Adapting Rehabilitation Delivery for Maximum Impact at Home-2 (ReDI-2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Patient Activation Measure (PAM)
研究概览
简要总结
People who live in rural areas and have hip or knee arthritis can have difficulty receiving physical therapy (PT) close to home. Living with hip or knee arthritis can make doing daily activities and being physically active difficult. This can lead to other health conditions, such as becoming overweight, or lessen enjoyment of life.
We will compare 2 programs that allow physical therapists to treat rural residents in their own home to each other and to usual care. Usual care is the care that is typically provided to people living with hip or knee arthritis.
For the first 12 weeks, participants will continue usual osteoarthritis (OA) care and then complete the standardized questionnaires again. Then, they will be randomized to either Individual (IPT) or Group-based PT (GPT).
Over 12-weeks, therapists will meet virtually with patients using Zoom so that patients and therapists can see each other. The program will be either a class or one-on-one with a therapist. In the class, participants will still receive private one-to-one time with the therapist using a Zoom 'breakout' room. Therapists in both groups will help patients do exercises correctly in their home. Patients can also see and talk to the therapists to discuss their challenges in living with OA and set personalized goals including pain management, participating in valued daily activities, keeping healthy (diet, sleep) and being active. Both programs will allow patients who sometimes cannot access physical therapy to receive care in their home.
详细描述
Adapting Rehabilitation Delivery for Maximum Impact at Home-2 (ReDI-2) is a randomized clinical trial (RCT) that will assess the impact of 12-weeks of community-based osteoarthritis (OA) usual care and then compare two 12-week virtual home-based rehabilitation programs (IPT or GPT) for rural Albertans living with hip and/or knee OA to each other and to usual care. ReDI-2 aims to improve self-management through patient activation. Program content will be identical with only the delivery format differing between groups.
IPT will be one-to-one virtual PT for OA self-management including education, exercise and personalized goal-setting, including physical activity goals.
GPT will use 2 PTs and 4-5 participants/class. One therapist will provide personalized goal-setting with each participant via a Zoom 'breakout' room, while the 2nd therapist leads group-based therapy in the 'main' Zoom room comprised of education and exercises individualized to participants' capacity.
Objectives and Hypotheses Primary Objective: To compare the effectiveness of 12-weeks of virtual IPT or GPT, to each other and to 12-weeks of usual care, in rural Albertans living with hip or knee OA, on changes in self-management measured through patient activation, using the validated 13-item Patient Activation Measure (PAM).
Secondary Objectives: 1) To compare the effectiveness of a) virtual IPT and GPT to each other and to usual care post-intervention in rural Albertans living with hip or knee OA in terms of HRQL, understanding pain management, improving step count (as a measure of physical activity), pain, and function, including physical performance, and b) primary and secondary outcomes up to 12-months post-intervention; and 2) To explore how patient and program characteristics affect outcomes in each model, which may highlight responders/non-responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with confirmed hip or knee OA, but deemed to not require total joint arthroplasty (i.e., not on the surgical waitlist)
- •Not currently be attending physiotherapy
- •Reside outside of Edmonton or nearby communities
- •English-speaking
- •with access to a Zoom-friendly device (smart phone, tablet, laptop).
排除标准
- •Patients who are not meeting the inclusion criteria are not eligible.
研究组 & 干预措施
Individual Physical Therapy (IPT)
12-week virtual physical therapy that includes one-on-one visits with a physiotherapist.
干预措施: Individual-based Virtual Physical Therapy Program (Behavioral)
Group-based Physical Therapy (GPT)
12-week virtual physical therapy that includes group classes (4-5 participants) with two physiotherapists. In each session, each participant will also have a 10-12 min one-on-one interaction with one of the physiotherapists.
干预措施: Group-based Virtual Physical Therapy Program (Behavioral)
结局指标
主要结局
Patient Activation Measure (PAM)
时间窗: pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention
Self-management will be measured using the validated 13-item Patient Activation Measure (PAM). Responses are scored to a total score on a 0-100-point scale with higher scores representing higher patient activation.
Patient Activation Measure (PAM)
时间窗: pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention
Self-management will be measured using the validated 13-item Patient Activation Measure (PAM). Responses are scored to a total score on a 0-100-point scale with higher scores representing higher patient activation.
次要结局
- Pain - Numeric Rating Scale (NRS)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Pain Catastrophizing Scale (PCS)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Knee Osteoarthritis Outcome Score (KOOS) - Health-Related Quality of life (HRQL)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Knee Osteoarthritis Outcome Score (KOOS) - Daily Living Function(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Hip Osteoarthritis Outcome Score (HOOS) - Health-Related Quality of life (HRQL)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Hip Osteoarthritis Outcome Score (HOOS) - Daily Living Function(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Euro-Quality of Life-5 Dimension-5 Level (EQ-5D-5L)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- 30-second Chair Stand test(pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Fitbit Step count(pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/pain - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/function - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/physical activity - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/OA self-management - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/satisfaction - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Telehealth Usability Questionnaire - Patient(immediate post-intervention)
- Global rating of change/satisfaction - Provider(immediate post-intervention)
- Telehealth Usability Questionnaire - Provider(immediate post-intervention)
- Pain Catastrophizing Scale (PCS)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Knee Osteoarthritis Outcome Score (KOOS) - Health-Related Quality of life (HRQL)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Knee Osteoarthritis Outcome Score (KOOS) - Daily Living Function(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Hip Osteoarthritis Outcome Score (HOOS) - Health-Related Quality of life (HRQL)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Hip Osteoarthritis Outcome Score (HOOS) - Daily Living Function(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Euro-Quality of Life-5 Dimension-5 Level (EQ-5D-5L)(pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- 30-second Chair Stand test(pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Fitbit Step count(pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/pain - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/function - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/physical activity - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/OA self-management - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Global rating of change/satisfaction - Patient(pre-intervention (post-usual care), immediate post-intervention, 6-months post-intervention,12-months post-intervention)
- Telehealth Usability Questionnaire - Patient(immediate post-intervention)
- Telehealth Usability Questionnaire - Provider(immediate post-intervention)