Clinical trial NCT05238519: Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
Official title: Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Familial Hypercholesterolemia
Cholesterol, Elevated
Genetic Disease
Keywords: cholesterol
motivational interview
survey
cascade screening
Lead sponsor: Essentia Health
Sponsor class: OTHER
Collaborators: name: Aspirus St. Luke's Hospital
name: WHITESIDE Institute for Clinical Research
First posted: 2022-02-14
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 follow up survey will be sent to all participants approximately 6 months after completion of the baseline survey.
Primary purpose: SCREENING

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.

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 (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).

Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge of familial hypercholesterolemia
timeFrame: 12 months post intervention
measure: Cascade screening of 1st degree family members
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Proportion of participants with LDL<100
timeFrame: 12 months post enrollment
measure: Proportion of participants with LDL<70
timeFrame: 12 months post enrollment
measure: Absolute change in LDL from baseline to follow up
timeFrame: 12 months post enrollment
measure: Proportion of patients with self-report of genetic testing
timeFrame: 12 months post enrollment
Other outcomes:
Locations:
city: Duluth
country: United States
facility: Aspirus St. Luke's Hospital
state: Minnesota
city: Duluth
country: United States
facility: Essentia Health
state: Minnesota
Study officials:
References: