Impact of Genetic Testing and Motivational Counseling on the Adherence to Healthy Lifestyle and Hypolipidemic Therapy and Efficiency of Cascade Screening in Patients With Familial Hypercholesterolemia (GENMOTIV-FH)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in the number of relatives who underwent cascade screening
研究概览
简要总结
To date, there are highly effective lipid-lowering drugs, the combination of which makes it possible to achieve the target level of LDL-C in most patients with familial hypercholesterolemia (FH). However, the effectiveness of treatment of FH patients strongly depends on adherence to lipid-lowering therapy and to the healthy lifestyle, as well as the detection of the disease and the therapy prescription as early as possible, better in childhood. The aim of the study is to assess the impact of genetic testing and motivational counseling on the effectiveness of treatment and cascade screening in patients with FH.
详细描述
There are several tasks of the study:
- To assess the effect of knowledge of patients with FH about the result of their FH genetic testing on the adherence to a healthy lifestyle and hypolipidemic therapy.
- To assess the impact of knowledge of patients with FH about the result of their FH genetic testing on the effectiveness of cascade screening.
- To assess the influence of motivational counseling of patients with FH on the adherence to a healthy lifestyle and hypolipidemic therapy.
- To assess the impact of motivational counseling of patients with FH on the effectiveness of cascade screening.
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
- Single (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
- •Probable or definite diagnosis of FH according to the Dutch criteria (6 points or more);
- •Signed informed consent;
排除标准
- •Pregnancy or lactation at the time of enrollment
- •Established active severe infectious disease or severe hematologic, metabolic, gastrointestinal or endocrine dysfunctions (for example, uncontrolled thyroid dysfunction or uncontrolled diabetes mellitus) in the opinion of the investigator
- •Active liver disease
- •Estimated GFR≤ 30 ml / min / 1.73m2
- •Any other conditions at Visit 1 that, according to the investigator's opinion, render the patient ineligible for inclusion in the study, may interfere with the patient's participation in the study or patient's completion of the study.
结局指标
主要结局
Change in the number of relatives who underwent cascade screening
时间窗: 3 months
Change in the number of relatives who underwent cascade screening (% of relatives out of all available relatives. Available relatives are those who are alive and live in the region of where the study is conducted (Moscow and Moscow region)
Change in the proportion of people adhering to the recommended physical activity
时间窗: 3 months
Change in the proportion of people adhering to the recommended physical activity (according to the Global Physical Activity Questionnaire (GPAQ))
Change in the proportion of people adhering to drug therapy
时间窗: 3 months
Change in the proportion of people adhering to drug therapy according to the questionnaire MARS-5
Change in the proportion of individuals adhering to the recommended dietary recommendations
时间窗: 3 months
Change in the proportion of individuals adhering to the recommended dietary recommendations (according to 24-hour Dietary Recall and Food Frequency Questionnaires)
Change in the proportion of people who have reached the target level of LDL-Cholesterol
时间窗: 3 months
Change in the proportion of people who have reached the target level of LDL-Cholesterol (target values of LDL-C according to the ESC Dislipidaemia Guidelines 2019)
次要结局
- Change in the proportion of individuals adhering to the recommended dietary recommendations(15 months)
- Change in the number of relatives who underwent cascade screening(15 months)
- Change in the proportion of people adhering to drug therapy(15 months)
- Change in the proportion of people who have reached the target level of LDL-Cholesterol(15 months)
- Change in the proportion of people adhering to the recommended physical activity(15 months)