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HypertensionNCT05029687

Youth-Led Intervention to Improve Blood Pressure

A study testing Youth-Led Hypertension Education Digital Intervention in people with Hypertension and Adolescent Behavior, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
What is being tested?
Youth-Led Hypertension Education Digital Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteUnited States
Study dates
31 Oct 2021to 30 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: 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:

Read more

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.

Read the 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.

Being tested
Youth-Led Hypertension Education Digital Intervention
Medical subject headings
Hypertension, Adolescent Behavior, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Youth-Led Hypertension Education Digital InterventionBehavioural

    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.

Study groups in NCT05029687
Study groupRoleWhat they receive
Intervention ArmExperimentalThe 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.
Receives: Behavioral: Youth-Led Hypertension Education Digital Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  1. ED Cohort: Hypertension Knowledge (Youth and Adult)

    Using assessment adapted from Williams et al.'s 1998 hypertension knowledge tool

    Measured: Baseline and 1 week and 2 months post-intervention completion

  2. ED Cohort: Youth Self-efficacy

    Using a 3-item investigator-created assessment tool on confidence in managing high blood pressure

    Measured: Baseline and 1 week and 2 months post-intervention completion

  3. 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.

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

  4. ED Cohort: Adult Blood Pressure Self-care

    Using the Adult Blood Pressure Self-Care Scale (Warren-Findlow et al.)

    Measured: Baseline and 1 week and 2 months post-intervention completion

  5. 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.")

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

  6. ED Cohort: Adult Self-efficacy to Manage HTN

    Using Adult Self-Efficacy to Manage Hypertension Scale (Warren-Findlow et al.)

    Measured: Baseline and 1 week and 2 months post-intervention completion

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2021
  2. Study start31 Oct 2021
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05029687
Sponsor's protocol ID
Pro2021000126
Other IDs
UL1TR003017
Status last verified
Dec 2025
First submitted
19 Aug 2021
Last updated
30 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Youth-Led Hypertension Education Digital Intervention in people with Hypertension and Adolescent Behavior, run by Rutgers, The State University of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

School Cohort: Hypertension Knowledge (Youth and Adult) (time frame: At end of 6-week intervention, and 1 month post-6-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

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