Health Literacy-Based, Nurse-Led Telehealth Support for Gout Self-Management: the Danish Randomized GOUTCONNECT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Proportion of participants achieving target serum urate (s-urate) concentration
研究概览
简要总结
The aim of this clinical trial is to evaluate whether nurse-led telehealth support helps individuals with gout better manage their condition and adhere to urate-lowering medication after discharge from a rheumatology clinic.
Eligible patients will be recruited from five rheumatology departments in the Central Denmark Region after achieving two consecutive target serum urate levels-below 0.36 mmol/L, or below 0.30 mmol/L for patients with tophi.
Participants will be adults with gout who meet specific medical criteria, are taking medications such as allopurinol or Adenuric, and are able to read and write Danish.
Participants will be randomly assigned to one of two groups:
- Intervention group: nurse-led telehealth support.
- Control group: usual care with follow-up by their general practitioner.
The primary goal is to support patients in maintaining healthy uric acid levels after 52 weeks.
Participants in the nurse-led group have the option to choose from four support options:
I1: App-Based Support - an app provides information and reminders. I2: Letter Reminders - messages are sent via digital or postal mail. I3: Text Reminders - SMS messages are sent every three months. I4: Phone Support - nurses call three times a year to check in.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •≥18 years old
- •Fulfills ACR/EULAR 2015 Gout Classification Criteria
- •Estimated Glomerular Filtration Rate (e-GFR) >30 ml/min
- •Prescribed Allopurinol or Adenuric, and achieved two consecutive serum urate levels of two consecutive serum urate levels of ≤0.30 mmol/l for patients with tophi and ≤0.36 mmol/L for patients without tophi
- •Have sufficient Danish reading and writing skills to understand information and complete questionnaires.
排除标准
- •Cognitively impaired, unable to understand or provide informed consent.
研究组 & 干预措施
Nurse-led self-management support
干预措施: Nurse-Led Self-Management Support (Other)
GP-follow up
干预措施: GP-follow up (Other)
结局指标
主要结局
Proportion of participants achieving target serum urate (s-urate) concentration
时间窗: 52 weeks
The number and proportion of participants with a serum urate concentration equal to or less than 0.36 mmol/L or 0.30 mmol/L if tophi, at 52 weeks after randomization.
Gout impact
时间窗: 52 weeks
Changes in Gout Impact Scale (GIS). GIS is a patient-reported outcome measure assessing the impact of gout on health-related quality of life. The GIS includes domains such as gout concern overall, gout medication side effects, unmet treatment need, well-being during gout attack, and concern during gout attack. Each domain is scored on a 0-100 scale, with higher scores indicating greater impact (worse health status). Change from baseline to week 52 will be calculated, with negative change scores indicating improvement (i.e., reduced gout impact).
次要结局
- Quality of life one year after discharge from a rheumatology clinic indicated by EQ-5D-5L.(52 weeks)
- Proportion of participants adherent to urate lowering drugs based on CQR-5(52 weeks)