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

The Washington University

Status: Not yet enrolling

Conditions: High Blood Pressure; Stroke

Treatments: Behavioral: Music4Health Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07386535

202403128

R01HL168766 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,412 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,412 participants in 1 patient group

Music4Health Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Music4Health Intervention