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

Study Overview

• Status: Active, not recruiting
• Conditions: Familial Hypercholesterolemia; Genetic Disease; Cholesterol, Elevated
• Intervention / Treatment: Behavioral: Motivational interview (MI)

Detailed 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 (Site A) and Aspirus St. Luke's Hospital (Site B) 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 follow-up survey will be sent to participants approximately 6 months after completion of the baseline survey, 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).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Health
    • Duluth, Minnesota, United States, 55805
      • Aspirus St. Luke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interview; Motivational interview arm will receive a message to schedule a follow up motivational interview via telephone or video after the baseline survey as well as follow up surveys.	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.
No Intervention: Usual Care; Usual care arm will receive baseline and follow up surveys only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Essentia Health
• Collaborators: WHITESIDE Institute for Clinical Research; Aspirus St. Luke's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): November 6, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: survey; cholesterol; motivational interview; cascade screening
• Additional Relevant MeSH Terms: Metabolism, Inborn Errors; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Genetic Diseases, Inborn; Hypercholesterolemia; Hyperlipoproteinemia Type II; Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: EH21700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No