An interventional study of Patient self-management app 'MinUrinsyregikt' in Gout, sponsored by Diakonhjemmet Hospital. Recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Treatment
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:
Participants will be asked to test the self-management app for 3 months. Data will be collected from the participants and their GPs.
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.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 50 is below the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients are eligible to be included in the study only if all the following criteria apply:
Patients are excluded from the study if any of the following criteria apply:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients will receive access to the self-management application 'MinUrinsyregikt' in addition to usual follow-up from their GP.
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 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.
Acceptable overall feasibility of the app based on a total evaluation of the secondary endpoints for technical and operational feasibility.
Feasibility criteria: * No serious and irreversible errors in app * Mean System Usability Scale score ≥68 * 70% with score ≥5 on a numeric rating scale (0-10) on patient satisfaction with the app * No serious and irreversible barriers to app-supported follow up experienced by patients or GPs * No other serious and irreversible problems with the app
Time frame: 3 months
Acceptable overall trial feasibility based on the total evaluation of the secondary endpoints for trial feasibility.
Feasibility criteria: * Recruitment rate ≥50% of eligible patients * Withdrawal rate ≤20% of included patients * ≥90% of the patients register their sUA level in the app throughout the study * ≥90% of the patients answer baseline and 3 months questionnaires * No serious and irreversible risks or challenges that could hinder a successful clinical evaluation of the app in a large randomised controlled trial
Time frame: 3 months
Technical feasibility: Patient-reported errors in app
Number and type of technical errors in app reported by patients through the app and in questionnares at 3 months.
Time frame: 3 months
Technical feasibility: Patient-reported software performance and functionality
Patient experiences of app performance, functionality and ease of use. From semi-structured interviews.
Time frame: 3 months
Technical feasibility: Patient-reported software usability
Patient reported software usability, measured with The System Usability Scale (SUS), sum score 0-40 converted into 0-100, 100 = best score. From questionnaire at 3 months.
Time frame: 3 months
Technical feasibility: Patient-reported satisfaction with the app
Patient satisfaction with the app, measured with one item rated on a 0-10 numeric rating scale, ranging from 'very dissatisfied' (0) to 'very satisfied' (10), from questionnaire at 3 months.
Time frame: 3 months
Technical feasibility: Patient-repoted benefits and disadvantages of the app
Patients perceived benefits and disadvantages with the app collected from semi-structured interviews.
Time frame: 3 months
Operational feasibility: Patients' training requirements
Patient evaluation of the demo films and instruction manual. From semi-structured interviews.
Time frame: 3 months
Operational feasibility: GP and patient-reported barriers and facilitators of app-supported gout follow-up
Barriers and facilitators of app-supported gout follow-up experienced by patients and GPs. From semi-structured interviews and questionnaires at 3 months.
Time frame: 3 months
Operational feasibility: Patient satisfaction with the follow-up care
Participant satisfaction with the care, measured by one item from The Nordic Patient Experiences Questionnaire, with five point response options ranging from "Very satisfied" to "Very dissatisfied" from questionnaire at 3 months.
Time frame: 3 months
Trial feasibility: Number of eligible patients per month and recruitment rate
Number of patients screened, number of eligible patients, and the number of consenting patients every month, including information about how the patient was recruited. From identification and recruitment logs completed during the recruitment period and questionnaires at 3 months.
Time frame: 3 months
Trial feasibility: Patient dropout
Number of patients that withdraw from the study, reasons for dropout (if provided). From logs completed during the study period.
Time frame: 3 months
Trial feasibility: Patients' app use
Number of videos watched, registration of serum urate levels, medication adherence and flares in the app. From back-end data from the app and semi-structured interviews with patients.
Time frame: 3 months
Trial feasibility: Barriers and facilitators to study participation for patients and GPs
Barriers and facilitators for study participation experienced by patients and GPs, from semi-structured interviews.
Time frame: 3 months
Trial feasibility: Provision of blood-test results from GPs
Number of GPs providing blood test results and number of missing blood-test results from GPs, from questionnaires at 3 months.
Time frame: 3 months
Trial Feasibility: Serum urate level registrations in the app
Number of correct, incorrect and missing serum urate level registrations in the app. Urate level registrations from app and urate levels from blood tests provided by GPs at 3 months.
Time frame: 3 months
Trial feasibility: Patients' response to questionnaires
Response-rate to baseline questionnaire. Response-rate to 3-month questionnaire.
Time frame: 3 months
Trial feasibility: Adverse events
The number of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE). From questionnaires at 3-months to patients and GPs.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Diakonhjemmet Hospital