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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Device: Genus, a self-management app for patients with knee osteoarthritis

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0319
    • Diakonhjemmet Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: To determine the feasibility of a patient self-management app in patients with knee osteoarthritis; The intended purpose of the app (Genus) is to provide information on osteoarthritis and recommended treatment for people with knee OA.	Device: Genus, a self-management app for patients with knee osteoarthritis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Desirable feasibility level	Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility	Through the 8 weeks intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported software usability	Considered feasible if the System Usability Scale score ≥68 on a 0-100 scale, 100= best score).	At 8 weeks
Patient-reported experiences and perceived benefits	Experiences and perceived benefits collected in semi-structured interview	At 8 weeks
Patient-reported satisfaction with the app	Measured by a numeric rating scale (NRS) 0-10, higher scores indicate better outcome. Acceptable feasibility 70% with score ≥5	At 8 weeks
Integration of workflow for health professionals	Measured by registering time of time use: acceptable feasibility if <30 minutes is spent on screening and enrolling (consent, baseline questionnaire, and downloading).	At baseline
Time use in the intervention period	Acceptable feasibility if <10 minutes are spent in max 1/3 of the patients	Through the 8 weeks intervention period
Patient satisfaction with the intervention at 8 weeks	Considered feasible if 70% with score ≥5 on a numeric rating scale (NRS) 0-10 on patient satisfaction with intervention.	At 8 weeks
Other patient reported outcomes	Available data at 8 weeks for ≥80% of the patients	At 8 weeks
Recruitment rate	Acceptable recruitment rate is ≥50% of eligible patients	At baseline
Patient dropout	Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.	At 8 weeks
Trial logistics as assessed through interviews	Acceptable overall trial logistics as evaluated by the study group.	At study completion (approx. 3 months after inclusion)
Patients' app use	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.	Through study completion (approx. 3 months after inclusion)
Potential risk and challenges as assessed through interviews	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.	At study completion (approx. 3 months after inclusion)
Software performance and functionality	Acceptable number of errors (≤3 errors per patient) in the performance and functionality experienced by the patients and project group members	Through study completion (approx. 3 months after inclusion)
Other patient reported outcomes	Available data on other patient reported outcomes at pre- and post-consultation questionnaires for ≥80% of the patients	Through study completion (approx. 3 months after inclusion)
Primary clinical outcome	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.	At baseline and at study completion (approx. 3 months after inclusion)

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Investigators: Principal Investigator: Anne Therese Tveter, PhD, Diakonhjemmet Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Actual): May 7, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Osteoarthritis; Feasibility; E-health; Remote care
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 786516

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No