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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Hybrid Type II stepped-wedge cluster randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1412}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-10-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of youth participants with blood pressure <120/80 mmHg', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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.'}, {'measure': 'Mean change in systolic blood pressure among caregiver participants', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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.'}, {'measure': 'Percent accuracy on a stroke knowledge and preparedness assessment', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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.'}, {'measure': 'Uptake of music-inspired hypertension/stroke prevention campaign (Music4Health) among youth and caregiver participants', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Intervention Acceptability', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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.'}, {'measure': 'Intervention Fidelity', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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.'}, {'measure': 'Intervention Reach', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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.'}, {'measure': 'Intervention Sustainment', 'timeFrame': 'Months 0, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High blood pressure', 'Stroke', 'Hypertension', 'Young people', 'Adult caregivers', 'Prevention'], 'conditions': ['High Blood Pressure', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '21062776', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21091195', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31537347', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31086621', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': 'Akinyemi RO, Ovbiagele B, Adeniji OA, et al. Stroke in Africa: profile, progress, prospects and priorities. Nature Reviews Neurology. 2021;17(10):634-656.'}, {'type': 'BACKGROUND', 'citation': 'Sarfo FS, Ovbiagele B, Gebregziabher M, et al. Stroke among young West Africans: evidence from the SIREN (Stroke Investigative Research and Educational Network) large multisite case-control study. Stroke. 2018;49(5):1116-1122.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nYouth Participants\n\n* Aged 14-24 years\n* Reside in one of the 30 selected LGAs\n* Able to provide informed consent\n* Willing to participate in the M4H campaign\n\nCaregiver Participants\n\n* Aged ≥40 years\n* Identified as a caregiver (biological/surrogate parent, grandparent, or close relative)\n* Reside in the same household or have a caregiving relationship with eligible youth\n* Able to provide informed consent\n\nGeneral Eligibility for Dyads\n\n* Must be a youth-caregiver dyad (one youth and one caregiver)\n* Both members must consent to participate and complete baseline assessments\n* Reside in or be affiliated with the selected study LGAs\n\nExclusion Criteria:\n\nYouth Participants\n\n* Below 14 or above 24 years\n* Inability to provide informed consent\n* Unwilling to participate in intervention activities\n\nCaregiver Participants\n\n* Below 40 years of age\n* Not serving in a caregiver role to eligible youth\n* Inability to provide informed consent\n\nGeneral Eligibility for Dyads\n\n* Either party of the dyad does not meet the inclusion criteria\n* Refusal to participate or complete baseline assessments'}, 'identificationModule': {'nctId': 'NCT07386535', 'acronym': 'ITEST-BPStroke', 'briefTitle': 'Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Innovative Tools to Expand Music-Inspired Strategies for Blood Pressure and Stroke Prevention', 'orgStudyIdInfo': {'id': '202403128'}, 'secondaryIdInfos': [{'id': 'R01HL168766', 'link': 'https://reporter.nih.gov/quickSearch/R01HL168766', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Music4Health Intervention', '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.", 'interventionNames': ['Behavioral: Music4Health Intervention']}], 'interventions': [{'name': 'Music4Health Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Implementation Phase'], 'description': '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.', 'armGroupLabels': ['Music4Health Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yaba', 'state': 'Lagos', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Oliver C Ezechi, MD', 'role': 'CONTACT', 'email': 'oezechi@yahoo.co.uk', 'phone': '8033065683'}, {'name': 'Oliver C Ezechi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nigerian Institute of Medical Research', 'geoPoint': {'lat': 6.51395, 'lon': 3.37389}}], 'centralContacts': [{'name': 'Juliet Iwelunmor, PhD', 'role': 'CONTACT', 'email': 'ijuliet@wustl.edu', 'phone': '2405280123'}, {'name': 'Oliver C Ezechi, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Juliet Iwelunmor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Nigerian Institute of Medical Research', 'class': 'OTHER_GOV'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}