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.
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
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
20
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.
Diakonhjemmet hospital
Oslo, Oslo County, Norway
Desirable feasibility level
Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility
Time frame: Through the 8 weeks intervention period
Patient-reported software usability
Considered feasible if the System Usability Scale score ≥68 on a 0-100 scale, 100= best score).
Time frame: At 8 weeks
Patient-reported experiences and perceived benefits
Experiences and perceived benefits collected in semi-structured interview
Time frame: 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
Time frame: 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).
Time frame: At baseline
Time use in the intervention period
Acceptable feasibility if \<10 minutes are spent in max 1/3 of the patients
Time frame: Through the 8 weeks intervention period
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.
Time frame: At baseline and at study completion (approx. 3 months after inclusion)
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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.
Time frame: At 8 weeks
Other patient reported outcomes
Available data at 8 weeks for ≥80% of the patients
Time frame: At 8 weeks
Recruitment rate
Acceptable recruitment rate is ≥50% of eligible patients
Time frame: At baseline
Patient dropout
Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.
Time frame: At 8 weeks
Trial logistics as assessed through interviews
Acceptable overall trial logistics as evaluated by the study group.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Through study completion (approx. 3 months after inclusion)