Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05584410

Digitalization of Osteoarthritis Care

Digitalization of the Care for Patients With Hip and Knee Osteoarthritis

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
315 (estimated)
Sponsor
Vastra Gotaland Region · Other Government
Sex
All
Age
20 Years – 90 Years
Healthy volunteers
Not accepted

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

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.

Conditions

Interventions

TypeNameDescription
OTHERPatient informationPatient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information
OTHERSmart phone application based exercisesIndividually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions.
OTHERWeb based exercisesGeneric osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description
OTHERGroup based informationOsteoarthritis 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).
OTHERSupervised rehabilitationThe patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.
OTHERSelf-monitoringPatients 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
BEHAVIORALMotivational notificationsAutomatic and daily reminders and / or motivational notifications
OTHERHome based rehabilitationIndividualized exercises that the patient performs on their own, i.e. at home or at a gym.

Timeline

Start date
2022-12-05
Primary completion
2025-12-31
Completion
2028-12-31
First posted
2022-10-18
Last updated
2025-05-31

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05584410. Inclusion in this directory is not an endorsement.