The Return of Cardiovascular Information Trial (RECITE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,500
研究概览
简要总结
The goal of this behavioral interventional trial is to determine how best to communicate personalized cardiovascular risk information and support behavior change among participants enrolled in the Dallas Heart Study (DHS) cohort. The main questions it aims to answer are:
- What are the effects of presenting health information in a coarse vs. granular manner? (This question will be measured by randomizing participants to two groups: one group will get a cover letter with their health information communicated in a more detailed manner, while another group will receive a cover letter which presents their health information in a coarse manner. Two letters will be sent containing the same information regarding their results. 4 months after the second letter, participants will be asked about changes made for their health after receiving the letter)
- How curious are people about bettering their health after being presented their health information? (This question will be measured by placing QR codes linking educational health videos on each cover letter. Each letter will be sent twice with exactly the same health information but with new QR codes. QR code use will be tracked by the study staff)
Researchers will assess whether participants who received different style letters had different responses to their health behaviors and medication afterward and will measure this with a follow-up phone call. Researchers will also assess the use of QR codes showing health-related videos (about physical activity, heart-healthy diet, diabetes medication, statin medication) by sending out two different letters with the same health information and format, but with different QR code-linked videos.
Participants will:
- Receive two letters in the mail, 4 weeks apart, containing their results from the Dallas Heart Study's 4th visit. The cover letter for this report will be randomized and will contain coarse vs. granular presentations of the participant's heart health risk.
- Receive a follow up call after 4 months to assess: whether they received the letter, whether they understood the information provided, whether they made any health changes after receiving the letter, whether they saw a healthcare provider after receiving the letter, whether the letter prompted a new diagnosis by a doctor, and whether the participant made any medication changes after the letter.
详细描述
The Return of Cardiovascular Information Trial (RECITE) is a multi-factorial, adaptive randomized behavioral intervention trial which aims to determine how best to communicate personalized cardiovascular risk information and support behavior change among participants attending the Dallas Heart Study (DHS) fourth visit (DHS-4). This embedded behavioral intervention trial will evaluate two independent intervention components-risk information presentation and personalized action-planning support-to identify communication strategies that most effectively motivate and sustain healthy behavior change. The randomized intervention will be receipt of one of two different cover letter templates for the participant post-visit return-of-results letter.
Intervention Components:
The two primary treatment arms differ only in how one's health data measured during the DHS clinic visit are presented in the cover letter. Each cover letter shows the participant's AHA PREVENT Risk Score results based on assessments performed at the DHS Visit. The risk score representation provides each participant's score compared to the distribution among DHS participants at Visit 3 (2020-2024). Each letter also provides the participant's actual estimated 10-year CVD risk based on the PREVENT Risk Score. To evaluate whether simplified (coarse) or detailed (fine) presentation of risk information better motivates behavior change, participants will be randomized to template cover letters presenting summary risk information as either:
- Arm 1, Coarse Risk Format: Participants receive the standard DHS-4 result report supplemented with visually intuitive risk indicators-such as color-coded categories (green = low risk, red = high risk) and representation of score in a histogram-for outcomes including heart attack, stroke, and diabetes.
- Arm 2, Fine Risk Format: Participants receive the same standard results report, but with precise numerical exact numerical percentile. (e.g., "Your risk of an adverse heart event is higher than 72 percent of DHS participants.") Instead of categorical color cues, there will be a line underlining the risk number that ranges from red "100" to green "0".
Each participant's result letter will be sent to them twice, initially approximately 8 weeks after their DHS Visit 4, and a second time 12 weeks after their visit. All participants will otherwise receive the same clinical test results and observational summaries, preceded by a cover letter, to ensure consistency with standard DHS return-of-results practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attendance of the Dallas Heart Study-4 clinical visit
- •Participant confirms ability and willingness to utilize short links/QR codes during clinical visit
排除标准
- •Did not attend the Dallas Heart Study-4 clinical visit
- •Did not confirm ability and willingness to utilize short links/QR codes
- •Participants for whom a PREVENT-CVD score cannot be calculated (those who did not complete a laboratory collection, and/or height/weight measurements [for BMI calculation]), and/or BP assessment, and/or did not complete the medical history questionnaire)
研究者
Amil Shah
Professor- Internal Medicine
University of Texas Southwestern Medical Center
