The Remote Monitoring of Gout Feasibility Study

NCT06211322 | Completed

• 2 other identifiers: 23/026622023054
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Desirable feasibility level

  Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility.

  Through study completion, an average of 3 months

Secondary Outcomes (31)

• App performance and functionality

  Through study completion, an average of 3 months

• Patient-reported software usability

  At 3 months

• Patient-reported experiences and perceived benefits with the app

  At 3 months

• Patient and health professionals' training requirements

  Pre-baseline for health professionals and at baseline for patients

• Patient-reported satisfaction with the app

  At 3 months

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Having a smartphone/tablet

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

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

• Nina Østerås, Prof.

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 18, 2024
• Study Start: February 27, 2024
• Primary Completion: September 26, 2024
• Study Completion: October 11, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

NO (1)