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Completed

NCT Number: NCT06656845

Feasibility of a Self-management App for People With Knee Osteoarthritis (OA-AID Feasibility Study)

In this feasibility trial, an 8-week digital intervention including remote monitoring in patients with knee osteoarthritis (OA) will be tested. The app will provide information on osteoarthritis and recommended treatment for people with knee OA.

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Key information

Conditions

Knee Osteoarthristis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diakonhjemmet hospital

Oslo, 0319, Norway

About this study

In this feasibility study various outcome measures will be assessed to determine whether the app (Genus) is viable, practical, and useful.

The study will test the feasibility of an 8-week digital intervention including remote monitoring prior to consultation in specialist healthcare. The app consist of information on osteoarthritis and recommended treatment for people with knee OA. A total of 20 patients referred to Diakonhjemmet Hospital due to knee OA will be recruited to the study. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility. Data will be collected through digital questionnaires (through the app or Nettskjema), through interviews and from medical records. Primary outcome is the feasibility of the app after 8 weeks. Additionally, the feasibility of the study process until consultation in specialist healthcare will be assessed.

The aim of the app is to improve patients' health literacy and enhance the shared decision-making process between patient and healthcare provider at the consultation in specialist healthcare.

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 of age
  • Referred to specialist healthcare for knee OA management

Exclusion criteria

  • Received joint replacement or are under consideration for revision in the referred joint
  • Have uncontrolled serious comorbidities
  • Have cognitive dysfunction
  • Are seeking care for trauma conditions or psoriatic/rheumatoid arthritis
  • Unable to understand Norwegian
  • Do not have a smartphone

Treatment and study plan

Genus, a self-management app for patients with knee osteoarthritis

Device

The self-management app (Genus) will include weekly reminders with information videos on knee osteoarthritis and treatment options, exercise videos, quizzes, questionnaires, and a platform for remote monitoring by health professionals.

Primary outcomes

  1. Desirable feasibility level

    Time frame: Through the 8 weeks intervention period

    Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility

Secondary outcomes

  1. Patient-reported software usability

    Time frame: At 8 weeks

    Considered feasible if the System Usability Scale score ≥68 on a 0-100 scale, 100= best score).

  2. Patient-reported experiences and perceived benefits

    Time frame: At 8 weeks

    Experiences and perceived benefits collected in semi-structured interview

  3. Patient-reported satisfaction with the app

    Time frame: At 8 weeks

    Measured by a numeric rating scale (NRS) 0-10, higher scores indicate better outcome. Acceptable feasibility 70% with score ≥5

  4. Integration of workflow for health professionals

    Time frame: At baseline

    Measured by registering time of time use: acceptable feasibility if <30 minutes is spent on screening and enrolling (consent, baseline questionnaire, and downloading).

  5. Time use in the intervention period

    Time frame: Through the 8 weeks intervention period

    Acceptable feasibility if <10 minutes are spent in max 1/3 of the patients

  6. Primary clinical outcome

    Time frame: At baseline and at study completion (approx. 3 months after inclusion)

    Available data on total score in the Knee Osteoarthritis Knowledge Scale (KOAKS, scored on a scale from 11-55) at baseline and after intervention for ≥80% of patients.

  7. Patient satisfaction with the intervention at 8 weeks

    Time frame: At 8 weeks

    Considered feasible if 70% with score ≥5 on a numeric rating scale (NRS) 0-10 on patient satisfaction with intervention.

  8. Other patient reported outcomes

    Time frame: At 8 weeks

    Available data at 8 weeks for ≥80% of the patients

  9. Recruitment rate

    Time frame: At baseline

    Acceptable recruitment rate is ≥50% of eligible patients

  10. Patient dropout

    Time frame: At 8 weeks

    Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.

  11. Trial logistics as assessed through interviews

    Time frame: At study completion (approx. 3 months after inclusion)

    Acceptable overall trial logistics as evaluated by the study group.

  12. Patients' app use

    Time frame: Through study completion (approx. 3 months after inclusion)

    Acceptable app use includes that ≥50% of the patients watch ≥80% of the videos (16 videos), ≥50% of the patients has exercised1 or more days, ≥50% have completed at least 1 quiz.

  13. Potential risk and challenges as assessed through interviews

    Time frame: At study completion (approx. 3 months after inclusion)

    Identify potential risk and challenges that could hinder a successful clinical evaluation of the app in a large randomised, controlled trial: Acceptable overall potential risk and challenges as evaluated by the study group at end of study.

  14. Software performance and functionality

    Time frame: Through study completion (approx. 3 months after inclusion)

    Acceptable number of errors (≤3 errors per patient) in the performance and functionality experienced by the patients and project group members

  15. Other patient reported outcomes

    Time frame: Through study completion (approx. 3 months after inclusion)

    Available data on other patient reported outcomes at pre- and post-consultation questionnaires for ≥80% of the patients

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 24, 2024
Registry last updated
Aug 13, 2025

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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