Digital Osteoarthritis Care- DigiOA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
- 试验地点
- 13
- 主要终点
- Number of responders according to OMERACT-OARSI responder criteria
研究概览
简要总结
Osteoarthritis (OA) is among the most prevalent and costly diseases, with an estimate of $460 billion in all-cause medical costs. It causes pain and reduced physical function, and with no existing cure, the recommended first-line treatment is information, exercise and weight management if indicated. As the prevalence of OA is expected to increase in the coming years, exploring innovative solutions to maintain economical sustainable treatment in the future becomes a necessity. Telerehabilitation, technology which involves providing treatment through information and communication technology, regardless of the patient's geographical location, has shown its potential within cardiac, pulmonary, neurological and musculoskeletal conditions.
Virtual Training (VT) is a generic mobile health application used to deliver digital home exercise programs with text, audio and video support. Through a novel feedback system the therapist is able monitor the patients progress and pain level during exercise. This project aims to investigate, through a randomized controlled trial (RCT), whether the use of the VT-app is as effective as supervised exercise therapy in improving pain, physical function and disease activity in patients with hip and/or knee osteoarthritis. In addition, the investigators want to investigate if the use of the app is more cost effective than supervised exercise therapy, whether the use increases adherence with first line treatment, and whether there are certain characteristics of the patients responding to the intervention.
详细描述
The study is a two-armed non-inferiority randomized controlled trial (RCT) situated in the primary care setting in Norway. Participants diagnosed with hip and/or knee OA will be randomized to either exercise therapy via app or usual care. Patients aged 18 years and older presenting with activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA seeking treatment at physiotherapist working in private practice, will be included if eligible for the study.
The research questions are:
- Is exercise therapy, delivered through a mobile health application (Virtual Training), as effective as supervised exercise therapy in patients with hip and/or knee OA, measured by number of patients classified as responders according to the OMERACT-OARSI responder criteria?
- Is exercise therapy delivered through Virtual Training more cost-effective regarding health care and medication use than supervised exercise therapy for patients with hip and/or knee OA?
- Will patients with hip and/or knee OA, using Virtual Training, be more adherent to exercise during the intervention period compared to patients undergoing supervised exercise therapy, and are there any demographic or clinical factors characterizing the OMERACT-OARSI responding patients using Virtual Training?
The primary analysis will be conducted on an intention-to-treat basis by comparing the proportion of responders at 6 weeks and 3 months post-intervention according to the OMERACT-OARSI responder criteria in the intervention and the control group using logistic regression analysis. Per-protocol analyses will also be conducted. Difference in secondary outcomes will be assessed using analysis of covariance (ANCOVA) on the post-intervention values, with baseline values as covariates.
Cost-effectiveness will be evaluated assessing the difference in health care and medication use and quality of life during 3-month follow-up, reporting the incremental cost-effectiveness ratio (ICER) reflecting the between-group difference in incremental cost per adjusted life years (QALYs). Between-group difference in adherence to exercise will be assessed using linear regression, while patient characteristics in the intervention group will be assessed using logistic regression. Additional analyses assessing associations between physical activity, efficacy, barriers for exercise and OA-related questions will also be assessed in secondary analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA
- •Access to smartphone or tablet
排除标准
- •Neurological disorders
- •Contraindication to physical activity
- •Total hip or knee replacement in the actual joint(s) with no pain/ complaints in the other hip or knee joint(s)
- •Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
- •Malignant illness or other major conditions (e.g. unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended treatment
- •Not understanding the Norwegian language
结局指标
主要结局
Number of responders according to OMERACT-OARSI responder criteria
时间窗: 6 weeks (end of intervention period)
A patient is classified as a responder if one of the following criteria is fulfilled: 1. High improvement in pain or function from baseline to follow-up * ≥50% improvement + absolute change of ≥2 in pain, OR * ≥50% improvement + absolute change of ≥2 in function 2. Improvement in at least two of the three following from baseline to follow-up: * ≥20% improvement + absolute change ≥1 in pain * ≥20% improvement + absolute change ≥1 in function * ≥20% improvement + absolute change ≥1 in the patient´s global assessment of disease activity
次要结局
- Fatigue(18 weeks post randomization)
- Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)(18 weeks post randomization)
- Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)(18 weeks post randomization)
- Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)(18 weeks post randomization)
- Usability of mobile health application, System Usability Scale (SUS)(6 weeks (end of intervention))
- Change in disease activity(Baseline and 18 weeks post randomization)
- General digital competence(Baseline)
- Number of responders according to OMERACT-OARSI responder criteria(18 weeks post randomization)
- Physical performance test, 30 seconds sit to stand test (30 sec STS)(6 weeks (end of intervention period))
- Health-related quality of life, EuroQoL (EQ5D-5L)(18 weeks post randomization)
- Diagnose specific pain experience(18 weeks post randomization)
- Suitability of using an app in exercise therapy(6 weeks (end of intervention))
- Self reported goal achievement, Patient-specific functional scale (PSFS)(18 weeks post randomization)
- Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)(18 weeks post randomization)
- Anxiety and depression, Hopkins symptom checklist (HSCL-5)(18 weeks post randomization)
- Social participation(18 weeks post randomization)
- Usage of medication(18 weeks post randomization)
- Disease activity(18 weeks post randomization)
- Exercise self-efficacy(18 weeks post randomization)
- Use of health care services(18 weeks post randomization)
- Satisfaction with use of app in exercise therapy(6 weeks (end of intervention))
研究者
Anne Therese Tveter
Principal Investigator, Assosiate Professor
Diakonhjemmet Hospital