NCT06211322CompletedNot Applicable
The ReMonit Gout Feasibility Study
Diakonhjemmet Hospital2 sites in 1 country21 target enrollmentStarted: February 27, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Desirable feasibility level
Study Overview
Brief Summary
In this feasibility trial, a digital follow-up treatment strategy with patient self-management app (Urika) and remote monitoring in specialist healthcare for patients with gout will be tested.
Detailed Description
In this feasibility study various outcome measures will be assessed to determine whether the app (Urika) is viable, practical, and useful. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or non-pregnant, non-nursing female >18 years of age at screening
- •Patients with a clinical diagnosis of gout
- •Patients who fulfil the American College of Rheumatology (ACR)/EULAR classification criteria
- •Serum urate level >360 μmol/L at inclusion
- •Having a smartphone/tablet
Exclusion Criteria
- •Contraindication for urate lowering therapy
- •Unstable medical conditions (e.g,, uncontrollable hypertension, impaired liver function); known stage 3b or higher chronic kidney disease (estimated glomerular filtration (eGFR) rate/creatinine clearance <45 mL/min); severe infection or gastrointestinal bleed
- •Major co-morbidities (e.g., malignancies, severe cardiovascular disease, severe diabetes mellitus, severe respiratory diseases)
- •Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Arms & Interventions
To determine the feasibility of a patient self-management application (Urika) in patients with gout.
Experimental
The intended purpose of the app is to support self-management for patients with gout that initiate urate lowering therapy.
Intervention: "Urika", a self-management application for patients with gout (Device)
Outcomes
Primary Outcomes
Desirable feasibility level
Time Frame: Through study completion, an average of 3 months
Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility.
Secondary Outcomes
- App performance and functionality(Through study completion, an average of 3 months)
- Patient-reported software usability(At 3 months)
- Patient-reported experiences and perceived benefits with the app(At 3 months)
- Patient and health professionals' training requirements(Pre-baseline for health professionals and at baseline for patients)
- Patient-reported satisfaction with the app(At 3 months)
- Integration of workflow for health professionals(At screening and enrollment)
- Serum urate level(At 3 months)
- Patient-reported software functionality(Through study completion, an average of 3 months)
- Urate lowering therapy dose escalation(Through study completion, an average of 3 months)
- Patient-reported adherence to serum urate lowering therapy(At 3 months)
- Acute gout flares(At 3 months)
- Side-effects of urate lowering therapy(At 3 months)
- Adverse events(At 3 months)
- Patient satisfaction with the follow-up care(At 3 months)
- Knowledge of gout and recommended treatment(At baseline and 3 months)
- Pain related to gout(At 3 months)
- Health related quality of life(At 3 months)
- Activity limitations(At 3 months)
- Number of consultations in specialist or primary healthcare(At 3 months)
- Costs and time for traveling(At 3 months)
- Sick leave and time off work(At 3 months)
- Eligible patients per month(At enrollment)
- Recruitment rate(After enrollment)
- Patient dropout(At 3 months)
- Trial logistics(At 3 months)
- Patients' app use: videos watched(Through study completion, an average of 3 months)
- Patients' app use: registrations of daily medication adherence(Through study completion, an average of 3 months)
- Patients' app use: registration of serum urate levels(Through study completion, an average of 3 months)
- Patients' app use: chat messages(Through study completion, an average of 3 months)
- Patients' app use: flare registering(Through study completion, an average of 3 months)
- Potential risk and challenges(At 3 months)
Investigators
Nina Osteras
Professor
Diakonhjemmet Hospital
Study Sites (2)
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