Clinical trial NCT06656845: Feasibility of a Self-management App for People With Knee Osteoarthritis (OA-AID Feasibility Study)
Official title: Feasibility of a Self-management App for People With Knee Osteoarthritis (OA-AID Feasibility Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: Osteoarthritis
E-health
Remote care
Feasibility
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Desirable feasibility level
timeFrame: Through the 8 weeks intervention period
Secondary outcomes:
measure: Patient-reported software usability
timeFrame: At 8 weeks
measure: Patient-reported experiences and perceived benefits
timeFrame: At 8 weeks
measure: Patient-reported satisfaction with the app
timeFrame: At 8 weeks
measure: Integration of workflow for health professionals
timeFrame: At baseline
measure: Time use in the intervention period
timeFrame: Through the 8 weeks intervention period
measure: Primary clinical outcome
timeFrame: At baseline and at study completion (approx. 3 months after inclusion)
measure: Patient satisfaction with the intervention at 8 weeks
timeFrame: At 8 weeks
measure: Other patient reported outcomes
timeFrame: At 8 weeks
measure: Recruitment rate
timeFrame: At baseline
measure: Patient dropout
timeFrame: At 8 weeks
measure: Trial logistics as assessed through interviews
timeFrame: At study completion (approx. 3 months after inclusion)
measure: Patients' app use
timeFrame: Through study completion (approx. 3 months after inclusion)
measure: Potential risk and challenges as assessed through interviews
timeFrame: At study completion (approx. 3 months after inclusion)
measure: Software performance and functionality
timeFrame: Through study completion (approx. 3 months after inclusion)
measure: Other patient reported outcomes
timeFrame: Through study completion (approx. 3 months after inclusion)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Anne Therese Tveter, PhD
role: PRINCIPAL_INVESTIGATOR
References: