N/A
N=64
Youth-Led Intervention to Improve Blood Pressure
Hypertension · Adolescent Behavior · Health Knowledge, Attitudes, Practice
Bottom Line
View on ClinicalTrials.gov: NCT05029687 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: School Cohort: Hypertension Knowledge (Youth and Adult) — 17.5; 17.6; 17.9; 17.8 number of questions correct out of 21
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Youth-Led Hypertension Education Digital Intervention (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY School Cohort: Hypertension Knowledge (Youth and Adult) |
17.5; 17.6; 17.9; 17.8 | — |
| SECONDARY ED Cohort: Hypertension Knowledge (Youth and Adult) |
— | — |
| SECONDARY ED Cohort: Youth Self-efficacy |
— | — |
| SECONDARY School Cohort: Youth Self-efficacy |
8.2; 8.7; 8.9; 9.0; 8.8; 9.0 | — |
| SECONDARY ED Cohort: Adult Blood Pressure Self-care |
— | — |
| SECONDARY School Cohort: Adult Blood Pressure Self-care |
4.9; 5.2 | — |
| SECONDARY ED Cohort: Adult Self-efficacy to Manage HTN |
— | — |
| SECONDARY School Cohort: Adult Self-efficacy to Manage HTN |
8.1; 8.5 | — |
Summary
The proposed study will develop, test, and collect implementation data on a youth-led hypertension (HTN) education intervention, which 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 know (friend or family member) a youth (14-24 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. Due to challenges recruiting youth through adults in the ED, we will be adding a cohort to the study where we will recruit interested youth from New Brunswick Health Sciences Technology High School (NBHSTHS).
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 (for participants recruited from the ED). 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.
Eligibility Criteria
Inclusion Criteria
- Aim 1: Participants will be youth (15-18 years) and adults (18+ years old) with self-reported HTN diagnosis.
- Aim 1a: Participants will be youth (15-18 years) and Spanish-speaking adults (18+ years old) with self-reported HTN diagnosis.
- Aim 2: ED cohort: Eligible adult participants will be 18+ year old ED patients with a history of HTN and two high BP (≥ 130/80 mmHg) readings during their ED visit who know a 14-24 year old. The eligible youth participants (14-24- year-old) must have access to the internet or data plan and a smart phone or computer.
School cohort: Youth Eligibility: Any interested student at New Brunswick Health Sciences Technology High School.
Adult Eligibility: Adult (18+) (preference for adult who has been diagnosed with hypertension) with an existing relationship with the youth where it would be feasible to complete an online module together 1 hour per week for 6 weeks. Fluency in English or Spanish (youth must be able to speak fluent language).
- Aim 3: Everyone who consented to the RCT will be asked to complete a questionnaire, regardless of whether they completed the digital badge. Interested participants from the intervention arm will be recruited for the in-depth interviews.
Exclusion Criteria
- Aim 1: Age <15 years, inability to speak fluently in English or Spanish
- Aim 1a: Age <15 years, inability to speak fluently in English or Spanish
- Aims 2 and 3: ED cohort: Age <14 years, inability to speak fluently in English or Spanish, no access to the internet or a data plan and a smart phone or computer.
School cohort: People who cannot take part in the study are people who are not able to speak fluently in English or Spanish (youth and adult must be able to speak the same language), and youth with no access to the internet or a data plan and a smart phone or computer.
- Aim 3 (interviews): Participants from the control arm will not be eligible for the in-depth interviews.
Data sourced from ClinicalTrials.gov (NCT05029687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.