Improving awareness and management of Familial Hypercholesterolemia
Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
This study is testing if a motivational interview can help people with suspected Familial Hypercholesterolemia better understand and manage their condition compared to usual care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 2 Years to 75 Years |
| Sex | All |
| Sponsor | Essentia Health Academic / other |
| Locations | 2 sites (Duluth, Minnesota and 1 other locations) |
| Trial ID | NCT05238519 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the diagnosis and management of Familial Hypercholesterolemia (FH) by enrolling patients with suspected FH and randomizing them to receive either usual care or a motivational interview. The intervention includes personalized risk communication and behavior change techniques delivered remotely. Participants will complete a baseline survey and receive follow-up assessments to evaluate their knowledge of FH and the uptake of cascade screening among their relatives. The study is conducted at two sites in Minnesota and Wisconsin.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2-75 years with a clinical diagnosis or suspected FH and elevated cholesterol levels.
Not a fit: Patients with other medical conditions contributing to hyperlipidemia or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better awareness and management of Familial Hypercholesterolemia, ultimately improving patient outcomes.
How similar studies have performed: Other studies have shown success in using motivational interviewing and risk communication to improve health outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Duluth, Minnesota and 1 other locations
- Aspirus St. Luke's Hospital — Duluth, Minnesota, United States (Recruiting)
- Essentia Health — Duluth, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Catherine Benziger, MD MPH
- Email: cholesterolstudy@essentiahealth.org
- Phone: 218-576-0506
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.