Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:56 PM
Study NCT ID:
NCT07386535
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITEST-BPStroke
Brief 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. 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL168766 | NIH | None | https://reporter.nih.gov/quic… | View |