Digitalization of Osteoarthritis Care

NCT ID: NCT05584410

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Osteoarthritis, Knee Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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App-based model of care

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.

Group Type EXPERIMENTAL

Patient information

Intervention Type OTHER

Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information

Smart phone application based exercises

Intervention Type OTHER

Individually based exercise programs individualized exercises where instructions are given through real-time video or pictures in combination with written descriptions.

Self-monitoring

Intervention Type OTHER

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

Motivational notifications

Intervention Type BEHAVIORAL

Automatic and daily reminders and / or motivational notifications

Web-based model of care

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.

Group Type ACTIVE_COMPARATOR

Patient information

Intervention Type OTHER

Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information

Web based exercises

Intervention Type OTHER

Generic osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description

Home based rehabilitation

Intervention Type OTHER

Individualized exercises that the patient performs on their own, i.e. at home or at a gym.

Standard care

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.

Group Type ACTIVE_COMPARATOR

Patient information

Intervention Type OTHER

Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information

Group based information

Intervention Type OTHER

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).

Supervised rehabilitation

Intervention Type OTHER

The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.

Home based rehabilitation

Intervention Type OTHER

Individualized exercises that the patient performs on their own, i.e. at home or at a gym.

Interventions

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Patient information

Patient education according to national guidelines, with information about e.g. disease progression, symptoms, treatment, exercise, self-care techniques and dietary information

Intervention Type OTHER

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.

Intervention Type OTHER

Web based exercises

Generic osteoarthritis exercise, including about 20 different exercises, provided by real-time videos and written description

Intervention Type OTHER

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).

Intervention Type OTHER

Supervised rehabilitation

The patient is offered to regularly exercise at the clinic, individually or in a group under supervision from a physiotherapist.

Intervention Type OTHER

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

Intervention Type OTHER

Motivational notifications

Automatic and daily reminders and / or motivational notifications

Intervention Type BEHAVIORAL

Home based rehabilitation

Individualized exercises that the patient performs on their own, i.e. at home or at a gym.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Kilhamn, PhD

Role: PRINCIPAL_INVESTIGATOR

Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden

Locations

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Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Susanne Beischer, PhD

Role: CONTACT

+46 (709) 941983

Maziar Mohaddes, Assoc Prof

Role: CONTACT

+46 (730) 701147

Facility Contacts

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Susanne Beischer, PhD

Role: primary

Maziar Mohaddes, PhD, Dr

Role: backup

Other Identifiers

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Digitalization OA care

Identifier Type: -

Identifier Source: org_study_id

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