Genetic Testing and Motivational Counseling for FH (GENMOTIV-FH)

National Medical Research Center for Therapy and Preventive Medicine

Status: Active, not recruiting

Conditions: Hypercholesterolemia, Autosomal Dominant, 3; Apolipoprotein B-100, Familial Defective; Familial Hypercholesterolemia With Hyperlipemia; Treatment Adherence; Medication Adherence; Adherence, Medication; Hypercholesterolemia, Familial, 2; Familial Hypercholesterolemia - Heterozygous; Hypercholesterolemia, Familial; Hypercholesterolemia, Familial, 4; Therapeutic Adherence and Compliance; Hypercholesterolemia, Familial, 1; Patient Compliance; Motivational Interviewing; Treatment Adherence and Compliance; Hypercholesterolemia, Autosomal Dominant, Type B; Therapeutic Adherence; Genetic Testing; Hypercholesterolemia, Autosomal Dominant; Adherence; Compliance; Hypercholesterolemia, Familial, 3; Patient Adherence; Adherence, Patient; Hypercholesterolemia, Familial, 4, Autosomal Recessive; Familial Hypercholesterolemia

Treatments: Behavioral: Motivational Counseling; Other: Visit 2; Other: Visit 1; Genetic: Genetic Testing; Other: Visit 4; Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet); Diagnostic Test: Lipid analysis; Other: Visit 3

Study type: Interventional

Funder types: Other

Identifiers

NCT04656028

08-03/19

Details and patient eligibility

About

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.

Full description

There are several tasks of the study:

1. 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.
2. To assess the impact of knowledge of patients with FH about the result of their FH genetic testing on the effectiveness of cascade screening.
3. To assess the influence of motivational counseling of patients with FH on the adherence to a healthy lifestyle and hypolipidemic therapy.
4. To assess the impact of motivational counseling of patients with FH on the effectiveness of cascade screening.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Probable or definite diagnosis of FH according to the Dutch criteria (6 points or more);
• Signed informed consent;

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 4 patient groups

Group 1 - without genetic testing; subgroup without motivational counseling

Active Comparator group

Description:

Group 1 - without genetic testing; subgroup without motivational counseling

Treatment:

Other: Visit 3

Diagnostic Test: Lipid analysis

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)

Other: Visit 4

Other: Visit 2

Other: Visit 1

Group 1 - without genetic testing; subgroup with motivational counseling

Experimental group

Description:

Group 1 - without genetic testing; subgroup with motivational counseling

Treatment:

Other: Visit 3

Diagnostic Test: Lipid analysis

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)

Other: Visit 4

Other: Visit 2

Other: Visit 1

Behavioral: Motivational Counseling

Group 2 - with genetic testing; subgroup without motivational counseling

Experimental group

Description:

Group 2 - genetic testing has been performed; subgroup without motivational counseling.

Treatment:

Other: Visit 3

Diagnostic Test: Lipid analysis

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)

Other: Visit 4

Other: Visit 2

Other: Visit 1

Genetic: Genetic Testing

Group 2 - with genetic testing; subgroup with motivational counseling

Experimental group

Description:

Group 2 - genetic testing has been performed; subgroup with motivational counseling.

Treatment:

Other: Visit 3

Diagnostic Test: Lipid analysis

Other: Consultation with a cardiologist-lipidologist (correction of therapy, lifestyle, diet)

Other: Visit 4

Other: Visit 2

Other: Visit 1

Genetic: Genetic Testing

Behavioral: Motivational Counseling