Digitalization of Osteoarthritis Care

Vastra Gotaland Region

Status: Enrolling

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Treatments: Other: Web based exercises; Other: Patient information; Other: Self-monitoring; Behavioral: Motivational notifications; Other: Home based rehabilitation; Other: Supervised rehabilitation; Other: Group based information; Other: Smart phone application based exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05584410

Digitalization OA care

Details and patient eligibility

About

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

Full description

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.

Enrollment: 315 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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315 participants in 3 patient groups

App-based model of care

Experimental group

Description:

The app-based model of care includes at least one physical visit at the clinic. The majority of the treatment is provided by the app, containing five different sections: 1) My information: specific information regarding osteoarthritis and generic lifestyle advice. 2 \& 3) My exercise \& My plan: individualized exercises where instructions are given through real-time video or pictures and written descriptions. The patient has access to a calendar and an overview of scheduled rehabilitation/exercises and care meetings. 4) My progress: weekly assessment of pain + every six-month with valid patient reported outcome measures and test of function. 5) My messages (asynchronous chat with the responsible physiotherapist). The app sends automatic and daily reminders and / or motivational notifications.

Treatment:

Other: Smart phone application based exercises

Behavioral: Motivational notifications

Other: Self-monitoring

Other: Patient information

Web-based model of care

Active Comparator group

Description:

The patient will get access to information about osteoarthritis and generic osteoarthritis exercises program from a web-based platform Individualization of the training can be done by the responsible physiotherapist informing about changes in the training via the message function and / or during physical follow-up visits. An individualized rehabilitation program can be given to the patient, via the platform or at a physical visit at the clinic, in form of a document with pictures and descriptive information. As long as the patient is under treatment (approximately three months), he/she can contact their responsible physiotherapist by sending a message from the platform.

Treatment:

Other: Home based rehabilitation

Other: Patient information

Other: Web based exercises

Standard care

Active Comparator group

Description:

Patients who are randomized to standard care receive osteoarthritis specific information at three different group meetings (physical or digital) led by a physiotherapist, an occupational therapist and / or dietitian (each rehab clinic makes its own arrangement). After the theory sessions, the patient is booked for another physical visit to the responsible physiotherapist where an individual training program is tested. The patient is then offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.

Treatment:

Other: Group based information

Other: Home based rehabilitation

Other: Supervised rehabilitation

Other: Patient information