Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
Purpose
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.
Conditions
- Familial Hypercholesterolemia
- Cholesterol, Elevated
- Genetic Disease
Eligibility
- Eligible Ages
- Between 2 Years and 75 Years
- Eligible Genders
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- 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.
- Primary Purpose
- Screening
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
No Intervention Usual Care |
Usual care arm will receive baseline and follow up surveys only. |
|
Recruiting Locations
Duluth, Minnesota 55805
Duluth, Minnesota 55805
More Details
- NCT ID
- NCT05238519
- Status
- Recruiting
- Sponsor
- Essentia Health
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).