Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH) — ID-FH  

Familial Hypercholesterolemia Clinical Trial

Official title: Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is a randomized 2-arm study designed to examine the impact of a personalized remote intervention that includes evidence-based risk communication and behavior change techniques with navigation. Patients who meet the inclusion criteria from both Essentia Health (EH) and St. Luke's Hospital (SLH) will be invited to complete the baseline survey. Participants will be randomized to one of two study arms: usual care (UC) and motivational interview (MI). Participant assignment occurs after completion of the baseline survey. Participants randomized to receive a MI will be contacted via telephone or email to schedule a date and time when they are available to receive a video or phone call from the study coordinator. During the MI, participants will be assessed on their readiness to communicate risk with family members. A letter will be sent to the participants physician for notice of the participation in the study. A 6-month follow-up survey will be sent to participants in both arms of the study. The study arms will be compared with regard to awareness and treatment of FH (aim 1), as well as the uptake of cascade screening in first- and second-degree relatives (aim 2). ;

Related Conditions & MeSH terms

• Cholesterol, Elevated
• Familial Hypercholesterolemia
• Genetic Disease
• Genetic Diseases, Inborn
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

• NCT number: NCT05238519
• Study type: Interventional
• Source: Essentia Health
• Contact: Catherine Benziger, MD MPH
• Phone: 218-576-0506
• Email: cholesterolstudy@essentiahealth.org
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2022
• Completion date: February 2025