An interventional study of Information- and self-management app and Control in Knee Osteoarthritis, sponsored by Diakonhjemmet Hospital. Recruiting at 1 site in Norway. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Treatment
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 204 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Getting access to an information- and self-management app in the waiting period from referral to consultation in specialist healthcare
Device: Information- and self-management app
Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare
Other: Control
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
Information on where to access publically available information about knee osteoarthritis
Knee Osteoathritis Knowlegde Scale (KOAKS)
11 statements about osteoarthritis and treatment options, answered on a 5-point scale from 1 (=true) to 5 (=not true), summed up to a scale from 11 to 55
Time frame: Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))
Decision Conflict Scale (DCS)
16 statements with 5 response categories about the patients uncertainty with treatment options. The total score range from 0 (no decisional conflict) to 100 (extreme decisional conflict). The DCS also has five subscales (all 0-100): 1) uncertainty, 2) informed, 3) values clarity, 4) support, and 5) effective decision.
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Concordance between preferences and treatment decision
Measured with one qustion form the Decision Conflict Scale (DSC), 5 response options.
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Decisional quality
Measured with section 3 (decision process scale) in the Decision Quality Index for Knee Osteoarthritis (K-DQI) which consists of 5 questions. Four of these questions are summed to a 0-4 score with higher score indicating more shared decision-making.
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Level of shared decision-making
Mesured with the CollaboRATE questionnaire, comprising 3 questions measured on a 0-9 scale, with a higher score indicating better experience. Scores are calculated using the top score method indicating the percentage of patients scoring top score for all three questions, or
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Satisfaction with treatment choice
Measured on a numeric rating scale (0-10, with higher score indicating more satisfaction)
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Motivation for exercise
Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
Time frame: Baseline, 4 weeks (only intervention group), 8 weeks
Motivation for surgery
Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation
Time frame: Baseline, 4 weeks (only intervention group), 8 weeks
Assessment of knee-related pain
Measured with the Knee Injury and Osteoarthritis Outcome Score (pain section), comprising 9 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Assessment of knee-related function
Measured with the Knee Injury and Osteoarthritis Outcome Score (function section), comprising 17 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Assessment of knee-related quality of life
Measured with the Knee Injury and Osteoarthritis Outcome Score (quality of life section), comprising 4 questions scored on a 5-point scale and calculated to a 0-100 score with higher score indicating less pain
Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Health-related quality of life
Mesured with EQ-5D-5L, comprising 5 questions with 5 response options. Summed to an utility index from 1 to 0, with 1 being best health-related quality of life. Additionally a visual analog scale from 0 to 100 with 100 indicating best health.
Time frame: Baseline, 1 and 2 years
Level of shared decision-making therapist
Measured with 7 statements from the MAPPIN'SDM Therapist, measured on a 5-point scale
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Preferred decision-making role
Measured with the Control Preference Scale, comprising a question with 5 statements about roles, corresponding to active role, collaborative role and passive role
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Illness perception
Measured with the Brief Illness Perception Questionnaire (B-IPQ) comprising 8 questions scored on a 0-10 scale, summed to a 0 to 80 score with higher score indicating poorer illness perception
Time frame: Baseline, 8 weeks
Pain self-efficacy
Measured with the Pain Self-Efficacy Questionnaire (PSEQ-2) comprising 2 questions about pain self-efficacy, answered on a 0 (not at all confident) to 6 (completely confident) scale.
Time frame: Baseline, 8 weeks
Pain catastrophizing
Measured with one question about consern about pain, measured on a 0 (not at all) to 4 (all the time) scale.
Time frame: Baseline, 8 weeks
Pain intensity
Measured with four questions from the Brief Pain Inventory, assessed on numeric rating scales from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, 8 weeks
Pain intensity now
Measured with one question about pain intensity now on a numeric rating scale from 0 (no pain) to 10 (worst possible pain).
Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years
Disease activity
Measured with a numeric rating scale from 0 (no disease activity) to 10 (worst disease activity)
Time frame: Baseline, 8 weeks, 1 and 2 years
Fatigue
Measured on a numeric rating scale from 0 (no fatigue) to 10 (worst possible fatigue)
Time frame: Baseline, 8 weeks, 1 and 2 years
Importance of treatment options
Measured with five questions from Dicision Quality Index for Knee Osteoarthritis (section 1). Assessed on numeric rating scales from 0 (not at all important) to 10 (extremely important)
Time frame: Baseline, 8 weeks
Preferred treatment
Measured with a question about if they prefer surgery or non-surgical treatment
Time frame: Baseline, 8 weeks
Health literacy
Measured with the HLS19-Q12 comprising 12 questions about health literacy answered on a 4-point likert scale from 1 (very difficult) to 4 (very easy). Calculated as percentage (0-100) of items with valid responses that were answered with very easy or easy
Time frame: Baseline
Self-efficacy of digital solutions
Measured with six questions about the self-efficacy of using different digital solutions (mobile phone, tablet, computer, apps, identification portal, helsenorge.no), assessed on a 6-point scale from never tried to manage very well
Time frame: Baseline
Previous treatment
Assessment of previous treatment, answered with yes/no on questions related to previous physiotherapy treatment, previous osteoarthritis school,
Time frame: Baseline
Health problems impact on daily living
Measured with one question from the Work Productivity and Activity Impairment questionnaire (WPAI) (question 6), anwered on a numeric rating scale from 0 (no effect on daily activities) to 10 (completely prevent from doing daily activities)
Time frame: Baseline, 8 weeks, 1 and 2 years
Decision regret
Measured with item 2 from the Decision regret scale, answered on a 5-point scale from totally agree to totally disagree
Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))
Use of pain medication
Assessed with an open-ended question about the use of pain medication last three months (type and dosage)
Time frame: Baseline, 8 weeks, 1 and 2 years
Demographics
Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support
Time frame: Baseline
Antropometrics
Measured as self-reported hight and weight
Time frame: Baseline
Joint-spesific information
Measured with questions about most trouble some knee, duration of complaints, other joints with complaints
Time frame: Baseline
Exercise level
Measured with one question about exercise level answered on a 5-point scale from do not exercise to exercise 3 or more times per week
Time frame: Baseline, 8 weeks, 1 and 2 years
Comorbidities
Assessed with 15 questions about the presens of different diseases (yes/no)
Time frame: Baseline
Usability of the app
Measured with System Usability Scale (SUS) comprising 10 statements answered on a 5-point scale from strongly disagree to strongly agree, converted to a 0 to 100 score with higher score indicating better usability
Time frame: 8 weeks (only intervention group)
Satisfaction with the app
Measured with two questions about the satisfaction with the information videos and exercise videos in the app, answered on numeric rating scales from 0 (not statisfied) to 10 (very satisfied)
Time frame: 8 weeks (only the intervention group)
Suitability of the app
Measured with two questions about the suitability of providing information and exercises through an app, answered on numeric rating scales from 0 (not suitable) to 10 (very suitable)
Time frame: 8 weeks (only the intervention group)
Surgical treatment
Measured with a question about whether the patient has undergone surgical treatment (yes/no) and for those answering yes; five questions about the improvement/satisfaction with the surgical treatment, measured on a 5-point scale from very satisfied to very dissatisfied
Time frame: 1 and 2 years
Plan to share: No — IPD will not be shared due to GDPR regulations
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