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Clinical Trial Summary

The proposed study will integrate user-centered design, community engagement, and implementation science, with a randomized controlled trial (RCT), to develop, test, and collect implementation data on a youth-led hypertension (HTN) education digital badge. The badge will act as an electronic tool to guide youth through learning and then teaching adults on how to achieve better HTN control. Adults with HTN and youth will be recruited for user-centered design sessions to provide input in the development of a youth-led HTN education digital badge. The investigators will then recruit adult emergency department (ED) patients with uncontrolled HTN (blood pressure (BP) ≥130/80 mm Hg) who live with a youth (15-18 years old) and the youth themselves for a RCT. The adult plus youth dyad will be randomized to either: 1) intervention arm- 6-week youth-led HTN education digital badge at home- or 2) control arm- 6-week youth job readiness digital badge at home. In addition to the primary study outcome of adult BP change 2-months post-intervention, the investigator will collect secondary outcomes of HTN knowledge and youth self-efficacy, as well as implementation metrics of intervention acceptability, feasibility, and fidelity. Specific aims are: Aim 1: Create a youth-led HTN education digital badge by means of user-centered design methods and community engagement with adults with HTN and youth to obtain input on the contents of the digital badge prior to implementation. Aim 1a: The hypertension knowledge assessment being used in the study has not been used before on youth or Spanish-speaking populations, so the investigators will obtain feedback on the assessment from these groups. Aim 2: Evaluate the effectiveness of a youth-led HTN education digital badge intervention on the primary outcome of mean systolic BP and diastolic BP change in adults with uncontrolled HTN at 2-months post-intervention compared to the control group. Additionally, evaluate change in HTN knowledge and youth self-efficacy. Aim 3: Evaluate the implementation process of the youth-led HTN education digital badge by collecting qualitative and quantitative data on acceptability, feasibility, and fidelity of the intervention by participants.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05029687
Study type Interventional
Source Rutgers, The State University of New Jersey
Status Not yet recruiting
Phase N/A
Start date September 2021
Completion date March 2023

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