Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in change in LDL cholesterol levels from baseline to 6 months
研究概览
简要总结
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
详细描述
This is a single center randomized, two arm trial. The two study arms include usual care (standard notification) and implementation bundle intervention. UT Southwestern Medical Center will be the main study site and Carter Blood Care will serve as the recruitment site.
Screening/Baseline visit: Donors agreeing to participate in the study will be informed of study procedures and will provide informed consent. A 20 mL blood sample as well as a urine sample will be obtained for eligibility screening laboratories and baseline LDL-C.
Follow-up phone call: At 3 months post-randomization, participants in both arms will be briefly contacted by phone by the Research Assistant to thank them for their participation and to answer any study related questions.
End of study 6 month visit. Participants will engage in a virtual visit for end of study procedures. At this follow-up visit, the Research Assistant will assess for any adverse events and direct the participant to collect a fasting blood sample for repeat LDL-C measurement. The Research Assistant will administer an electronic survey and knowledge questionnaires. Additional clinical visits as desired by the participants' physicians will be allowed at their discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria
- •Age 18 to 75 years
排除标准
- •Currently taking medication to lower cholesterol
- •Taking any medication that can interact with statins
- •Pregnancy
- •Identified secondary cause of elevated lipids
- •Chronic liver disease or significantly elevated liver function tests (> 3 times upper limit)
研究组 & 干预措施
Control group (Usual care)
This arm will receive standard notification that is usually provided by Carter describing need to review with donor's primary care physician the presence of high cholesterol
干预措施: Usual care notification (Other)
Intervention Group (Implementation strategy bundle)
Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)
干预措施: Implementation Strategy Bundle (Behavioral)
Intervention Group (Implementation strategy bundle)
Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)
干预措施: Usual care notification (Other)
结局指标
主要结局
Difference in change in LDL cholesterol levels from baseline to 6 months
时间窗: Baseline, 6 months
This is the difference between the two study arms in change in LDL cholesterol level measurements obtained from lab work of blood samples from baseline and at 6 months
次要结局
- Difference in 6 month LDL-C values between the two treatment arms(6 months)
- Difference in participants' knowledge regarding FH at the end of study(6 months)
- Proportion of participants prescribed high-intensity statin therapy(6 months)
- Proportion of participants prescribed any statin therapy(6 months)
研究者
Amit Khera
PROFESSOR - Internal Medicine
University of Texas Southwestern Medical Center