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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05238519
Other study ID # EH21700
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 15, 2022
Est. completion date February 2025

Study information

Verified date January 2024
Source Essentia Health
Contact Catherine Benziger, MD MPH
Phone 218-576-0506
Email cholesterolstudy@essentiahealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 (EH) and St. Luke's Hospital (SLH) 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 6-month follow-up survey will be sent to participants 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 75 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Essentia Health Duluth Minnesota
United States St. Luke's Hospital Duluth Minnesota

Sponsors (3)

Lead Sponsor Collaborator
Essentia Health St. Luke's Hospital of Duluth, WHITESIDE Institute for Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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