The Remote Monitoring of Gout Feasibility Study in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient self-management app 'MinUrinsyregikt'.
- Who it may be relevant to
- Registry conditions: Gout. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Self-management App 'MinUrinsyregikt' for Patients With Gout. The ReMonit Gout Feasibility Study in Primary Care
Overview
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.
Interventions
- Device Patient 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 patient
Primary outcome measures
- Acceptable overall feasibility of the app based on a total evaluation of the secondary endpoints for technical and operational feasibility. [Time frame: 3 months]
- Acceptable overall trial feasibility based on the total evaluation of the secondary endpoints for trial feasibility. [Time frame: 3 months]
Secondary outcome measures (12)
- Technical feasibility: Patient-reported errors in app [Time frame: 3 months]
- Technical feasibility: Patient-reported software performance and functionality [Time frame: 3 months]
- Technical feasibility: Patient-reported software usability [Time frame: 3 months]
- Technical feasibility: Patient-reported satisfaction with the app [Time frame: 3 months]
- Technical feasibility: Patient-repoted benefits and disadvantages of the app [Time frame: 3 months]
- Operational feasibility: Patients' training requirements [Time frame: 3 months]
- Operational feasibility: GP and patient-reported barriers and facilitators of app-supported gout follow-up [Time frame: 3 months]
- Operational feasibility: Patient satisfaction with the follow-up care [Time frame: 3 months]
- Trial feasibility: Number of eligible patients per month and recruitment rate [Time frame: 3 months]
- Trial feasibility: Patient dropout [Time frame: 3 months]
- Trial feasibility: Patients' app use [Time frame: 3 months]
- Trial feasibility: Barriers and facilitators to study participation for patients and GPs [Time frame: 3 months]
Eligibility criteria
Patients are eligible to be included in the study only if all the following criteria apply:
- Adults ≥18 years of age at screening
- Patients with a clinical diagnosis of gout
- Serum urate level >360 µmol/L at inclusion
- Indication for urate lowering therapy assessed by medical doctor
- Having a smartphone/tablet
Patients are excluded from the study if any of the following criteria apply:
- Pregnant or breastfeeding
- Contraindication for urate lowering therapy
- Does not understand Norwegian language
- Major co-morbidities (e.g., malignancies, severe chronic kidney disease, severe mental disorders)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- Diakonhjemmet Hospital — Oslo
Identifiers
NCT: NCT07490522 · 966720 · 25/03734