Gout
Conditions
Keywords
Gout, Feasibility study, E-health, Primary care, Digital health, Urate-lowering Therapy (ULT)
Brief summary
The goal of this feasibility study is to determine the feasibility of a patient self-management app (MinUrinsyregikt) for patients with gout. The primary objectives of the study are: 1. To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up. 2. To determine the feasibility of conducting a future randomised controlled trial to test the effectiveness of the app for patients with gout in primary care. Participants will be asked to test the self-management app for 3 months. Data will be collected from the participants and their GPs.
Detailed description
The study is a single-group, decentralized feasibility study over 3 months with pre- and post-intervention measurements and data collections through the app. Patients and GPs will be recruited from primary care throughout Norway. 20-50 adults with a gout diagnosis, serum urate level \>360 μmol/L, and an indication for urate lowering therapy will be included in the study. The patients will receive self-management support from the 'MinUrinsyregikt'-app in addition to usual follow-up from their GP. The study coordinator will provide instructions on how to download and use the app. The patients will register the following information in the app: whether they have tophi, type of urate lowering medication and dose, medical adherence, flares, and the serum urate level from the monthly blood test. The app will provide information about the date for the next blood test, reminders for blood tests and medication, and advice to contact their GP if the urate level is too high. The GPs will be responsible for the medical follow-up of the patients and will not have access to information from the app. Data will be collected from participants through digital questionnaires at baseline. After 3 months participants and GPs will be asked to answer a digital questionnaire and be invited to participate in semi-structured interviews about their experiences with app-supported follow-up for gout.
Interventions
DEVICEPatient self-management app 'MinUrinsyregikt'
The purpose of the 'MinUrinsyregikt' -app is to support self-management for patients with gout receiving urate lowering therapy. The content of the app reflects current treatment recommendations for gout. The app includes information videos and texts about gout and gout treatment, registration tools for gout flares, serum urate levels, and medication adherence. The app enables reminder alerts for medications and for blood sampling. After the monthly blood test of serum urate levels, the patients will register this value in the app and respond to two questions to validate the serum urate blood test value. The app will then provide a date for the next blood test and advice the patient to contact their GP if the serum urate level is over the treatment target.
Sponsors
Diakonhjemmet Hospital
The Dam Foundation
The Norwegian Rheumatism Association
Diakonhjemmet Hospital AS
REMEDY - Center for treatment of Rheumatic and Musculoskeletal Diseases
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients are eligible to be included in the study only if all the following criteria apply: * Adults ≥18 years of age at screening * Patients with a clinical diagnosis of gout * Serum urate level \>360 µmol/L at inclusion * Indication for urate lowering therapy assessed by medical doctor * Having a smartphone/tablet Patients are excluded from the study if any of the following criteria apply: * Pregnant or breastfeeding * Contraindication for urate lowering therapy * Does not understand Norwegian language * Major co-morbidities (e.g., malignancies, severe chronic kidney disease, severe mental disorders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptable overall feasibility of the app based on a total evaluation of the secondary endpoints for technical and operational feasibility. | 3 months | Feasibility criteria: * No serious and irreversible errors in app * Mean System Usability Scale score ≥68 * 70% with score ≥5 on a numeric rating scale (0-10) on patient satisfaction with the app * No serious and irreversible barriers to app-supported follow up experienced by patients or GPs * No other serious and irreversible problems with the app |
| Acceptable overall trial feasibility based on the total evaluation of the secondary endpoints for trial feasibility. | 3 months | Feasibility criteria: * Recruitment rate ≥50% of eligible patients * Withdrawal rate ≤20% of included patients * ≥90% of the patients register their sUA level in the app throughout the study * ≥90% of the patients answer baseline and 3 months questionnaires * No serious and irreversible risks or challenges that could hinder a successful clinical evaluation of the app in a large randomised controlled trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical feasibility: Patient-reported errors in app | 3 months | Number and type of technical errors in app reported by patients through the app and in questionnares at 3 months. |
| Technical feasibility: Patient-reported software performance and functionality | 3 months | Patient experiences of app performance, functionality and ease of use. From semi-structured interviews. |
| Technical feasibility: Patient-reported software usability | 3 months | Patient reported software usability, measured with The System Usability Scale (SUS), sum score 0-40 converted into 0-100, 100 = best score. From questionnaire at 3 months. |
| Technical feasibility: Patient-reported satisfaction with the app | 3 months | Patient satisfaction with the app, measured with one item rated on a 0-10 numeric rating scale, ranging from 'very dissatisfied' (0) to 'very satisfied' (10), from questionnaire at 3 months. |
| Technical feasibility: Patient-repoted benefits and disadvantages of the app | 3 months | Patients perceived benefits and disadvantages with the app collected from semi-structured interviews. |
| Operational feasibility: Patients' training requirements | 3 months | Patient evaluation of the demo films and instruction manual. From semi-structured interviews. |
| Operational feasibility: GP and patient-reported barriers and facilitators of app-supported gout follow-up | 3 months | Barriers and facilitators of app-supported gout follow-up experienced by patients and GPs. From semi-structured interviews and questionnaires at 3 months. |
| Operational feasibility: Patient satisfaction with the follow-up care | 3 months | Participant satisfaction with the care, measured by one item from The Nordic Patient Experiences Questionnaire, with five point response options ranging from "Very satisfied" to "Very dissatisfied" from questionnaire at 3 months. |
| Trial feasibility: Number of eligible patients per month and recruitment rate | 3 months | Number of patients screened, number of eligible patients, and the number of consenting patients every month, including information about how the patient was recruited. From identification and recruitment logs completed during the recruitment period and questionnaires at 3 months. |
| Trial feasibility: Patient dropout | 3 months | Number of patients that withdraw from the study, reasons for dropout (if provided). From logs completed during the study period. |
| Trial feasibility: Patients' app use | 3 months | Number of videos watched, registration of serum urate levels, medication adherence and flares in the app. From back-end data from the app and semi-structured interviews with patients. |
| Trial feasibility: Barriers and facilitators to study participation for patients and GPs | 3 months | Barriers and facilitators for study participation experienced by patients and GPs, from semi-structured interviews. |
| Trial feasibility: Provision of blood-test results from GPs | 3 months | Number of GPs providing blood test results and number of missing blood-test results from GPs, from questionnaires at 3 months. |
| Trial Feasibility: Serum urate level registrations in the app | 3 months | Number of correct, incorrect and missing serum urate level registrations in the app. Urate level registrations from app and urate levels from blood tests provided by GPs at 3 months. |
| Trial feasibility: Patients' response to questionnaires | 3 months | Response-rate to baseline questionnaire. Response-rate to 3-month questionnaire. |
| Trial feasibility: Adverse events | 3 months | The number of adverse events (AE), serious adverse events (SAE), adverse device effects (ADE) and serious adverse device effects (SADE). From questionnaires at 3-months to patients and GPs. |
Countries
Norway
Contacts
CONTACTFiona Aanesen, PhD
CONTACTSilje Søhus
PRINCIPAL_INVESTIGATORFiona Aanesen
Diakonhjemmet Hospital
Outcome results
None listed