The Remote Monitoring of Gout Feasibility Study

NCT ID: NCT06211322

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2024-10-11

Brief Summary

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In this feasibility trial, a digital follow-up treatment strategy with patient self-management app (Urika) and remote monitoring in specialist healthcare for patients with gout will be tested.

Detailed Description

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In this feasibility study various outcome measures will be assessed to determine whether the app (Urika) is viable, practical, and useful. The study will include assessments of technical, operational, clinical, and trial aspects of feasibility.

Conditions

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Gout

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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To determine the feasibility of a patient self-management application (Urika) in patients with gout.

The intended purpose of the app is to support self-management for patients with gout that initiate urate lowering therapy.

Group Type EXPERIMENTAL

"Urika", a self-management application for patients with gout

Intervention Type DEVICE

The self-management software application (Urika) will include information videos on gout and treatment, reminders of daily medication and blood tests, a built-in algorithm for medical dosage escalation, visualization and log of serum urate levels, motivational gamification, asynchronous chat function patient-health professionals, and a platform for remote monitoring by health professionals.

Interventions

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"Urika", a self-management application for patients with gout

The self-management software application (Urika) will include information videos on gout and treatment, reminders of daily medication and blood tests, a built-in algorithm for medical dosage escalation, visualization and log of serum urate levels, motivational gamification, asynchronous chat function patient-health professionals, and a platform for remote monitoring by health professionals.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant, non-nursing female \>18 years of age at screening
* Patients with a clinical diagnosis of gout
* Patients who fulfil the American College of Rheumatology (ACR)/EULAR classification criteria
* Serum urate level \>360 μmol/L at inclusion
* Having a smartphone/tablet

Exclusion Criteria

* Contraindication for urate lowering therapy
* Unstable medical conditions (e.g,, uncontrollable hypertension, impaired liver function); known stage 3b or higher chronic kidney disease (estimated glomerular filtration (eGFR) rate/creatinine clearance \<45 mL/min); severe infection or gastrointestinal bleed
* Major co-morbidities (e.g., malignancies, severe cardiovascular disease, severe diabetes mellitus, severe respiratory diseases)
* Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol difficult
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nina Osteras

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nina Østerås, Prof.

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet Hospital

Locations

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Diakonhjemmet Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2023054

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

23/02662

Identifier Type: -

Identifier Source: org_study_id