Digitalization of Osteoarthritis Care

NCT05584410 | Recruiting

• 1 other identifier: Digitalization OA care
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

physiotherapy; osteoarthritis; digital care

Outcome Measures

Primary Outcomes (2)

• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)

  The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document).

  baseline to 12 months after inclusion

• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale Function in daily living (ADL)

  The KOOS/HOOS questionnaires were developed as instruments to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document).

  baseline to 36 months after inclusion

Secondary Outcomes (27)

• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life

  baseline

• Hip dysfunction/Knee Osteoarthritis Outcome Score (HOOS/KOOS) subscale pain, symptoms, function in sport and recreation, and knee/hip related quality of life

  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

  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

  36 months after inclusion

• The Forgotten joint score (hip/knee) (FJS)

  baseline

Study Arms (3)

App-based model of care

EXPERIMENTAL

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.

Other: Patient information; Other: Smart phone application based exercises; Other: Self-monitoring; Behavioral: Motivational notifications

Web-based model of care

ACTIVE COMPARATOR

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.

Other: Patient information; Other: Web based exercises; Other: Home based rehabilitation

Standard care

ACTIVE COMPARATOR

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.

Other: Patient information; Other: Group based information; Other: Supervised rehabilitation; Other: Home based rehabilitation

Interventions

Patient information OTHER

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

App-based model of care; Standard care; Web-based model of care

Smart phone application based exercises OTHER

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

App-based model of care

Web based exercises OTHER

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

Web-based model of care

Group based information 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).

Standard care

Supervised rehabilitation OTHER

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

Standard care

Self-monitoring 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

App-based model of care

Motivational notifications BEHAVIORAL

Automatic and daily reminders and / or motivational notifications

App-based model of care

Home based rehabilitation OTHER

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

Standard care; Web-based model of care

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis

Interventions

Confidentiality; Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Forensic Psychiatry; Psychiatry; Behavioral Sciences; Behavioral Disciplines and Activities; Patient Rights; Human Rights; Social Control, Formal; Health Care Economics and Organizations; Jurisprudence; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Jan Kilhamn, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Beischer, PhD

CONTACT

+46 (709) 941983; susanne.beischer@gu.se

Maziar Mohaddes, Assoc Prof

CONTACT

+46 (730) 701147; maziar.mohaddes_ardebili@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 18, 2022
• Study Start: December 5, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after publication of results
• Access Criteria: Analyses and additional data are available upon request

Locations

SE (1)