Youth-Led Intervention to Improve Blood Pressure

A Youth-Led Digital Education Intervention to Improve Blood Pressure for Hypertensive Adults Who Present to the Emergency Department

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Health Knowledge, Attitudes, Practice; Adolescent Behavior
• Intervention / Treatment: Behavioral: Youth-Led Hypertension Education Digital Intervention

Detailed Description

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 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. For this new cohort of the study, we will recruit interested youth from New Brunswick Health Sciences Technology High School (NBHSTHS). Students will be asked to pair themselves with an adult (18+) (preference for adult who has been diagnosed with hypertension, but not mandatory) with an existing relationship with the student where it would be feasible to complete an online module together 1 hour per week for 6 weeks. The adult must be fluent in English or Spanish and the student must be able to speak the fluent language of the adult. We will evaluate the youth-led digital hypertension (HTN) education intervention- an electronic tool to guide youth through learning and then teaching and supporting adults on how to control hypertension (for adults with hypertension) and how to avoid it (for adults without hypertension). Outcomes of interest are HTN knowledge, confidence in HTN management, and health behavior changes in participants, which will be obtained through pre- and post- intervention assessments. We will also be exploring outcomes of participant acceptability, feasibility, and fidelity of the intervention.

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED Cohort: Hypertension Knowledge (Youth and Adult)	Using assessment adapted from Williams et al.'s 1998 hypertension knowledge tool	Baseline and 1 week and 2 months post-intervention completion
ED Cohort: Youth Self-efficacy	Using a 3-item investigator-created assessment tool on confidence in managing high blood pressure	Baseline and 1 week and 2 months post-intervention completion
School Cohort: Youth Self-efficacy	To measure youth confidence helping an adult manage hypertension, investigators created a 3-item assessment from 1 (not at all confident) to 10 (totally confident), on confidence to 1) teach, 2) encourage, and 3) help an adult lower their BP. The outcome measure represents the mean for each of the three items.	At end of 6-week intervention and 1 month post-6-week intervention
ED Cohort: Adult Blood Pressure Self-care	Using the Adult Blood Pressure Self-Care Scale (Warren-Findlow et al.)	Baseline and 1 week and 2 months post-intervention completion
School Cohort: Adult Blood Pressure Self-care	Mean using the 10-question Adult Blood Pressure Self-Care Scale (Peters & Templin, 2010), which states: "In general, how often are the following statements true about you?" on a scale of 1-Never to 7-Always for self-reported frequency of behaviors (e.g. diet, exercise) that control BP. (e.g.: "I am eating a low-salt diet each day.")	At end of 6-week intervention and 1 month post-6-week intervention
ED Cohort: Adult Self-efficacy to Manage HTN	Using Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.)	Baseline and 1 week and 2 months post-intervention completion
School Cohort: Adult Self-efficacy to Manage HTN	Mean using the 5-question Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.) which asks about confidence in managing BP control behaviors on a scale of 1-not at all confident to 10-totally confident.	At end of 6-week intervention and 1 month post-6-week intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
For ED Cohort: Blood Pressure Change	Change in systolic and diastolic adult blood pressure (in mm Hg)	Baseline to 1 week and 2 months post-intervention completion

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Behavior; Adolescent Behavior
• Other Study ID Numbers: Pro2021000126; UL1TR003017 (U.S. NIH Grant/Contract)

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