The Return of Cardiovascular Information Trial (RECITE) (RECITE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Curiosity; Cardiovascular Health Risk Communication
• Intervention / Treatment: Behavioral: Coarse health result information presentation; Behavioral: Granular health risk information presentation

Detailed Description

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.

Each cover letter will also include text recommending that participants view a set of short, publicly available educational YouTube videos, published by reputable health sources such as the American Heart Association and Mayo Clinic, related to heart health and lifestyle behaviors. These recommendations will appear immediately above the video links. Each participant's cover letter, printed or emailed and irrespective of study arm, will have QR codes/short links to the educational videos as described below. The information will be identical for each participant, but the order in which these links are displayed in each cover letter will be randomized to reduce position bias/primacy effect. Each video link will be embedded as a unique URL tied to the participant's de-identified study ID, which will allow the study to capture link clicks. Different QR codes/short-links will be provided in the cover letter to the first mailing (8 weeks after visit) and the second mailing (12 weeks after the visit).

Each video delivers practical, actionable guidance, such as:

• How to plan and structure daily routines to increase physical activity
• How to adopt and sustain healthy eating patterns
• Educational information regarding the following medication categories: diabetic medication, hypertension medication, and medication for high cholesterol.

Each participant will also get a follow-up phone call 16 weeks after their DHS study visit. The following questions will be asked:

• Did you get the full results report of your DHS visit? (Yes/No)

  1. If no, stop survey, ask participant "would you like us to resend it?" If yes, then we resend (after confirming preferred method/contact info)
  2. If yes, then continue with questions
• Did you understand the information provided to you? (Yes/No/I don't know/Refused)

• Did you make any health changes after receiving your results? (Yes/No/I don't know/Refused)

  1. If yes, what change did you make? (Exercise, diet, other (free text))

• Did the results report prompt a visit to your / healthcare provider? (Yes/No/I don't know/Refused)

• Did the results report prompt a new diagnosis of hypertension, diabetes, high cholesterol, or another condition by your healthcare provider? (Yes/No/I don't know/Refused)

  1. If yes, which? Check as many as apply: HTN, diabetes, high cholesterol, or other (free text)

• Were there any changes made to your medication as a result? (Yes/no/I don't know/refused)

Each subject will be identified solely by their pre-established and de-identified Dallas Heart Study (DHS) study ID, and no PHI will be utilized for this clinical trial. Each unique, de-identified participant ID will be linked to a unique, de-identified QR code and short link created using GitHub Enterprise secure software and internal tools. We track participant engagement through website clicks using a simple web-based system (GitHub + Google Sheets) to record when a selection of publicly available educational YouTube videos is accessed. Each video link directs participants to a secure webpage hosted in a GitHub repository and served via GitHub Pages, a widely used academic and open-source static web hosting service. Specifically, GitHub maintains a repository of static (fixed and unedited) HTML files, which are made publicly accessible on the internet as individual web links through GitHub Pages. Each file will correspond to each participant's de-identified study ID and video, each containing a small JavaScript component. This allows the links to be shared with participants either as QR codes or as URLs to directly type into a web browser. When a participant accesses a link, the system records minimal metadata (de-identified study ID, video identifier, and timestamp) and then immediately redirects the participant to the intended video content. Click metadata is transmitted securely and in real-time using encrypted HTTPS connections to a Google-hosted secure web app (via Google Apps Script), which writes the de-identified information to a private Google Sheet accessible only to authorized study personnel. We systematically create HTML files and QR codes for each HTML web link using Python libraries and each participant's de-identified study ID only. No protected health information, HIPAA identifiers, IP addresses, or device-level data are collected or stored as any part of this process. The use of this system is considered minimal risk, as it does not involve activity beyond standard web navigation and collects only limited, non-identifiable engagement data. Participants do not have access to the underlying code, data storage location, or logs, and cannot modify or view collected data. The system does not install software, use cookies, or track user behavior beyond the single link-click event.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deepa Raj, BA, MPH; Phone Number: 214-648-9256; Email: deepa.raj@utsouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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".	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported health behavior changes	1. Self-reported behavior changes assessed at the 4 month (16 week) follow up phone call: Participant self-report of seeing physician based off of health results; Participant self-report of making lifestyle changes based on their delivered health results	16 weeks after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcomes	Adverse clinical events, including hospitalizations, acute myocardial infarction, stroke, or syncope.	16 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Amil M Shah, MD, MPH, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Health information communication; Behavioral intervention trial
• Other Study ID Numbers: STU20260475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No