Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,412
- 试验地点
- 1
- 主要终点
- Proportion of youth participants with blood pressure <120/80 mmHg
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Music4Health Intervention (Behavioral)
结局指标
主要结局
Proportion of youth participants with blood pressure <120/80 mmHg
时间窗: 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.
Mean change in systolic blood pressure among caregiver participants
时间窗: 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.
Percent accuracy on a stroke knowledge and preparedness assessment
时间窗: 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.
Uptake of music-inspired hypertension/stroke prevention campaign (Music4Health) among youth and caregiver participants
时间窗: 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).
次要结局
- Intervention Acceptability(Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14)
- Intervention Fidelity(Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14)
- Intervention Reach(Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14)
- Intervention Sustainment(Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14)