Familial Hypercholesterolemia Clinical Trial
— ID-FHOfficial title:
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
The overall goal of this study is to promote awareness of Familial Hypercholesterolemia (FH). The investigators aim to enroll patients with suspected FH into the study and will randomize them to receive usual care or motivational interview. Primary study outcomes include knowledge of FH, as well as clinical and patient-reported outcomes. This study aims to promote optimal disease management and improve outcomes of FH patients.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age 2-75 years - patients with existing clinical diagnosis or suspected FH - known genetic mutation of FH - patients with an initial (pretreatment) LDL level >190 mg/dL or total cholesterol >300 mg/dL (age >19 years) or LDL-c > 160mg/dL or total cholesterol >260 mg/dL in children age 2-19 years - patients currently taking a lipid-lowering medication and have an LDL >124 mg/dL or total cholesterol >195 mg/dL - capable of providing informed consent - Patients should reside in Minnesota, Wisconsin or North Dakota. Exclusion Criteria: - Lack of research authorization - unable to provide informed consent (including non-English speaking individuals) - known medical condition other than FH that is thought to contribute to hyperlipidemia (i.e., untreated hypothyroidism, nephrotic syndrome, cholestasis hypopituitarism) - Pregnant women and prisoners will also be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Essentia Health | Duluth | Minnesota |
United States | St. Luke's Hospital | Duluth | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Essentia Health | St. Luke's Hospital of Duluth, WHITESIDE Institute for Clinical Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knowledge of familial hypercholesterolemia | Self-report of knowledge of personal history of FH will be assessed at baseline and follow up | 12 months post intervention | |
Primary | Cascade screening of 1st degree family members | Cascade screening will be assessed using self-report of either a) discussion about lipid screening with at least one first-degree relative or b) discussion about genetic testing for FH (in the patient's first-degree relatives) within 6 months of the intervention | 6 months post intervention | |
Secondary | Proportion of participants with LDL<100 | Percent change in proportion of participants with LDL<100 from pre-enrollment LDL-c to follow up. | 12 months post enrollment | |
Secondary | Proportion of participants with LDL<70 | Percent change in proportion of participants with LDL<70 from pre-enrollment LDL-c to follow up. | 12 months post enrollment | |
Secondary | Absolute change in LDL from baseline to follow up | Compared absolute and percent lowering of LDL from pre-enrollment LDL-c to follow up. | 12 months post enrollment | |
Secondary | Proportion of patients with self-report of genetic testing | Self-report of completion of a genetic test for familial hypercholesterolemia within 12 months of enrollment | 12 months post enrollment |
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