Clinical trial NCT04767854: Digital Osteoarthritis Care
Official title: Digital Osteoarthritis Care- DigiOA
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Telerehabilitation
Digital care
mHealth
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: The Dam Foundation
name: The Norwegian Council for Musculoskeletal Health
First posted: 2021-02-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study is a two-armed non-inferiority randomized controlled trial (RCT) situated in the primary care setting in Norway. Participants diagnosed with hip and/or knee OA will be randomized to either exercise therapy via app or usual care. Patients aged 18 years and older presenting with activity-related hip and/or knee pain/complaints and clinical signs and symptoms corresponding to hip and/or knee OA seeking treatment at physiotherapist working in private practice, will be included if eligible for the study.

The research questions are:

1. Is exercise therapy, delivered through a mobile health application (Virtual Training), as effective as supervised exercise therapy in patients with hip and/or knee OA, measured by number of patients classified as responders according to the OMERACT-OARSI responder criteria?
2. Is exercise therapy delivered through Virtual Training more cost-effective regarding health care and medication use than supervised exercise therapy for patients with hip and/or knee OA?
3. Will patients with hip and/or knee OA, using Virtual Training, be more adherent to exercise during the intervention period compared to patients undergoing supervised exercise therapy, and are there any demographic or clinical factors characterizing the OMERACT-OARSI responding patients using Virtual Training?

The primary analysis will be conducted on an intention-to-treat basis by comparing the proportion of responders at 6 weeks and 3 months post-intervention according to the OMERACT-OARSI responder criteria in the intervention and the control group using logistic regression analysis. Per-protocol analyses will also be conducted. Difference in secondary outcomes will be assessed using analysis of covariance (ANCOVA) on the post-intervention values, with baseline values as covariates.

Cost-effectiveness will be evaluated assessing the difference in health care and medication use and quality of life during 3-month follow-up, reporting the incremental cost-effectiveness ratio (ICER) reflecting the between-group difference in incremental cost per adjusted life years (QALYs). Between-group difference in adherence to exercise will be assessed using linear regression, while patient characteristics in the intervention group will be assessed using logistic regression. Additional analyses assessing associations between physical activity, efficacy, barriers for exercise and OA-related questions will also be assessed in secondary analyses.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of responders according to OMERACT-OARSI responder criteria
timeFrame: 6 weeks (end of intervention period)
Secondary outcomes:
measure: Number of responders according to OMERACT-OARSI responder criteria
timeFrame: 18 weeks post randomization
measure: Physical performance test, 30 seconds sit to stand test (30 sec STS)
timeFrame: Baseline
measure: Physical performance test, 30 seconds sit to stand test (30 sec STS)
timeFrame: 6 weeks (end of intervention period)
measure: Self reported goal achievement, Patient-specific functional scale (PSFS)
timeFrame: Baseline
measure: Self reported goal achievement, Patient-specific functional scale (PSFS)
timeFrame: 6 weeks (end of intervention period)
measure: Self reported goal achievement, Patient-specific functional scale (PSFS)
timeFrame: 18 weeks post randomization
measure: Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Baseline
measure: Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 6 weeks (end of intervention period)
measure: Hip pain and function, Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 18 weeks post randomization
measure: Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline
measure: Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 weeks (end of intervention period)
measure: Knee pain and function, Knee disability and Osteoarthritis Outcome Score (KOOS)
timeFrame: 18 weeks post randomization
measure: Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
timeFrame: Baseline
measure: Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
timeFrame: 6 weeks (end of intervention)
measure: Self-reported physical activity, International Physical Activity Questionnaire-Short Form (IPAQ)
timeFrame: 18 weeks post randomization
measure: Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
timeFrame: Baseline
measure: Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
timeFrame: 6 weeks (end of intervention)
measure: Self-reported self-efficacy, Arthritis Self-Efficacy Scale (ASES)
timeFrame: 18 weeks post randomization
measure: Exercise self-efficacy
timeFrame: Baseline
measure: Exercise self-efficacy
timeFrame: 6 weeks (end of intervention)
measure: Exercise self-efficacy
timeFrame: 18 weeks post randomization
measure: Health-related quality of life, EuroQoL (EQ5D-5L)
timeFrame: Baseline
measure: Health-related quality of life, EuroQoL (EQ5D-5L)
timeFrame: 6 weeks (end of intervention)
measure: Health-related quality of life, EuroQoL (EQ5D-5L)
timeFrame: 18 weeks post randomization
measure: Anxiety and depression, Hopkins symptom checklist (HSCL-5)
timeFrame: Baseline
measure: Anxiety and depression, Hopkins symptom checklist (HSCL-5)
timeFrame: 6 weeks (end of intervention)
measure: Anxiety and depression, Hopkins symptom checklist (HSCL-5)
timeFrame: 18 weeks post randomization
measure: Social participation
timeFrame: Baseline
measure: Social participation
timeFrame: 6 weeks (end of intervention)
measure: Social participation
timeFrame: 18 weeks post randomization
measure: Usability of mobile health application, System Usability Scale (SUS)
timeFrame: 6 weeks (end of intervention)
measure: Usage of medication
timeFrame: Baseline
measure: Usage of medication
timeFrame: 18 weeks post randomization
measure: Change in disease activity
timeFrame: Baseline and 6 weeks (end of intervention)
measure: Change in disease activity
timeFrame: Baseline and 18 weeks post randomization
measure: Disease activity
timeFrame: Baseline
measure: Disease activity
timeFrame: 6 weeks (end of intervention)
measure: Disease activity
timeFrame: 18 weeks post randomization
measure: Diagnose specific pain experience
timeFrame: Baseline
measure: Diagnose specific pain experience
timeFrame: 6 weeks (end of intervention)
measure: Diagnose specific pain experience
timeFrame: 18 weeks post randomization
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: 6 weeks (end of intervention)
measure: Fatigue
timeFrame: 18 weeks post randomization
measure: Use of health care services
timeFrame: 6 weeks (end of intervention)
measure: Use of health care services
timeFrame: 18 weeks post randomization
measure: General digital competence
timeFrame: Baseline
measure: Satisfaction with use of app in exercise therapy
timeFrame: 6 weeks (end of intervention)
measure: Suitability of using an app in exercise therapy
timeFrame: 6 weeks (end of intervention)
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Laguneparken fysioterapi/Arna fysikalske
city: Bergen
country: Norway
facility: Sandviken fysioterapi og trening
city: Drammen
country: Norway
facility: Trimmen
city: Gjøvik
country: Norway
facility: Sentrum Fysioterapi
city: Indre Østfold
country: Norway
facility: Ace Treningssenter
city: Indre Østfold
country: Norway
facility: Trøgstad fysioterapi
city: Nittedal
country: Norway
facility: Nittedal fysikalske institutt
city: Notodden
country: Norway
facility: Physiotherapist Stein Listaul
city: Oslo
country: Norway
facility: Aktifys Institutt
city: Oslo
country: Norway
facility: Furuset Fysioterapi
city: Oslo
country: Norway
facility: Røa Centrum Fysioterapi og Akupunktur
city: Skiptvet
country: Norway
facility: Skiptvet Fysikalske
city: Ski
country: Norway
facility: Ski Fysioterapisenter
Study officials:
affiliation: Diakonhjemmet Hospital
name: Anne Therese Tveter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.