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NCT Number: NCT07603973

Effect of an Information- and Self-management App for People With Knee Osteoarthritis

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Information- and self-management app

Device

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

Control

Other

Information on where to access publically available information about knee osteoarthritis

Primary outcomes

  1. Knee Osteoathritis Knowlegde Scale (KOAKS)

    Time frame: Baseline, 8 weeks, approx. 2-4 months after baseline (1 day after consultation (post consultation))

    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

  2. Decision Conflict Scale (DCS)

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    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.

Secondary outcomes

  1. Concordance between preferences and treatment decision

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    Measured with one qustion form the Decision Conflict Scale (DSC), 5 response options.

  2. Decisional quality

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    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.

  3. Level of shared decision-making

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    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

  4. Satisfaction with treatment choice

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    Measured on a numeric rating scale (0-10, with higher score indicating more satisfaction)

Other outcomes

  1. Motivation for exercise

    Time frame: Baseline, 4 weeks (only intervention group), 8 weeks

    Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation

  2. Motivation for surgery

    Time frame: Baseline, 4 weeks (only intervention group), 8 weeks

    Measured on a numeric rating scale from 0 to 10 with higher score indicating higher motivation

  3. Assessment of knee-related pain

    Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years

    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

  4. Assessment of knee-related function

    Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years

    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

  5. Assessment of knee-related quality of life

    Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years

    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

  6. Health-related quality of life

    Time frame: Baseline, 1 and 2 years

    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.

  7. Level of shared decision-making therapist

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    Measured with 7 statements from the MAPPIN'SDM Therapist, measured on a 5-point scale

  8. Preferred decision-making role

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    Measured with the Control Preference Scale, comprising a question with 5 statements about roles, corresponding to active role, collaborative role and passive role

  9. Illness perception

    Time frame: Baseline, 8 weeks

    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

  10. Pain self-efficacy

    Time frame: Baseline, 8 weeks

    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.

  11. Pain catastrophizing

    Time frame: Baseline, 8 weeks

    Measured with one question about consern about pain, measured on a 0 (not at all) to 4 (all the time) scale.

  12. Pain intensity

    Time frame: Baseline, 8 weeks

    Measured with four questions from the Brief Pain Inventory, assessed on numeric rating scales from 0 (no pain) to 10 (worst possible pain).

  13. Pain intensity now

    Time frame: Baseline, 4 weeks (only intervention group), 8 weeks, 1 and 2 years

    Measured with one question about pain intensity now on a numeric rating scale from 0 (no pain) to 10 (worst possible pain).

  14. Disease activity

    Time frame: Baseline, 8 weeks, 1 and 2 years

    Measured with a numeric rating scale from 0 (no disease activity) to 10 (worst disease activity)

  15. Fatigue

    Time frame: Baseline, 8 weeks, 1 and 2 years

    Measured on a numeric rating scale from 0 (no fatigue) to 10 (worst possible fatigue)

  16. Importance of treatment options

    Time frame: Baseline, 8 weeks

    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)

  17. Preferred treatment

    Time frame: Baseline, 8 weeks

    Measured with a question about if they prefer surgery or non-surgical treatment

  18. Health literacy

    Time frame: Baseline

    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

  19. Self-efficacy of digital solutions

    Time frame: Baseline

    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

  20. Previous treatment

    Time frame: Baseline

    Assessment of previous treatment, answered with yes/no on questions related to previous physiotherapy treatment, previous osteoarthritis school,

  21. Health problems impact on daily living

    Time frame: Baseline, 8 weeks, 1 and 2 years

    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)

  22. Decision regret

    Time frame: approx. 2-4 months after baseline (1 day after consultation (post consultation))

    Measured with item 2 from the Decision regret scale, answered on a 5-point scale from totally agree to totally disagree

  23. Use of pain medication

    Time frame: Baseline, 8 weeks, 1 and 2 years

    Assessed with an open-ended question about the use of pain medication last three months (type and dosage)

  24. Demographics

    Time frame: Baseline

    Measured with questions about gender, age, education level, working status, smoking, living arrangements, sosioeconomic status, and support

  25. Antropometrics

    Time frame: Baseline

    Measured as self-reported hight and weight

  26. Joint-spesific information

    Time frame: Baseline

    Measured with questions about most trouble some knee, duration of complaints, other joints with complaints

  27. Exercise level

    Time frame: Baseline, 8 weeks, 1 and 2 years

    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

  28. Comorbidities

    Time frame: Baseline

    Assessed with 15 questions about the presens of different diseases (yes/no)

  29. Usability of the app

    Time frame: 8 weeks (only intervention group)

    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

  30. Satisfaction with the app

    Time frame: 8 weeks (only the intervention group)

    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)

  31. Suitability of the app

    Time frame: 8 weeks (only the intervention group)

    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)

  32. Surgical treatment

    Time frame: 1 and 2 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anne Therese Tveter, PhD

CONTACT

[email protected]

+4791115550

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Acronym: OA-AID

Important dates

Study start
2025
Primary completion
2028
Study completion
2035
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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