An interventional study of "Urika", a self-management application for patients with gout in Gout, sponsored by Diakonhjemmet Hospital. Completed at 1 site in Norway. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-12-11.
Sponsored by Diakonhjemmet Hospital · Not applicable, Interventional, and Health services research
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.
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.
232 studies on the registry are indexed under Gout; 45 are open to participants now.
This study's enrollment of 21 is below the median of 121 across 202 interventional studies indexed under Gout.
Browse Gout studies →Diakonhjemmet Hospital is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Desirable feasibility level
Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility.
Time frame: Through study completion, an average of 3 months
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
Time frame: Through study completion, an average of 3 months
Patient-reported software usability
Considered feasible if the System Usability Scale median score is ≥68 on a 0-100 scale, 100= best score
Time frame: At 3 months
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
Time frame: At 3 months
Patient and health professionals' training requirements
Measured by registering amount of time spent (minutes) on training
Time frame: Pre-baseline for health professionals and at baseline for patients
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.
Time frame: At 3 months
Integration of workflow for health professionals
Measured by registering time spent on screening and enrollment
Time frame: At screening and enrollment
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
Time frame: At 3 months
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.
Time frame: Through study completion, an average of 3 months
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.
Time frame: Through study completion, an average of 3 months
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.
Time frame: At 3 months
Acute gout flares
Number of acute gout flares
Time frame: At 3 months
Side-effects of urate lowering therapy
Number of side-effects registered in the app or by study nurse or study coordinator
Time frame: At 3 months
Adverse events
Number of adverse events (incl. serious adverse events) registered by study medical doctor, study nurse or study coordinator
Time frame: At 3 months
Patient satisfaction with the follow-up care
Measured by a single item with 5 response categories, ranging from very dissatisfied to very satisfied, higher scores mean higher satisfaction. Considered acceptable feasibility if \>=70% of the participants report to be satisfied or very satisfied.
Time frame: At 3 months
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.
Time frame: At baseline and 3 months
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.
Time frame: At 3 months
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.
Time frame: At 3 months
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.
Time frame: At 3 months
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
Time frame: At 3 months
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
Time frame: At 3 months
Sick leave and time off work
Considered acceptable feasibility if there is available data for ≥90% of participants using self-report
Time frame: At 3 months
Eligible patients per month
Number of eligible patients per month.
Time frame: At enrollment
Recruitment rate
Acceptable recruitment rate is ≥50% of eligible patients.
Time frame: After enrollment
Patient dropout
Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients.
Time frame: At 3 months
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.
Time frame: At 3 months
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.
Time frame: Through study completion, an average of 3 months
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.
Time frame: Through study completion, an average of 3 months
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.
Time frame: Through study completion, an average of 3 months
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.
Time frame: Through study completion, an average of 3 months
Patients' app use: flare registering
Count the number of flare registering. Considered acceptable feasibility if ≥10% of the participants register 1 flare.
Time frame: Through study completion, an average of 3 months
Potential risk and challenges
Incidence of hinders that could harm a successful clinical evaluation of the app in a large randomised, controlled trial.
Time frame: At 3 months
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Diakonhjemmet Hospital