Improved Diagnosis of Familial Hypercholesterolemia Across the Northland (ID-FH)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 2
- 主要终点
- Knowledge of familial hypercholesterolemia
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual Care
Usual care arm will receive baseline and follow up surveys only.
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.
干预措施: Motivational interview (MI) (Behavioral)
结局指标
主要结局
Knowledge of familial hypercholesterolemia
时间窗: 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
时间窗: 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
次要结局
- Proportion of participants with LDL<100(12 months post enrollment)
- Proportion of patients with self-report of genetic testing(12 months post enrollment)
- Proportion of participants with LDL<70(12 months post enrollment)
- Absolute change in LDL from baseline to follow up(12 months post enrollment)