Effect of an Information- and Self-management App for People With Knee Osteoarthritis (OA-AID)

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Information- and self-management app; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne Therese Tveter, PhD; Phone Number: +4791115550; Email: a.t.tveter@medisin.uio.no

Study Locations

• Norway
  • Oslo
    • Oslo, Oslo, Norway, 0317
      • Recruiting
      • Diakonhjemmet Hospital
      • Contact: Anne Therese Tveter, PhD; Phone Number: +4791115550; Email: a.t.tveter@medisin.uio.no
      • Contact: Tuva Moseng, PhD; Phone Number: +4747306697; Email: tuva.moseng@diakonsyk.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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
Active Comparator: Control group; Getting access to publicly available information in the waiting period from referral to consultation in specialist healthcare	Other: Control; Information on where to access publically available information about knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	approx. 2-4 months after baseline (1 day after consultation (post consultation))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance between preferences and treatment decision	Measured with one qustion form the Decision Conflict Scale (DSC), 5 response options.	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.	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	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)	approx. 2-4 months after baseline (1 day after consultation (post consultation))

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation for exercise	Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation	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	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	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	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	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.	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	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	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	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.	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.	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).	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).	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)	Baseline, 8 weeks, 1 and 2 years
Fatigue	Measured on a numeric rating scale from 0 (no fatigue) to 10 (worst possible fatigue)	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)	Baseline, 8 weeks
Preferred treatment	Measured with a question about if they prefer surgery or non-surgical treatment	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	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	Baseline
Previous treatment	Assessment of previous treatment, answered with yes/no on questions related to previous physiotherapy treatment, previous osteoarthritis school,	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)	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	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)	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	Baseline
Antropometrics	Measured as self-reported hight and weight	Baseline
Joint-spesific information	Measured with questions about most trouble some knee, duration of complaints, other joints with complaints	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	Baseline, 8 weeks, 1 and 2 years
Comorbidities	Assessed with 15 questions about the presens of different diseases (yes/no)	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	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)	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)	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	1 and 2 years

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: knee osteoarthritis; self-management; app; information; evidence-based treatment; digital support tool
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Arthritis; Joint Diseases; Rheumatic Diseases; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Osteoarthritis; Alzheimer Disease; Osteoarthritis, Knee
• Other Study ID Numbers: DS-00926; 938916 (Other Identifier: Regional committees for medical and health research ethics (REK)); CIV-25-08-053975 (Other Identifier: Eudamed CIV ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to GDPR regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No