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NCT Number: NCT07386535

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

High Blood Pressure Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypertension Nervous System Diseases Stroke Vascular Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music4Health Intervention

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Nigerian Institute of Medical Research
  • University of North Carolina, Chapel Hill

Registry information

Acronym: ITEST-BPStroke

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 4, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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