The Return of Cardiovascular Information Trial (RECITE)

NCT07613853 | Recruiting DMC

• 2 other identifiers: STU202604751R01DK145081-01
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Health Curiosity; Cardiovascular Health Risk Communication

Keywords

Health information communication; Behavioral intervention trial

Outcome Measures

Primary Outcomes (2)

• QR Code use for Educational Health Videos

  Number of clicks per link/QR code in the 3 weeks after Result Letter #1 sent

  3 weeks after first health results letter is sent

• Change in Educational Health Video Engagement

  Change in number of clicks per link/QR code in the 3 weeks after Result Letter #2

  3 weeks following the second result letter is sent

Secondary Outcomes (1)

• Self-reported health behavior changes

  16 weeks after randomization

Other Outcomes (1)

• Incidence of adverse events

  on an annual basis from the time participants enroll in the Dallas Heart Study cohort until patient expires

Study Arms (2)

Arm 1, Coarse Health Risk Format

EXPERIMENTAL

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.

Behavioral: Coarse health result information presentation

Arm 2, Granular Health Risk Format

EXPERIMENTAL

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".

Behavioral: Granular health risk information presentation

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.

Arm 1, Coarse Health Risk Format

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.

Arm 2, Granular Health Risk Format

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Attendance of the Dallas Heart Study-4 clinical visit
• Participant confirms ability and willingness to utilize short links/QR codes during clinical visit

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

• Amil M Shah, MD, MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepa Raj, BA, MPH

CONTACT

214-648-9256; deepa.raj@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor- Internal Medicine

Model Details: 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 10-10-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: Coarse Risk Format (as color-coded categories (green = low risk, red = high risk) and representation of score in a histogram) or Granular risk format (precise numerical exact numerical percentile).

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)