Gout
Conditions
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.
Interventions
DEVICEUrika, 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.
Sponsors
Diakonhjemmet Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Desirable feasibility level | Through study completion, an average of 3 months | Acceptable overall feasibility of the app with ≥70% of the secondary endpoints indicating feasibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of gout and recommended treatment | At baseline and 3 months | 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. |
| Pain related to gout | At 3 months | 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. |
| Health related quality of life | At 3 months | 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. |
| Activity limitations | At 3 months | 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. |
| Number of consultations in specialist or primary healthcare | At 3 months | Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported visits in specialist or primary healthcare |
| App performance and functionality | Through study completion, an average of 3 months | Acceptable number of errors (≤5 errors per participant) in the performance and functionality experienced by the patients and project group members |
| Patient-reported software usability | At 3 months | Considered feasible if the System Usability Scale median score is ≥68 on a 0-100 scale, 100= best score |
| Patient-reported experiences and perceived benefits with the app | At 3 months | Open responses will be collected in semi-structured interview. No scales or instruments will be used |
| Patient and health professionals' training requirements | Pre-baseline for health professionals and at baseline for patients | Measured by registering amount of time spent (minutes) on training |
| Patient-reported satisfaction with the app | At 3 months | 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. |
| Integration of workflow for health professionals | At screening and enrollment | Measured by registering time spent on screening and enrollment |
| Serum urate level | At 3 months | 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 |
| Patient-reported software functionality | Through study completion, an average of 3 months | 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. |
| Urate lowering therapy dose escalation | Through study completion, an average of 3 months | 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. |
| Patient-reported adherence to serum urate lowering therapy | At 3 months | 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. |
| Patient satisfaction with the follow-up care | At 3 months | 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. |
| Side-effects of urate lowering therapy | At 3 months | Number of side-effects registered in the app or by study nurse or study coordinator |
| Adverse events | At 3 months | Number of adverse events (incl. serious adverse events) registered by study medical doctor, study nurse or study coordinator |
| Costs and time for traveling | At 3 months | Considered acceptable feasibility if there is available data for ≥90% of patients on patient-reported time for travelling to the hospital |
| Sick leave and time off work | At 3 months | Considered acceptable feasibility if there is available data for ≥90% of participants using self-report |
| Eligible patients per month | At enrollment | Number of eligible patients per month. |
| Recruitment rate | After enrollment | Acceptable recruitment rate is ≥50% of eligible patients. |
| Patient dropout | At 3 months | Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients. |
| Trial logistics | At 3 months | 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. |
| Patients' app use: videos watched | Through study completion, an average of 3 months | Count the number of videos watched per participant. Considered acceptable feasibility if ≥70% of the participants have watched at least 1 video. |
| Patients' app use: registrations of daily medication adherence | Through study completion, an average of 3 months | Count the number of registrations of daily medication adherence. Considered acceptable feasibility if ≥70% of the participants have registered at least 1 adherence. |
| Patients' app use: registration of serum urate levels | Through study completion, an average of 3 months | Count the number of registered serum urate levels. Considered acceptable feasibility if ≥90% of the patients register their serum urate level monthly. |
| Patients' app use: chat messages | Through study completion, an average of 3 months | Count the number of chat messages. Considered acceptable feasibility if ≥70% of the participants register at least 1 chat message. |
| Patients' app use: flare registering | Through study completion, an average of 3 months | Count the number of flare registering. Considered acceptable feasibility if ≥10% of the participants register 1 flare. |
| Potential risk and challenges | At 3 months | Incidence of hinders that could harm a successful clinical evaluation of the app in a large randomised, controlled trial. |
| Acute gout flares | At 3 months | Number of acute gout flares |
Countries
Norway
Outcome results
None listed