Adapting REhabilitation Delivery for Maximum Impact at Home
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in Patient Activation Measure from baseline to post intervention and 6-months and 12-months
研究概览
简要总结
Hip and knee osteoarthritis (OA) is a burden of disability in adults, with many seeking total joint arthroplasty (TJA) to reduce their symptoms. Almost 50% of people screened for TJA are referred for further rehabilitation rather than TJA. However, access to community-based rehabilitation is limited for those living in rural settings. Recent advances in tele-rehabilitation using smart phone technology, widely available in rural areas, provides a means to access rehabilitation from home.
ReDI@Home will examine the impact of home-based e-Rehabilitation, delivered via smart phone, for rural residents living with moderate to advanced OA. This randomized feasibility trial will compare 2 e-Rehabilitation programs (eRP) of varying intensity (eRP-LOw Intensity [eRP-LO] and eRP-HIgh Intensity [eRP- HI]).
The investigators think that the eRP are feasible and that both eRP will improve OA self-management. However, eRP-HI will improve patient outcomes more than eRP-LO.
详细描述
ReDI@Home is a randomized feasibility trial that will evaluate implementation of home-based interventions to assist persons with moderate to advanced hip or knee osteoarthritis (OA) living in rural environments with self-management. Although others have used similar web-based interventions for urban patients living with inflammatory arthritis, our selected group of rural residents living with OA, has been under-served with these types of interventions, often due to internet service limitations. Following this feasibility work, a definitive randomized trial of the refined rehabilitation programs relative to usual OA care in rural settings is planned. This feasibility trial is essential before a definitive trial.
Once ReDI@Home is refined and tested, the intervention will be transferable to other provinces/settings where rural residents require rehabilitation. This approach may also work for older adults living in urban areas, whose community rehabilitation access may be limited due to physical distancing associated with COVID-19.
Objectives and Hypotheses
ReDI@Home will examine the impact of home-based e-Rehabilitation, delivered using smart phone technology, for those living with moderate to advanced OA who reside in rural regions. This randomized feasibility trial will compare 2 e-Rehabilitation Programs (eRP):
eRP-LOw Intensity (eRP-LO) will be an 8-week intervention that includes FOUR virtual visits with a physiotherapist (PT) while eRP-HIgh Intensity (eRP-HI) will be an 8-week intervention with EIGHT virtual weekly visits with a PT. Both interventions will include a progressive resistance exercise program and self-management strategies. Participants will be provided with Theraband to progress exercise intensity, a FitBit to monitor physical activity, an audio-journal to promote self-reflection, and educational materials provided as part of usual OA care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
ReDI@Home will be a randomized, parallel-arm, single-blind (clinical assessor) feasibility trial with participants randomized to eRP-HI or eRP-LO. An uneven block randomization sequence will be computer-generated with a 1:1 group allocation. Randomization will occur after the pre-intervention visit.
The research coordinator will randomize participants after the equipment/software set-up and the pre-intervention assessment has been completed. The assigned intervention PT will contact participants to review the eRP and set up appointments as required based on group assignment. We will use one PT for all eRP-LO participants and up to 2 PTs to provide the eRP-HI intervention. Participants will have the same PT throughout, with visits scheduled during the day or early evening at PT and participant preference/availability, as per our previous COACH study.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present to the Edmonton or Camrose screening clinic with moderate to advanced hip or knee OA not eligible for TJA within one year (i.e., not RA, not currently waiting for TJA)
- •Reside outside of metro Edmonton (defined by StatsCan)
- •Access to a smart phone or tablet with embedded camera that can accept intervention software, with a current data plan in place and/or strong WiFi or ethernet connection*
- •English-speaking
- •Are in need of guided exercise but are a functional community ambulator (with or without aids)
- •Experience hip or knee pain multiple days a week
- •Have activity limitations because of joint pain
排除标准
- •Patients who are not eligible for TJA due to uncontrolled medical conditions (e.g., diabetes, hypertension) will be excluded due to safety concerns (i.e., undertaking exercise in their health state).
结局指标
主要结局
Change in Patient Activation Measure from baseline to post intervention and 6-months and 12-months
时间窗: At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.
Self-management A13-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare. PAM segments individuals into one of four activation levels along an empirically derived 100-point scale. Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals with a low score do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals with higher scores are proactive with their health, have developed strong self management skills, and are resilient in times of stress or change.
次要结局
- Change in Knee Osteoarthritis Outcome Score from baseline to post intervention and 6-months and 12-months(At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Change in Intermittent and Constant Osteoarthritis Pain from baseline to post intervention and 6-months and 12-months(At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Change in Hip Disability and Osteoarthritis Outcome Score from baseline to post intervention and 6-months and 12-months(At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Change in Hospital Anxiety and Depression Scale from baseline to post intervention and 6-months and 12-months(At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Change in Pain Catastrophizing Scale from baseline to post intervention and 6-months and 12-months(At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Change in Sedentary Lifestyle Index and Physical Activity from baseline to post intervention and 6-months and 12-months(At 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Change in Global Rating of Change from baseline to post intervention and 6-months and 12-months(At 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Change in 30-second Chair Stand test from baseline to post intervention and 6-months and 12-months(At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.)
- Canadian Longitudinal Study of Aging(At screening/enrollment)
- Health Literacy Questionnaire(At screening/enrollment)