The ReMonit Gout Feasibility Study

Diakonhjemmet Hospital1 site in 1 country21 target enrollmentFebruary 27, 2024

ConditionsGout

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gout
Sponsor: Diakonhjemmet Hospital
Enrollment: 21
Locations: 1
Primary Endpoint: Desirable feasibility level
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 27, 2024

End Date

October 11, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Diakonhjemmet Hospital

Responsible Party

Principal Investigator

Nina Osteras

Professor

Diakonhjemmet Hospital

Eligibility Criteria

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

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)