The Return of Cardiovascular Information Trial (RECITE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Attendance of the Dallas Heart Study-4 clinical visit
Participant confirms ability and willingness to utilize short links/QR codes during clinical visit
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Coarse health result information presentation
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Arm 1, Coarse Health Risk FormatExperimental treatment 1 intervention
Group B: Arm 2, Granular Health Risk FormatExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
QR Code use for Educational Health Videos
Number of clicks per link/QR code in the 3 weeks after Result Letter #1 sent
Time frame
3 weeks after first health results letter is sent2
Change in Educational Health Video Engagement
Change in number of clicks per link/QR code in the 3 weeks after Result Letter #2
Time frame
3 weeks following the second result letter is sentSecondary outcomes
1
Self-reported health behavior changes
1\. Self-reported behavior changes assessed at the 4 month (16 week) follow up phone call: 1. Participant self-report of seeing physician based off of health results 2. Participant self-report of making lifestyle changes based on their delivered health results
Time frame
16 weeks after randomizationOther outcomes
1
Incidence of adverse events
This assessment will include adverse clinical events, including hospitalizations, acute myocardial infarction, stroke, or syncope which are assessed by annual health survey (phone/redcap survey-based), and if an event is endorsed, the participant is contacted with a request to receive their medical record. If they agree, the records are collected and the cardiologists will independently adjudicate the events as being definite/probable/indeterminate events. Additionally, each year Dallas Fort-Worth (DFW) hospital council foundation and CDC national death index data are queried for inpatient hospitalizations in the metroplex and mortality data, respectively.
Time frame
on an annual basis from the time participants enroll in the Dallas Heart Study cohort until patient expiresSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Johns Hopkins University
Collaborator
Source ClinicalTrials.gov