Thinking of joining a study?

Register your interest

NCT05584410 | RECRUITING | Osteoarthritis, Knee


Digitalization of Osteoarthritis Care
Sponsor:

Clothing gotland region

Brief Summary:

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

Condition or disease

Osteoarthritis, Knee

Osteoarthritis, Hip

Intervention/treatment

Patient information

Smart phone application based exercises

Web based exercises

Group based information

Supervised rehabilitation

Self-monitoring

Motivational notifications

Home based rehabilitation

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 315 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Digitalization of the Care for Patients With Hip and Knee Osteoarthritis
Actual Study Start Date : 2022-12-05
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 20 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Digitalization of Osteoarthritis Care

Location Details

NCT05584410


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

Sweden, Västra Götaland

Sahlgrenska University Hospital

Gothenburg, Västra Götaland, Sweden,

Loading...