Knee Osteoarthristis
Conditions
Keywords
Osteoarthritis, E-health, Remote care, Feasibility
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.
Interventions
DEVICEGenus, 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.
Sponsors
Diakonhjemmet Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desirable feasibility level | Through the 8 weeks intervention period | Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported experiences and perceived benefits | At 8 weeks | Experiences and perceived benefits collected in semi-structured interview |
| 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 |
| 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). |
| 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. |
| 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. |
| Patient-reported software usability | At 8 weeks | Considered feasible if the System Usability Scale score ≥68 on a 0-100 scale, 100= best score). |
| 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 |
| Other patient reported outcomes | At 8 weeks | Available data at 8 weeks for ≥80% of the patients |
Countries
Norway
Outcome results
None listed