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Not Yet RecruitingNCT07490522

The Remote Monitoring of Gout Feasibility Study in Primary Care

The Self-management App 'MinUrinsyregikt' for Patients With Gout. The ReMonit Gout Feasibility Study in Primary Care

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Diakonhjemmet Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this feasibility study is to determine the feasibility of a patient self-management app (MinUrinsyregikt) for patients with gout. The primary objectives of the study are: 1. To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up. 2. To determine the feasibility of conducting a future randomised controlled trial to test the effectiveness of the app for patients with gout in primary care. Participants will be asked to test the self-management app for 3 months. Data will be collected from the participants and their GPs.

Detailed description

The study is a single-group, decentralized feasibility study over 3 months with pre- and post-intervention measurements and data collections through the app. Patients and GPs will be recruited from primary care throughout Norway. 20-50 adults with a gout diagnosis, serum urate level \>360 μmol/L, and an indication for urate lowering therapy will be included in the study. The patients will receive self-management support from the 'MinUrinsyregikt'-app in addition to usual follow-up from their GP. The study coordinator will provide instructions on how to download and use the app. The patients will register the following information in the app: whether they have tophi, type of urate lowering medication and dose, medical adherence, flares, and the serum urate level from the monthly blood test. The app will provide information about the date for the next blood test, reminders for blood tests and medication, and advice to contact their GP if the urate level is too high. The GPs will be responsible for the medical follow-up of the patients and will not have access to information from the app. Data will be collected from participants through digital questionnaires at baseline. After 3 months participants and GPs will be asked to answer a digital questionnaire and be invited to participate in semi-structured interviews about their experiences with app-supported follow-up for gout.

Conditions

Interventions

TypeNameDescription
DEVICEPatient self-management app 'MinUrinsyregikt'The purpose of the 'MinUrinsyregikt' -app is to support self-management for patients with gout receiving urate lowering therapy. The content of the app reflects current treatment recommendations for gout. The app includes information videos and texts about gout and gout treatment, registration tools for gout flares, serum urate levels, and medication adherence. The app enables reminder alerts for medications and for blood sampling. After the monthly blood test of serum urate levels, the patients will register this value in the app and respond to two questions to validate the serum urate blood test value. The app will then provide a date for the next blood test and advice the patient to contact their GP if the serum urate level is over the treatment target.

Timeline

Start date
2026-04-01
Primary completion
2027-12-01
Completion
2027-12-01
First posted
2026-03-24
Last updated
2026-03-24

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT07490522. Inclusion in this directory is not an endorsement.