The Remote Monitoring of Gout Feasibility Study in Primary Care

NCT07490522 | Recruiting

• 2 other identifiers: 96672025/03734
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up.
2. 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.

Conditions

Gout

Keywords

Gout; Feasibility study; E-health; Primary care; Digital health; Urate-lowering Therapy (ULT)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  3 months

Secondary Outcomes (16)

• Technical feasibility: Patient-reported errors in app

  3 months

• Technical feasibility: Patient-reported software performance and functionality

  3 months

• Technical feasibility: Patient-reported software usability

  3 months

• Technical feasibility: Patient-reported satisfaction with the app

  3 months

• Technical feasibility: Patient-repoted benefits and disadvantages of the app

  3 months

Study Arms (1)

Self-management app

EXPERIMENTAL

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'

Interventions

Patient self-management app 'MinUrinsyregikt' DEVICE

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.

Self-management app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Dam Foundation: collaborator
• Diakonhjemmet Hospital AS: collaborator
• Diakonhjemmet Hospital: lead
• The Norwegian Rheumatism Association: collaborator
• REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases: collaborator

Study Sites (1)

Diakonhjemmet Hospital

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Fiona Aanesen

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Aanesen, PhD

CONTACT

+47 22451500; fiona.aanesen@diakonsyk.no

Silje Søhus

CONTACT

silje.sohus@diakonsyk.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral fellow

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)