Effect of an Information- and Self-management App for People With Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Information- and self-management app, Control.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The primary aim of the trial is to assess if an information- and self-management app provided in the period between referral and consultation in specialist healthcare can improve knowledge about osteoarthritis and decision quality during consultation in patients with knee osteoarthritis. 204 patients will be randomized to either being on the waiting list for consultation, accessing publically available information about osteoarthritis (control group) or getting access to an 8-week information- and self-management intervention delivered through the Genus app prior to consultation. Pasients with answer questionnaires at baseline, 4 weeks (intervention group only), 8 weeks, post consultation and 1 and 2 years after consultation. The Genus app contains information videos, exercise videos, quizzes, feedback and questionnaires provided in a progressive order over an 8 week period.
Interventions
- Device Information- and self-management app
An information- and self-management intervention delivered through the Genus app, including information videos, exercise videos, questionnaires, quizzes and feedback provided over an 8 week period prior to consultation in specialist healthcare - Other Control
Information on where to access publically available information about knee osteoarthritis
Primary outcome measures
- Knee Osteoathritis Knowlegde Scale (KOAKS) [Time frame: Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))]
- Decision Conflict Scale (DCS) [Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))]
Secondary outcome measures (4)
- Concordance between preferences and treatment decision [Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))]
- Decisional quality [Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))]
- Level of shared decision-making [Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))]
- Satisfaction with treatment choice [Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))]
Eligibility criteria
Inclusion criteria
- Men and women > 50 years referred to specialist healthcare for knee OA management
Exclusion criteria
- Received joint replacement or are under consideration for revision in the referred joint
- Have undergone joint replacement surgery in opposite knee
- Have uncontrolled serious comorbidities
- Have cognitive deficits
- Are seeking care for recent knee trauma conditions (less than 6 months after trauma) or mainly psoriatic/rheumatoid arthritis
- Unable to understand Norwegian
- Do not possess a smartphone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Diakonhjemmet Hospital — Oslo
Identifiers
NCT: NCT07603973 · DS-00926 · 938916 · CIV-25-08-053975