Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention (ITEST-BPStroke)

August 11, 2026 updated by: Washington University School of Medicine
Expanding evidence-based interventions for hypertension and stroke prevention among youth and their caregivers is crucial for meeting World Health Organization and Nigerian health goals. Innovative strategies are urgently needed to address the burden of hypertension and stroke in Nigeria, aiming to involve local communities, bridge generational gaps, and reduce health disparities. This study aims to determine the effect of a music-inspired intervention and campaign (Music4Health) designed by the community on blood pressure, stroke preparedness and intentions, and uptake of the intervention among youth-caregiver dyads in Nigeria.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a stepped-wedge cluster randomized controlled trial conducted in 30 local government areas in Nigeria. The aim of the study will be to test if the music-inspired intervention reduces blood pressure in caregivers ≥40 years old, maintains blood pressure in youth 14-24 years old, and improves stroke preparedness among youth and caregivers. Sites will be randomly assigned to one of four waves, which will deliver the intervention to a longitudinal cohort of youth-caregiver dyads, spaced one month between each wave. The control period will last three months and include no intervention, and the intervention period will last three months for each wave and will include three music listening sessions (Music4Health Day) spaced one month apart. Participants will be recruited and enrolled in the trial through various methods, including community outreach, referrals, and social media. Participants will be invited to attend three community-based Music4Health Days on predetermined dates (schedule based on randomized intervention waves) and will be asked to return to the intervention site for follow-up data collection, including blood pressure measurements and validated questionnaires. The Music4Health Day intervention will include a listening session of a music video with lyrics designed to improve knowledge and awareness of high blood pressure and stroke preparedness. During Music4Health Day, music ambassadors will also share personal experiences to promote health messages and foster community engagement. Following the intervention period, the investigators will follow the cohort for six months after the intervention period to collect outcome data from each participant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Oliver C Ezechi, MD

Study Locations

  • Nigeria
    • Lagos
      • Yaba, Lagos, Nigeria
        • Nigerian Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Youth Participants

  • Aged 14-24 years
  • Reside in one of the 30 selected LGAs
  • Able to provide informed consent
  • Willing to participate in the M4H campaign

Caregiver Participants

  • Aged ≥40 years
  • Identified as a caregiver (biological/surrogate parent, grandparent, or close relative)
  • Reside in the same household or have a caregiving relationship with eligible youth
  • Able to provide informed consent

General Eligibility for Dyads

  • Must be a youth-caregiver dyad (one youth and one caregiver)
  • Both members must consent to participate and complete baseline assessments
  • Reside in or be affiliated with the selected study LGAs

Exclusion Criteria:

Youth Participants

  • Below 14 or above 24 years
  • Inability to provide informed consent
  • Unwilling to participate in intervention activities

Caregiver Participants

  • Below 40 years of age
  • Not serving in a caregiver role to eligible youth
  • Inability to provide informed consent

General Eligibility for Dyads

  • Either party of the dyad does not meet the inclusion criteria
  • Refusal to participate or complete baseline assessments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music4Health Intervention
Each of the 30 local government areas (LGAs) will be randomly allocated using block randomization to one of the four waves, with 7-8 LGAs allocated to each wave. All waves will begin with a control period with the first wave commencing the intervention period three months following the study start and each subsequent wave commencing one month following the start date of the previous wave's intervention period. Each wave's intervention period will last three months.
Behavioral: Music4Health Intervention
The intervention period will include three Music4Health Day community events. Music4Health Day will adapt content from open call submissions and apprenticeships with community-based teams to meet the music preferences of youth and their caregivers. The events will focus on managing blood pressure, preventing strokes, and stroke preparedness through music-inspired strategies, utilizing rhythms and lyrics. Each Music4Health Day event will include a listening session of a music video with lyrics designed to improve knowledge and awareness of high blood pressure and stroke preparedness. Participants will be provided with MP3 files and YouTube video links containing music, videos, visuals, and health messages. Participants will listen to the intervention at the events and also at their convenience on their mobile phones, followed by weekly text reminders. During the events, music ambassadors will also share personal experiences to promote health messages and foster community engagement.
Other Names:
  • Implementation Phase

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Uptake of music-inspired hypertension/stroke prevention campaign (Music4Health) among youth and caregiver participants
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Uptake of the campaign is defined as the absolute number, proportion, and representativeness of participants who participate in the campaign (i.e., attend listening sessions).
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Proportion of youth participants with blood pressure <120/80 mmHg
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Systolic and diastolic blood pressure among youth participants will be measured three times at each time point using a digital sphygmomanometer by trained community health extension workers. The mean systolic and diastolic blood pressure from the three measures will be calculated for each time point. We will calculate the proportion of youth participants with a mean systolic and diastolic blood pressure <120/80 mmHg for each time point.
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Mean change in systolic blood pressure among caregiver participants
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Systolic blood pressure among caregiver participants will be measured three times at each time point using a digital sphygmomanometer by trained community health extension workers. The mean systolic blood pressure from the three measures will be calculated for each time point. Change in systolic blood pressure will be calculated as the difference in systolic blood pressure from baseline (month 0) to each endpoint.
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Percent accuracy on a stroke knowledge and preparedness assessment
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Stroke knowledge and preparedness will be assessed using a self-administered 13-item multiple-choice tool assessing knowledge of stroke symptoms, appropriate responses to stroke symptoms, and the ability to accurately identify a stroke in case examples. This knowledge assessment tool is a modified version of a tool used in the HipHop Stroke Study.
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intervention Acceptability
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
This will measure the ITEST BP/Stroke campaign. Measured using the Acceptability of Intervention Measure (AIM), Cronbach's alpha = 0.85. The four item measure participants' satisfaction, important implementation outcomes that are often considered a "leading indicator" of implementation success. The subscales are rated on a 5-point Likert scale, 1 to 5, with higher scores indicating higher acceptability. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Intervention Fidelity
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
This will measure the evidence that the core ITEST BP/Stroke campaign components were delivered as intended in relation to the study protocol, consistency of implementation across 30 study sites (LGAS). This will be assessed both quantitatively and qualitatively using the following four dimensions: (1) Frequency: number of intervention-related interactions; (2) Duration: length of each component of the intervention; (3) Content: the knowledge or behavioral change the music-inspired intervention seeks to deliver to the youth and caregiver dyads; and (4) Coverage: the number of youth/caregiver dyads who receive the music-inspired intervention as intended over the number of participants who are enrolled. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Intervention Reach
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
The proportion of eligible youth/caregiver dyads reached versus the total target population. Measured as 1) the participation rate among eligible participants; 2) the representativeness of participants based on demographic and health characteristics. The reasons given for declining to participate will also be assessed. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
Intervention Sustainment
Time Frame: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14
This will measure the maintenance of the BP/Stroke campaign using the Stages of Implementation Completion (SIC), an eight-stage assessment tool will be used to assess the sustainment of the intervention. This tool delineates the start of implementation. This will be measured using a self-administered questionnaire and in-depth interviews facilitated by trained research staff.
Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Chapel Hill
Nigerian Institute of Medical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juliet Iwelunmor, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 26, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202403128
  • R01HL168766 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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