Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gaia AG
- 入组人数
- 278
- 试验地点
- 1
- 主要终点
- Fasting LDL-C levels
研究概览
简要总结
The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol.
The main questions it aims to answer are:
- Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone?
- Does lipodia help improve other health outcomes, like how confident participants feel in managing their health?
Researchers will compare two groups:
- Intervention group: Participants use the lipodia intervention and continue their usual treatment.
- Control group: Participants continue with their usual treatment only.
Participants will:
- Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months
- Have blood tests at each lab visit to check their cholesterol and other blood fat levels
- Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis
- •LDL-C levels above risk-adapted target
- •TG levels < 400 mg/dL
- •Stability of potential drug treatment during the last 4 weeks
- •Stability of potential hormonal treatment during the last 6 months
- •Patient was made aware of lifestyle measures by GP or specialist
- •Consent to participation
- •Sufficient knowledge of the German language
排除标准
- •Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes
- •Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes
- •Patients receiving plasmapheresis
- •Lp(a) > 50 mg/dL
- •current pregnancy or planned pregnancy during the study period
- •planned major operations
- •liver dysfunction
- •end-stage renal failure
- •other systemic conditions that might interfere with successful study participation
- •Plans to change drug (including hormonal) treatment in the upcoming 6 months
- •Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past
研究组 & 干预措施
Intervention group
Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU).
lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking.
The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days.
干预措施: lipodia (Behavioral)
Control group
Participants allocated to the control group will receive access to treatment as usual (TAU).
结局指标
主要结局
Fasting LDL-C levels
时间窗: 6 months
次要结局
- Patients' activation(6 months)
- Fasting non-HDL-C levels(6 months)
- Health-related quality of life(6 months)
- BMI(6 months)
- Fasting triglyceride levels(6 months)
- Fasting HDL-C levels(6 months)
- Fasting LDL-C levels(3 months)