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High Blood PressureITEST-BPStrokeNCT07386535

Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention

A study testing Music4Health Intervention in people with High Blood Pressure and Stroke, run by Washington University School of Medicine at 1 site in Nigeria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
High Blood Pressure, Stroke
What is being tested?
Music4Health Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,412 participants
Where
1 siteNigeria
Study dates
1 Feb 2026to 26 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Nigeria1 site

  • Nigerian Institute of Medical Research

    Yaba, Lagos

Other trials in Nigeria

About this study

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.

Read the 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.

Being tested
Music4Health Intervention
Keywords
High blood pressure, Stroke, Hypertension, Young people, Adult caregivers, Prevention
Medical subject headings
Hypertension, Stroke

What participants receive

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

  • Music4Health InterventionBehavioural

    Also called Implementation Phase

    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.

Study groups in NCT07386535
Study groupRoleWhat they receive
Music4Health InterventionExperimentalEach 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.
Receives: Behavioral: Music4Health Intervention

What is being measured

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

  1. Proportion of youth participants with blood pressure <120/80 mmHg

    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.

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  2. Mean change in systolic blood pressure among caregiver participants

    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.

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  3. Percent accuracy on a stroke knowledge and preparedness assessment

    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.

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  4. Uptake of music-inspired hypertension/stroke prevention campaign (Music4Health) among youth and caregiver participants

    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).

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

Secondary outcomes (4)

  1. Intervention Acceptability

    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.

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  2. Intervention Fidelity

    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.

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  3. Intervention Reach

    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.

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

  4. Intervention Sustainment

    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.

    Measured: Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14

Timeline

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

  1. First posted4 Feb 2026
  2. Study start1 Feb 2026
  3. Primary completion26 Oct 2027 (estimated)
  4. Study completion26 Oct 2027 (estimated)

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
Prevention
Allocation
Not applicable
Intervention model
Sequential
Model description
Hybrid Type II stepped-wedge cluster randomized trial
Masking
None (open label)
Enrolment
1,412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07386535
Sponsor's protocol ID
202403128
Other IDs
R01HL168766
Acronym
ITEST-BPStroke
Status last verified
Aug 2026
First submitted
27 Jan 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Trappe HJ. The effects of music on the cardiovascular system and cardiovascular health. Heart. 2010 Dec;96(23):1868-71. doi: 10.1136/hrt.2010.209858.

    PubMed 21062776

  • Braveman P, Egerter S, Williams DR. The social determinants of health: coming of age. Annu Rev Public Health. 2011;32:381-98. doi: 10.1146/annurev-publhealth-031210-101218.

    PubMed 21091195

  • Bigna JJ, Noubiap JJ. The rising burden of non-communicable diseases in sub-Saharan Africa. Lancet Glob Health. 2019 Oct;7(10):e1295-e1296. doi: 10.1016/S2214-109X(19)30370-5. No abstract available.

    PubMed 31537347

  • Ajayi S, Adebiyi A, Kadiri S. Increased urinary sodium excretion is associated with systolic blood pressure in first degree relatives of hypertensive patients in Ibadan, Southwestern Nigeria. Pan Afr Med J. 2018 Nov 9;31:168. doi: 10.11604/pamj.2018.31.168.16611. eCollection 2018.

    PubMed 31086621

  • Akinyemi RO, Ovbiagele B, Adeniji OA, Sarfo FS, Abd-Allah F, Adoukonou T, Ogah OS, Naidoo P, Damasceno A, Walker RW, Ogunniyi A, Kalaria RN, Owolabi MO. Stroke in Africa: profile, progress, prospects and priorities. Nat Rev Neurol. 2021 Oct;17(10):634-656. doi: 10.1038/s41582-021-00542-4. Epub 2021 Sep 15.

    PubMed 34526674

  • Sarfo FS, Ovbiagele B, Gebregziabher M, Wahab K, Akinyemi R, Akpalu A, Akpa O, Obiako R, Owolabi L, Jenkins C, Owolabi M; SIREN. Stroke Among Young West Africans: Evidence From the SIREN (Stroke Investigative Research and Educational Network) Large Multisite Case-Control Study. Stroke. 2018 May;49(5):1116-1122. doi: 10.1161/STROKEAHA.118.020783. Epub 2018 Apr 4.

    PubMed 29618553

Questions about this trial

What is this clinical trial studying?

A study testing Music4Health Intervention in people with High Blood Pressure and Stroke, run by Washington University School of Medicine at 1 site in Nigeria.

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 14 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. 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 Nigeria. 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?

This study is still under way. Results are not available in the source record yet.

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?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07386535, which also lists 6 linked publications.

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 12 Aug 2026.

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