Youth-Led Intervention to Improve Blood Pressure

NCT05029687 | Completed Results

• 2 other identifiers: Pro2021000126UL1TR003017
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Health Knowledge, Attitudes, Practice; Adolescent Behavior

Outcome Measures

Primary Outcomes (1)

• School Cohort: Hypertension Knowledge (Youth and Adult)

  Using 21-question assessment adapted from Williams et al.'s 1998 hypertension knowledge tool. Results reported are the mean number of questions correct out of 21.

  At end of 6-week intervention, and 1 month post-6-week intervention

Secondary Outcomes (7)

• ED Cohort: Hypertension Knowledge (Youth and Adult)

  Baseline and 1 week and 2 months post-intervention completion

• ED Cohort: Youth Self-efficacy

  Baseline and 1 week and 2 months post-intervention completion

• School Cohort: Youth Self-efficacy

  At end of 6-week intervention and 1 month post-6-week intervention

• ED Cohort: Adult Blood Pressure Self-care

  Baseline and 1 week and 2 months post-intervention completion

• School Cohort: Adult Blood Pressure Self-care

  At end of 6-week intervention and 1 month post-6-week intervention

Other Outcomes (1)

• For ED Cohort: Blood Pressure Change

  Baseline to 1 week and 2 months post-intervention completion

Study Arms (1)

Intervention Arm

EXPERIMENTAL

The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.

Behavioral: Youth-Led Hypertension Education Digital Intervention

Interventions

Youth-Led Hypertension Education Digital Intervention BEHAVIORAL

The intervention is a youth-led HTN education digital intervention, which will be comprised of a 6-week playlist of one module per week comprising the playlist. Youth will learn from the module and will teach the adult in their dyad about hypertension education in each week's themed module.

Intervention Arm

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Hypertension; Adolescent Behavior; Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sara Heinert, PhD, MPH
• Organization: Rutgers University

sara.heinert@rutgers.edu

732-235-7872

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Emergency Medicine

Model Details: Study transitioned from a randomized controlled trial to a single group study. The total participants enrolled in the trial include all aspects of the study (including qualitative focus groups and interviews).

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 31, 2021
• Study Start: October 31, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)