Clinical trial NCT06211322: The Remote Monitoring of Gout Feasibility Study
Official title: The ReMonit Gout Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gout
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 21
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Desirable feasibility level
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: App performance and functionality
timeFrame: Through study completion, an average of 3 months
measure: Patient-reported software usability
timeFrame: At 3 months
measure: Patient-reported experiences and perceived benefits with the app
timeFrame: At 3 months
measure: Patient and health professionals' training requirements
timeFrame: Pre-baseline for health professionals and at baseline for patients
measure: Patient-reported satisfaction with the app
timeFrame: At 3 months
measure: Integration of workflow for health professionals
timeFrame: At screening and enrollment
measure: Serum urate level
timeFrame: At 3 months
measure: Patient-reported software functionality
timeFrame: Through study completion, an average of 3 months
measure: Urate lowering therapy dose escalation
timeFrame: Through study completion, an average of 3 months
measure: Patient-reported adherence to serum urate lowering therapy
timeFrame: At 3 months
measure: Acute gout flares
timeFrame: At 3 months
measure: Side-effects of urate lowering therapy
timeFrame: At 3 months
measure: Adverse events
timeFrame: At 3 months
measure: Patient satisfaction with the follow-up care
timeFrame: At 3 months
measure: Knowledge of gout and recommended treatment
timeFrame: At baseline and 3 months
measure: Pain related to gout
timeFrame: At 3 months
measure: Health related quality of life
timeFrame: At 3 months
measure: Activity limitations
timeFrame: At 3 months
measure: Number of consultations in specialist or primary healthcare
timeFrame: At 3 months
measure: Costs and time for traveling
timeFrame: At 3 months
measure: Sick leave and time off work
timeFrame: At 3 months
measure: Eligible patients per month
timeFrame: At enrollment
measure: Recruitment rate
timeFrame: After enrollment
measure: Patient dropout
timeFrame: At 3 months
measure: Trial logistics
timeFrame: At 3 months
measure: Patients' app use: videos watched
timeFrame: Through study completion, an average of 3 months
measure: Patients' app use: registrations of daily medication adherence
timeFrame: Through study completion, an average of 3 months
measure: Patients' app use: registration of serum urate levels
timeFrame: Through study completion, an average of 3 months
measure: Patients' app use: chat messages
timeFrame: Through study completion, an average of 3 months
measure: Patients' app use: flare registering
timeFrame: Through study completion, an average of 3 months
measure: Potential risk and challenges
timeFrame: At 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Nina Østerås, Prof.
role: PRINCIPAL_INVESTIGATOR
References: