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

NCT ID: NCT05238519

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2026-06-30

Brief 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.

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).

Conditions

Familial Hypercholesterolemia; Cholesterol, Elevated; Genetic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Motivational interview (MI)

Intervention Type: BEHAVIORAL

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.

Usual Care

Usual care arm will receive baseline and follow up surveys only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

WHITESIDE Institute for Clinical Research

UNKNOWN

Sponsor Role: collaborator

Aspirus St. Luke's Hospital

UNKNOWN

Sponsor Role: collaborator

Essentia Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aspirus St. Luke's Hospital

Duluth, Minnesota, United States

Essentia Health

Duluth, Minnesota, United States

Countries

United States

Other Identifiers

EH21700

Identifier Type: -

Identifier Source: org_study_id