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| ID | Type | Description | Link |
|---|---|---|---|
| 2023054 | Other Grant/Funding Number | South-Eastern Norway Health Authority |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient-reported software usability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Østerås, Prof. | Diakonhjemmet Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diakonhjemmet Hospital | Oslo | 0319 | Norway |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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|
Considered feasible if the System Usability Scale median score is ≥68 on a 0-100 scale, 100= best score |
| 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 | At 3 months |
| 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 |
| 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 |
| Integration of workflow for health professionals | Measured by registering time spent on screening and enrollment | 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 | 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. | 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. | 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. | At 3 months |
| Acute gout flares | Number of acute gout flares | At 3 months |
| Side-effects of urate lowering therapy | Number of side-effects registered in the app or by study nurse or study coordinator | At 3 months |
| Adverse events | Number of adverse events (incl. serious adverse events) registered by study medical doctor, study nurse or study coordinator | 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. | 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. | 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. | 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. | 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. | 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 | 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 | At 3 months |
| Sick leave and time off work | Considered acceptable feasibility if there is available data for ≥90% of participants using self-report | At 3 months |
| Eligible patients per month | Number of eligible patients per month. | At enrollment |
| Recruitment rate | Acceptable recruitment rate is ≥50% of eligible patients. | After enrollment |
| Patient dropout | Number of patients that withdraw from the study. Acceptable withdrawal rate is ≤20% of included patients. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At 3 months |
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |