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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Familial Hypercholesterolemia, Cholesterol, Elevated, Genetic Disease

Intervention / Treatment
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* Behavioral: Motivational interview (MI)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interview<br>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)<br>* 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.<br>|
| No Intervention: Usual Care<br>Usual care arm will receive baseline and follow up surveys only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholesterol, motivational interview, survey, cascade screening