Recruiting

Risk Communication

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07613853

Conditions

Health Curiosity

Cardiovascular Health Risk Communication

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Interventions

Coarse health result information presentation

Granular health risk information presentation

Study Details

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

Study ID

NCT07613853

Start date

Apr 22, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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".

Interventions

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.

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.

Primary outcome measure

  • QR Code use for Educational Health Videos [ Time Frame: 3 weeks after first health results letter is sent ]
  • Change in Educational Health Video Engagement [ Time Frame: 3 weeks following the second result letter is sent ]

Central Contacts and Locations

Central contacts

Deepa Raj, BA, MPH

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

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Health information communication
  • Behavioral intervention trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-15.