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Clinical Trials/NCT06656845
NCT06656845
Completed
Not Applicable

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

Diakonhjemmet Hospital1 site in 1 country20 target enrollmentJanuary 5, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Diakonhjemmet Hospital
Enrollment
20
Locations
1
Primary Endpoint
Desirable feasibility level
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2025
End Date
May 31, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Diakonhjemmet Hospital
Responsible Party
Principal Investigator
Principal Investigator

Anne Therese Tveter

Professor

Diakonhjemmet Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Patient-reported software usability(At 8 weeks)
  • Patient-reported experiences and perceived benefits(At 8 weeks)
  • Integration of workflow for health professionals(At baseline)
  • Patient satisfaction with the intervention at 8 weeks(At 8 weeks)
  • Other patient reported outcomes(Through study completion (approx. 3 months after inclusion))
  • Patient-reported satisfaction with the app(At 8 weeks)
  • Time use in the intervention period(Through the 8 weeks intervention period)
  • Primary clinical outcome(At baseline and at study completion (approx. 3 months after inclusion))
  • Recruitment rate(At baseline)
  • Patient dropout(At 8 weeks)
  • Trial logistics as assessed through interviews(At study completion (approx. 3 months after inclusion))
  • Patients' app use(Through study completion (approx. 3 months after inclusion))
  • Potential risk and challenges as assessed through interviews(At study completion (approx. 3 months after inclusion))
  • Software performance and functionality(Through study completion (approx. 3 months after inclusion))

Study Sites (1)

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