The Return of Cardiovascular Information Trial (RECITE)

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07613853
Status
Recruiting

Conditions

  • Cardiovascular Health Risk Communication
  • Health Curiosity

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Coarse health result information presentation — BEHAVIORAL
    Participants are randomized to 1 of 2 cover-letter formats accompanying standard Dallas Heart Study (DHS) results. Both include AHA PREVENT Risk Score results from the DHS visit, comparison with the DHS Visit 3 distribution, and estimated 10-year CVD risk. Arm 1 (Coarse): color-coded risk categories/histogram for heart attack, stroke, and diabetes. Arm 2 (Fine/Granular): exact percentile/numerical risk with a red-to-green scale. Letters are sent at 8 and 12 weeks post-visit. All letters also recommend identical publicly available educational videos on physical activity, diet, and diabetes, hypertension, and cholesterol medications; link order is randomized. Unique de-identified QR codes/URLs track clicks only. At 16 weeks, participants receive follow-up calls about receipt, understanding, behavior change, healthcare visits/new diagnoses, and medication changes. Only de-identified DHS IDs are used; no PHI is collected.
  • Granular health risk information presentation — BEHAVIORAL
    Participants are randomized to 1 of 2 cover-letter formats accompanying standard Dallas Heart Study (DHS) results. Both include AHA PREVENT Risk Score results from the DHS visit, comparison with the DHS Visit 3 distribution, and estimated 10-year CVD risk. Arm 1 (Coarse): color-coded risk categories/histogram for heart attack, stroke, and diabetes. Arm 2 (Fine/Granular): exact percentile/numerical risk with a red-to-green scale. Letters are sent at 8 and 12 weeks post-visit. All letters also recommend identical publicly available educational videos on physical activity, diet, and diabetes, hypertension, and cholesterol medications; link order is randomized. Unique de-identified QR codes/URLs track clicks only. At 16 weeks, participants receive follow-up calls about receipt, understanding, behavior change, healthcare visits/new diagnoses, and medication changes. Only de-identified DHS IDs are used; no PHI is collected.

Study Details

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 (Quick Response) 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.

Key Dates

Start date
Apr 22, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1, Coarse Health Risk Format
    Arm 1, Coarse Risk Format: Participants receive the standard Dallas Heart Study results report with a cover letter demonstrating their AHA-PREVENT 10-year CVD risk score 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.
  • Experimental: Arm 2, Granular Health Risk Format
    Arm 2, Fine Risk Format: Participants receive the standard Dallas Heart Study results report with a cover letter demonstrating their AHA-PREVENT 10-year CVD risk score 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".

Primary Outcome Measure

QR Code use for Educational Health Videos [ Time Frame: 3 weeks after first health results letter is sent ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Deepa Raj

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