The Return of Cardiovascular Information Trial (RECITE)

Summary

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.

Conditions

• Health Curiosity
• Cardiovascular Health Risk Communication

Interventions

BEHAVIORAL

Coarse health result information presentation

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.

BEHAVIORAL

Granular health risk information presentation

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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Amil M Shah, MD, MPH · University of Texas Southwestern Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-30

Primary Completion

2028-04-30

Completion

2028-08-31