Genetic Testing and Motivational Counseling for FH
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Familial Hypercholesterolemia With Hyperlipemia
- Adherence
- Adherence, Medication
- Treatment Adherence and Compliance
- Motivational Interviewing
- Adherence, Patient
- Apolipoprotein B-100, Familial Defective
- Hypercholesterolemia, Familial, 4, Autosomal Recessive
- Compliance
- Hypercholesterolemia, Familial
- Familial Hypercholesterolemia
- Hypercholesterolemia, Familial, 4
- Medication Adherence
- Familial Hypercholesterolemia - Heterozygous
- Hypercholesterolemia, Familial, 2
- Hypercholesterolemia, Familial, 3
- Genetic Testing
- Therapeutic Adherence and Compliance
- Treatment Adherence
- Hypercholesterolemia, Autosomal Dominant
- Hypercholesterolemia, Autosomal Dominant, Type B
- Patient Compliance
- Therapeutic Adherence
- Hypercholesterolemia, Autosomal Dominant, 3
- Hypercholesterolemia, Familial, 1
- Patient Adherence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The trial is a randomized prospective cohort study. The study will include patients 18 years of age and older with a probable or definite diagnosis of FH according to the Dutch criteria (6 points or more). A total of 180 patients will be included in the study. All patients will be randomly divided into 2 groups for genetic testing. Randomization will be performed as block randomization with a 2:1 allocation ratio (2 with genetic testing : 1 without genetic testing). The allocation ratio 2:1 was chosen because in the group with genetic testing there will be cases where mutation(s) associated with FH will be identified and cases where the mutation(s) will not be identified. A separate analysis is planned in patients with genetic testing and identified mutation(s) and in patients with genetic testing but no identified mutation(s). Each study group will be randomized into 2 subgroups depending on the conduct of motivational counseling with an 1:1 allocation ratio.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 testi...
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.
Tracking Information
- NCT #
- NCT04656028
- Collaborators
- Moscow State University of Medicine and Dentistry
- Investigators
- Principal Investigator: Alexey Meshkov, MD, PhD National Medical Research Centre for Therapy and Preventive Medicine, Ministry of Health of Russia Study Director: Alexandra Ershova, MD, PhD National Medical Research Centre for Therapy and Preventive Medicine, Ministry of Health of Russia
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