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

NCT05238519 | Active Not Recruiting Phase 3

• 1 other identifier: EH21700
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Familial Hypercholesterolemia; Cholesterol, Elevated; Genetic Disease

Keywords

cholesterol; motivational interview; survey; cascade screening

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Proportion of participants with LDL<100

  12 months post enrollment

• Proportion of participants with LDL<70

  12 months post enrollment

• Absolute change in LDL from baseline to follow up

  12 months post enrollment

• Proportion of patients with self-report of genetic testing

  12 months post enrollment

Study Arms (2)

Motivational Interview

EXPERIMENTAL

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)

Usual Care

NO INTERVENTION

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

Interventions

Motivational interview (MI) 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.

Motivational Interview

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Essentia Health: lead
• WHITESIDE Institute for Clinical Research: collaborator
• Aspirus St. Luke's Hospital: collaborator

Study Sites (2)

Aspirus St. Luke's Hospital

Duluth, Minnesota, 55805, United States

Location

Essentia Health

Duluth, Minnesota, 55805, United States

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II; Hypercholesterolemia; Genetic Diseases, Inborn

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A baseline survey will be sent to eligible participants age 2-75 years. Participants age 18-75 years who complete the survey will be randomly assigned to receive a motivational interview intervention or usual care. If an eligible patient is under the age of 18 years, they will not be eligible to receive a motivational interview. Therefore, the patient's parent or legal guardian will be the primary target for participation in the survey and will be asked to complete the survey from their own perspective. The patient's parent will be recognized as the "participant" in this study and will then be eligible for randomization to the MI arm. A follow up survey will be sent to all participants approximately 6 months after completion of the baseline survey.

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: February 15, 2022
• Primary Completion: November 6, 2024
• Study Completion: June 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (2)