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NCT Number: NCT05238519

Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Familial Hypercholesterolemia Cholesterol, Elevated Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Disease Genetic Diseases, Inborn Hypercholesterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

2 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aspirus St. Luke's Hospital, Duluth, Minnesota, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Knowledge of familial hypercholesterolemia

    Time frame: 12 months post intervention

    Self-report of knowledge of personal history of FH will be assessed at baseline and follow up

  2. Cascade screening of 1st degree family members

    Time frame: 6 months post intervention

    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

Secondary outcomes

  1. Proportion of participants with LDL<100

    Time frame: 12 months post enrollment

    Percent change in proportion of participants with LDL<100 from pre-enrollment LDL-c to follow up.

  2. Proportion of participants with LDL<70

    Time frame: 12 months post enrollment

    Percent change in proportion of participants with LDL<70 from pre-enrollment LDL-c to follow up.

  3. Absolute change in LDL from baseline to follow up

    Time frame: 12 months post enrollment

    Compared absolute and percent lowering of LDL from pre-enrollment LDL-c to follow up.

  4. Proportion of patients with self-report of genetic testing

    Time frame: 12 months post enrollment

    Self-report of completion of a genetic test for familial hypercholesterolemia within 12 months of enrollment

Sponsors and collaborators

Lead sponsor

Essentia Health

Other

Collaborators

  • Aspirus St. Luke's Hospital
  • WHITESIDE Institute for Clinical Research

Registry information

Acronym: ID-FH

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 14, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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