The Self-management App 'MinUrinsyregikt' for Patients With Gout. The ReMonit Gout Feasibility Study in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Acceptable overall feasibility of the app based on a total evaluation of the secondary endpoints for technical and operational feasibility.
研究概览
简要总结
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:
- To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- 未提供
结局指标
主要结局
Acceptable overall feasibility of the app based on a total evaluation of the secondary endpoints for technical and operational feasibility.
时间窗: 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.
时间窗: 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
次要结局
- Technical feasibility: Patient-reported errors in app(3 months)
- Technical feasibility: Patient-reported software performance and functionality(3 months)
- Technical feasibility: Patient-reported software usability(3 months)
- Technical feasibility: Patient-reported satisfaction with the app(3 months)
- Technical feasibility: Patient-repoted benefits and disadvantages of the app(3 months)
- Operational feasibility: Patients' training requirements(3 months)
- Operational feasibility: GP and patient-reported barriers and facilitators of app-supported gout follow-up(3 months)
- Operational feasibility: Patient satisfaction with the follow-up care(3 months)
- Trial feasibility: Number of eligible patients per month and recruitment rate(3 months)
- Trial feasibility: Patient dropout(3 months)
- Trial feasibility: Patients' app use(3 months)
- Trial feasibility: Barriers and facilitators to study participation for patients and GPs(3 months)
- Trial feasibility: Provision of blood-test results from GPs(3 months)
- Trial Feasibility: Serum urate level registrations in the app(3 months)
- Trial feasibility: Patients' response to questionnaires(3 months)
- Trial feasibility: Adverse events(3 months)
研究者
Fiona Aanesen
Postdoctoral fellow
Diakonhjemmet Hospital