Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
NCT05238519 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2026-01-16
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.
Conditions
- Familial Hypercholesterolemia
- Cholesterol, Elevated
- Genetic Disease
Interventions
- BEHAVIORAL
-
Motivational interview (MI)
The MI intervention is adapted from the CHEERS study intervention (M Health Fairview) found to be effective in promoting lipid screening in patients at increased risk for FH. Within one month of completion of the baseline survey, a study coordinator, who received training in motivational interview integrity, will conduct a 20-40-minute (depending on participant needs) telephone or virtual (zoom) interview with participants randomized to this arm. Participants will be assessed on their readiness to get their cholesterol checked and discuss with family members the risk of FH.
Sponsors & Collaborators
-
WHITESIDE Institute for Clinical Research
collaborator UNKNOWN -
Aspirus St. Luke's Hospital
collaborator UNKNOWN -
Essentia Health
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 2 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-02-15
- Primary Completion
- 2024-11-06
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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