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

Sponsor

Essentia Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05238519

Collaborator

St. Luke's Hospital of Duluth (Other), WHITESIDE Institute for Clinical Research (Other)

200

Enrollment

Locations

Arms

35.5

Anticipated Duration (Months)

100

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Familial Hypercholesterolemia Cholesterol, Elevated Genetic Disease	Behavioral: Motivational interview (MI)	Phase 3

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 (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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 6 month follow up survey will be sent to all participants.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 6 month follow up survey will be sent to all participants.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Usual Care Usual care arm will receive baseline and follow up surveys only.

Arm

Intervention/Treatment

Experimental: 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.

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.

No Intervention: Usual Care

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

Outcome Measures

Primary Outcome Measures

Knowledge of familial hypercholesterolemia [12 months post intervention]
Self-report of knowledge of personal history of FH will be assessed at baseline and follow up
Cascade screening of 1st degree family members [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 Outcome Measures

Proportion of participants with LDL<100 [12 months post enrollment]
Percent change in proportion of participants with LDL<100 from pre-enrollment LDL-c to follow up.
Proportion of participants with LDL<70 [12 months post enrollment]
Percent change in proportion of participants with LDL<70 from pre-enrollment LDL-c to follow up.
Absolute change in LDL from baseline to follow up [12 months post enrollment]
Compared absolute and percent lowering of LDL from pre-enrollment LDL-c to follow up.
Proportion of patients with self-report of genetic testing [12 months post enrollment]
Self-report of completion of a genetic test for familial hypercholesterolemia within 12 months of enrollment

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.