Health TrialsbyHealthPanel

The Remote Monitoring of Gout Feasibility Study in Primary Care

ConditionGout
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDiakonhjemmet Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Self-management appExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diakonhjemmet Hospital

Lead sponsor

The Dam Foundation

Collaborator

The Norwegian Rheumatism Association

Collaborator

Diakonhjemmet Hospital AS

Collaborator

REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases

Collaborator

Source ClinicalTrials.gov
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