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

Not Applicable

Recruiting

• Conditions: Knee Osteoarthristis

• Registration Number: NCT06656845
• Lead Sponsor: Diakonhjemmet Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-22
• Study First Posted: 2024-10-24
• Study Start: 2025-01-05
• Status Verified: 2025-05
• Primary Completion: 2025-05-07
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Desirable feasibility level	Through the 8 weeks intervention period	Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility

Secondary Outcome Measures

Name	Time	Method
Patient-reported software usability	At 8 weeks	Considered feasible if the System Usability Scale score ≥68 on a 0-100 scale, 100= best score).
Patient-reported experiences and perceived benefits	At 8 weeks	Experiences and perceived benefits collected in semi-structured interview
Integration of workflow for health professionals	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).
Patient satisfaction with the intervention at 8 weeks	At 8 weeks	Considered feasible if 70% with score ≥5 on a numeric rating scale (NRS) 0-10 on patient satisfaction with intervention.
Other patient reported outcomes	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
Patient-reported satisfaction with the app	At 8 weeks	Measured by a numeric rating scale (NRS) 0-10, higher scores indicate better outcome. Acceptable feasibility 70% with score ≥5
Time use in the intervention period	Through the 8 weeks intervention period	Acceptable feasibility if \<10 minutes are spent in max 1/3 of the patients
Primary clinical outcome	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.
Recruitment rate	At baseline	Acceptable recruitment rate is ≥50% of eligible patients
Patient dropout	At 8 weeks	Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.
Trial logistics as assessed through interviews	At study completion (approx. 3 months after inclusion)	Acceptable overall trial logistics as evaluated by the study group.
Patients' app use	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.
Potential risk and challenges as assessed through interviews	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.
Software performance and functionality	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

Trial Locations

Locations (1)

Diakonhjemmet hospital; 🇳🇴 Oslo, Norway