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

Essentia Health

Status and phase: Active, not recruiting; Phase 3

Conditions: Cholesterol, Elevated; Genetic Disease; Familial Hypercholesterolemia

Treatments: Behavioral: Motivational interview (MI)

Study type: Interventional

Funder types: Other

Identifiers

NCT05238519

EH21700

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 2 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Motivational Interview

Experimental group

Description:

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.

Treatment:

Behavioral: Motivational interview (MI)

Usual Care

No Intervention group

Description:

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