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| Name | Class |
|---|---|
| WHITESIDE Institute for Clinical Research | UNKNOWN |
| Aspirus St. Luke's Hospital | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interview | Experimental | 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. |
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| Usual Care | No Intervention | Usual care arm will receive baseline and follow up surveys only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interview (MI) | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aspirus St. Luke's Hospital | Duluth | Minnesota | 55805 | United States | ||
| Essentia Health |
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| ID | Term |
|---|---|
| D006938 | Hyperlipoproteinemia Type II |
| D006937 | Hypercholesterolemia |
| D030342 | Genetic Diseases, Inborn |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006951 | Hyperlipoproteinemias |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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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.
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|
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 |
| Duluth |
| Minnesota |
| 55805 |
| United States |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |