in Knee disability and Osteoarthritis Outcome 12-item Score(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in patient global assessment of target joint(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in arthritis-specific self-efficacy(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in pain intensity(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in willingness to undergo surgery(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in anxiety(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in kinesiophobia(baseline, 3 and 6 months, 2 weeks pre-operative)
- Change in exercise self-efficacy(baseline, 3 and 6 months, 2 weeks pre-operative)
研究者
Heather McKay
Professor
University of British Columbia