Digital Osteoarthritis Care

NCT04767854 | Active Not Recruiting

• 1 other identifier: 2021/FO347383
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 13

Brief Summary

Osteoarthritis (OA) is among the most prevalent and costly diseases, with an estimate of $460 billion in all-cause medical costs. It causes pain and reduced physical function, and with no existing cure, the recommended first-line treatment is information, exercise and weight management if indicated. As the prevalence of OA is expected to increase in the coming years, exploring innovative solutions to maintain economical sustainable treatment in the future becomes a necessity. Telerehabilitation, technology which involves providing treatment through information and communication technology, regardless of the patient's geographical location, has shown its potential within cardiac, pulmonary, neurological and musculoskeletal conditions. Virtual Training (VT) is a generic mobile health application used to deliver digital home exercise programs with text, audio and video support. Through a novel feedback system the therapist is able monitor the patients progress and pain level during exercise. This project aims to investigate, through a randomized controlled trial (RCT), whether the use of the VT-app is as effective as supervised exercise therapy in improving pain, physical function and disease activity in patients with hip and/or knee osteoarthritis. In addition, the investigators want to investigate if the use of the app is more cost effective than supervised exercise therapy, whether the use increases adherence with first line treatment, and whether there are certain characteristics of the patients responding to the intervention.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Telerehabilitation; Digital care; mHealth

Outcome Measures

Primary Outcomes (1)

• Number of responders according to OMERACT-OARSI responder criteria

  A patient is classified as a responder if one of the following criteria is fulfilled: 1. High improvement in pain or function from baseline to follow-up * ≥50% improvement + absolute change of ≥2 in pain, OR * ≥50% improvement + absolute change of ≥2 in function 2. Improvement in at least two of the three following from baseline to follow-up: * ≥20% improvement + absolute change ≥1 in pain * ≥20% improvement + absolute change ≥1 in function * ≥20% improvement + absolute change ≥1 in the patient´s global assessment of disease activity

  6 weeks (end of intervention period)

Secondary Outcomes (49)

• Number of responders according to OMERACT-OARSI responder criteria

  18 weeks post randomization

• Physical performance test, 30 seconds sit to stand test (30 sec STS)

  Baseline

• Physical performance test, 30 seconds sit to stand test (30 sec STS)

  6 weeks (end of intervention period)

• Self reported goal achievement, Patient-specific functional scale (PSFS)

  Baseline

• Self reported goal achievement, Patient-specific functional scale (PSFS)

  6 weeks (end of intervention period)

Study Arms (2)

OA school + Virtual Training mobile health application

EXPERIMENTAL

After a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines. The intervention group will receive an individually tailored exercise program through the Virtual Training mobile health application. After each exercise the patient score his/her execution of the exercise on a Likert-scale of 1 to 5, judging their effort from very poor to very good. After the session, patients rate their pain on a Numeric Rating Scale from 0 to 10. The patients in the intervention group will be instructed to exercise 3 times per week for 6 weeks. If the patients want to exercise more than 3 times per week, the exercise program will be available in the app once every day.

Behavioral: OA school; Other: Virtual Training mobile health application

OA school + usual care

ACTIVE COMPARATOR

After a clinical examination by the physiotherapist, all patients will receive a 1-2-hour group session of patient education according to guidelines. The control group will receive individually tailored supervised exercise therapy by a physiotherapist individually or in a group setting, twice a week for 6 weeks. Additionally, the patients will be motivated to perform one session of home exercise a week, a total of 3 sessions per week

Behavioral: OA school; Other: Usual care

Interventions

OA school BEHAVIORAL

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

OA school + Virtual Training mobile health application; OA school + usual care

Virtual Training mobile health application OTHER

Individually tailored home exercise programs delivered through a mobile health application

OA school + Virtual Training mobile health application

Usual care OTHER

Individually tailored exercise programs conducted in weekly supervised individual or group sessions

OA school + usual care

Eligibility Criteria

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

You may qualify if:

• Activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA
• Access to smartphone or tablet

You may not qualify if:

• Neurological disorders
• Contraindication to physical activity
• Total hip or knee replacement in the actual joint(s) with no pain/ complaints in the other hip or knee joint(s)
• Inflammatory rheumatic diseases (e.g. rheumatoid arthritis, spondyloarthritis)
• Malignant illness or other major conditions (e.g. unstable cardiovascular disorders or lung disease, dementia) that restrict the ability to adhere to the recommended treatment
• Not understanding the Norwegian language

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• The Dam Foundation: collaborator
• The Norwegian Council for Musculoskeletal Health: collaborator

Study Sites (13)

Laguneparken fysioterapi/Arna fysikalske

Bergen, Norway

Location

Sandviken fysioterapi og trening

Bergen, Norway

Location

Trimmen

Drammen, Norway

Location

Sentrum Fysioterapi

Gjøvik, Norway

Location

Ace Treningssenter

Indre Østfold, Norway

Location

Trøgstad fysioterapi

Indre Østfold, Norway

Location

Nittedal fysikalske institutt

Nittedal, Norway

Location

Physiotherapist Stein Listaul

Notodden, Norway

Location

Aktifys Institutt

Oslo, Norway

Location

Furuset Fysioterapi

Oslo, Norway

Location

Røa Centrum Fysioterapi og Akupunktur

Oslo, Norway

Location

Ski Fysioterapisenter

Ski, Norway

Location

Skiptvet Fysikalske

Skiptvet, Norway

Location

Related Publications (2)

• Martinsen L, Osteras N, Moseng T, Tveter AT. Adherence to in-person and app-based exercise for patients with hip or knee osteoarthritis; secondary analyses from a randomized controlled trial. Rheumatol Int. 2025 Aug 26;45(9):208. doi: 10.1007/s00296-025-05967-4.

  PMID: 40856813 DERIVED

• Martinsen L, Osteras N, Moseng T, Tveter AT. Effect of a mHealth exercise intervention compared with supervised exercise therapy in osteoarthritis management: protocol of the DigiOA trial. BMJ Open. 2022 Sep 23;12(9):e066248. doi: 10.1136/bmjopen-2022-066248.

  PMID: 36153027 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anne Therese Tveter, PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assosiate Professor

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 23, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (13)