Digitalization of Osteoarthritis Care

Официальное название

Digitalization of the Care for Patients With Hip and Knee Osteoarthritis

Обзор

The overall aim of this study is to compare three different care models for patients with hip- and knee osteoarthritis. The primary aim is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis

Подробное описание

The primary aim of this study is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis. The secondary aims are to evaluate how 1) patient-related outcome measures regarding the ability of the patient to "forget" about their problematic joint after treatment, quality of life, pain-related self-efficacy, and level of physical activity and 2) care consumption, cost-effectiveness, and carbon footprint differ between the three care models in a short-term (three months) and long-term perspective (one and three years respectively). Further aims are to evaluate how patient experience of the benefits provided by the two digital care models differs, how patient experience with respect to work alliance differs between the three care models, describe the adherence to using the app in the app-based care model and to describe what patient characteristics are associated with clinically meaningful improvements in function in daily life among patients recieving app-based care. The primary hypothesis is that patients who are randomized to an app-based care model will improve significantly more in terms of function in daily life from baseline to one year compared with patients who are randomized to a web-based model and usual care. The secondary hypothesis is that patients randomized to the app-based care model change equivalently from baseline to one year in terms of patient-reported measures, but that the app-based care model is more cost-effective compared with the other two care models at one and three years, respectively.

Вмешательства

• Другое Patient information
  Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
• Другое Smart phone application based exercises
  Individually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions.
• Другое Web based exercises
  Generic osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description
• Другое Group based information
  Osteoarthritis specific information at three different group meeting (physical or digital) led by a physiotherapist, an occupational therapist and / or dietitian (each rehab clinic makes its own arrangement).
• Другое Supervised rehabilitation
  The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.
• Другое Self-monitoring
  Patients will be followed by validated questionnaires and function tests (30 sec Chair-to-stand test) every six months until three years after the start of treatment. The patients will get a report of the results and a research coordinator will contact the patients if their symptoms/function has worsen and discuss further treatment
• Поведенческое Motivational notifications
  Automatic and daily reminders and / or motivational notifications
• Другое Home based rehabilitation
  Individualized exercises that the patient performs on their own, i.e. at home or at a gym.

Первичные конечные точки

• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL) [Срок оценки: baseline to 12 months after inclusion]
• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL) [Срок оценки: baseline to 36 months after inclusion]

Вторичные конечные точки (12)

• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life [Срок оценки: baseline]
• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life [Срок оценки: 3 months after inclusion]
• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life [Срок оценки: 12 months after inclusion]
• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life [Срок оценки: 36 months after inclusion]
• The Forgotten joint score (hip/knee) (FJS) [Срок оценки: baseline]
• The Forgotten joint score (hip/knee) (FJS) [Срок оценки: 3 months after inclusion]
• The Forgotten joint score (hip/knee) (FJS) [Срок оценки: 12 months after inclusion]
• The Forgotten joint score (hip/knee) (FJS) [Срок оценки: 36 months after inclusion]
• Swedish National Board of Health and Welfare questions about physical activity [Срок оценки: baseline]
• Swedish National Board of Health and Welfare questions about physical activity [Срок оценки: 3 months after inclusion]
• Swedish National Board of Health and Welfare questions about physical activity [Срок оценки: 12 months after inclusion]
• Swedish National Board of Health and Welfare questions about physical activity [Срок оценки: 36 months after inclusion]

Критерии участия

Критерии включения

The participant:

• has given their written consent to participate in the study
• has been referred to the orthopaedic clinic at Sahlgrenska University Hospital /Mölndal for primary hip- and or knee osteoarthritis
• has a positive attitude in using digital tools
• has access to a smart phone / tablet
• has been assessed not to be in need of hip or knee surgery trough triage based on a patient reported outcome (the Osteoarthritis Guidelines Instrument)

Критерии исключения

Patients:

• with secondary osteoarthritis (due to osteonecrosis)
• referred to a specific orthopaedic surgeon
• with impaired mental ability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study
• who undergo treatment, have disability or illness that according to the research group can affect the treatment or the study result

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Sahlgrenska University Hospital — Gothenburg

Идентификаторы

NCT: NCT05584410 · Digitalization OA care

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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