The Remote Monitoring of Gout Feasibility Study

Gout Clinical Trial

— ReMonit Gout  

Official title:

The ReMonit Gout Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211322
• Other study ID #: 23/02662
• Secondary ID: 2023054
• Status: Recruiting
• Phase: N/A
• Start date: February 27, 2024
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: Diakonhjemmet Hospital
• Contact: Silje Søhus, MSc.
• Phone: +4722451500
• Email: silje.sohus[@]diakonsyk.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gout

Intervention

Device:
• "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.

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	App performance and functionality	Acceptable number of errors (=5 errors per participant) in the performance and functionality experienced by the patients and project group members	Through study completion, an average of 3 months
Secondary	Patient-reported software usability	Considered feasible if the System Usability Scale median score is =68 on a 0-100 scale, 100= best score	At 3 months
Secondary	Patient-reported experiences and perceived benefits with the app	Open responses will be collected in semi-structured interview. No scales or instruments will be used	At 3 months
Secondary	Patient and health professionals' training requirements	Measured by registering amount of time spent (minutes) on training	Pre-baseline for health professionals and at baseline for patients
Secondary	Patient-reported satisfaction with the app	Measured by a numeric rating scale (NRS) 0-10, higher scores mean better outcome. Acceptable feasibility if >=70% of the participants report score >=5, otherwise considered not acceptable feasibility.	At 3 months
Secondary	Integration of workflow for health professionals	Measured by registering time spent on screening and enrollment	At screening and enrollment
Secondary	Serum urate level	Considered feasible if there is available data on serum urate levels for =90% of patients for calculation of mean levels and proportion with low serum urate level	At 3 months
Secondary	Patient-reported software functionality	Total number of reported errors related to the software functionality (e.g., downloading, login, registration of medication, reminders, access to videos, medication adherence, registration of blood test results, urate level graph, blood test history, chat, request new prescription). Considered acceptable feasibility if the number of errors are =5 per patient in the performance and functionality experienced by the patients and project group members.	Through study completion, an average of 3 months
Secondary	Urate lowering therapy dose escalation	Considered feasible if patient-reported data and the medication history in the app monitored in the platform for health personnel is available for =90% of patients.	Through study completion, an average of 3 months
Secondary	Patient-reported adherence to serum urate lowering therapy	Patient-reported Medication Adherence Report Scale (MARS-5), score range 5-25, higher scores mean better adherence. Considered acceptable feasibility if >=90% of the patients complete the instrument.	At 3 months
Secondary	Acute gout flares	Number of acute gout flares	At 3 months
Secondary	Side-effects of urate lowering therapy	Number of side-effects registered in the app or by study nurse or study coordinator	At 3 months
Secondary	Adverse events	Number of adverse events (incl. serious adverse events) registered by study medical doctor, study nurse or study coordinator	At 3 months
Secondary	Patient satisfaction with the follow-up care	Measured by a numeric rating scale (NRS) 0-10, higher scores mean better outcome. Considered acceptable feasibility if >=70% of the participants score >=5 on the NRS.	At 3 months
Secondary	Knowledge of gout and recommended treatment	Measured by the Gout Knowledge Questionnaire, 0-10, higher scores mean better outcome. Considered acceptable feasibility if there is available total score data for >=90% of the patients.	At baseline and 3 months
Secondary	Pain related to gout	Measured by a numeric rating scale (NRS) 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.	At 3 months
Secondary	Health related quality of life	Measured by the Euro Quality of Life 5 Dimensions 5 Levels, each item is scored 1-5, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.	At 3 months
Secondary	Activity limitations	Measured by Work Productivity and Activity Impairment (WPAI) item no.6, 0-10, lower scores mean better outcome. Considered acceptable feasibility if there is available data for >=90% of the participants.	At 3 months
Secondary	Number of consultations in specialist or primary healthcare	Considered acceptable feasibility if there is available data for =90% of patients on patient-reported visits in specialist or primary healthcare	At 3 months
Secondary	Costs and time for traveling	Considered acceptable feasibility if there is available data for =90% of patients on patient-reported time for travelling to the hospital	At 3 months
Secondary	Sick leave and time off work	Considered acceptable feasibility if there is available data for =90% of participants using self-report	At 3 months
Secondary	Eligible patients per month	Number of eligible patients per month.	At enrollment
Secondary	Recruitment rate	Acceptable recruitment rate is =50% of eligible patients.	After enrollment
Secondary	Patient dropout	Number of patients that withdraw from the study. Acceptable withdrawal rate is =20% of included patients.	At 3 months
Secondary	Trial logistics	Acceptable overall trial logistics (Identification, screening, recruitment, patient training, data collections, monitoring blood test results, renewal of prescriptions) evaluated as Yes vs. No by the study group.	At 3 months
Secondary	Patients' app use: videos watched	Count the number of videos watched per participant. Considered acceptable feasibility if =70% of the participants have watched at least 1 video.	Through study completion, an average of 3 months
Secondary	Patients' app use: registrations of daily medication adherence	Count the number of registrations of daily medication adherence. Considered acceptable feasibility if =70% of the participants have registered at least 1 adherence.	Through study completion, an average of 3 months
Secondary	Patients' app use: registration of serum urate levels	Count the number of registered serum urate levels. Considered acceptable feasibility if =90% of the patients register their serum urate level monthly.	Through study completion, an average of 3 months
Secondary	Patients' app use: chat messages	Count the number of chat messages. Considered acceptable feasibility if =70% of the participants register at least 1 chat message.	Through study completion, an average of 3 months
Secondary	Patients' app use: flare registering	Count the number of flare registering. Considered acceptable feasibility if =10% of the participants register 1 flare.	Through study completion, an average of 3 months
Secondary	Potential risk and challenges	Incidence of hinders that could harm a successful clinical evaluation of the app in a large randomised, controlled trial.	At 3 months