- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284112
Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge
Old SCHOOL Hip-Hop: A Randomized Controlled Trial to Improve Alzheimer's Disease Knowledge
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Public awareness of cardinal Alzheimer's disease (AD) symptoms remains low. Adults often underestimate personal dementia risk; minority populations are more likely to have low dementia literacy and be unaware of it. Cultural dementia belief in minority groups are complex and pose barriers to diagnosis, with dementia symptoms being considered a part of normal aging, or that discussion may be taboo even when recognized. A key barrier to timely AD diagnosis in African Americans is delayed physician contact, often years-long, following the onset of first symptoms. Despite studies demonstrating that dementia concepts first develop in elementary school periods, apart from our work, no dementia awareness programs focus on children. This intervention therefore addresses a major gap regarding optimal approaches for shifting cultural perceptions of dementia in low-income minority populations and reducing barriers to its timely diagnosis.
All R01 aims have been completed in this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 4th and 5th-grade children (ages 9-11y) and their parents (age > 20 years).
- Selected New York City public schools with similar socio-demographic composition.
Exclusion Criteria:
- Schools have already received pilot OSHH and the U.S. Department of Health and Human Services (HHS) programming.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Control
School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.
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The program selected for the control arm, "My Plate," will address nutrition, physical activity, and obesity education.
This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive.
Trained facilitators will conduct "My Plate" as an entry point for the USDA's My Plate nutrition program.
Students will learn about My Plate across the 3-day one-hour-a-day program.
Other Names:
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Experimental: Intervention
School population with the Old SCHOOL Hip-Hop program.
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A school-based intervention called "Old S.C.H.O.O.L. Hip-Hop" (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions).
The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OSHH Program Effectiveness of Educating Parents at 1-week and 3-months After the Intervention Using ASK-AD 7
Time Frame: Baseline (1 week up to 15 weeks prior to Intervention Day 1), 1-week post-intervention (1 week up to 13 weeks post-Intervention Day 3, but always before 3-month intervention), and 3-months post-intervention (10 to 24 weeks post-intervention Day 1)
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OSHH Program effectiveness of educating parents at 1-week post and 3-months post intervention using a 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions).
Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome.
|
Baseline (1 week up to 15 weeks prior to Intervention Day 1), 1-week post-intervention (1 week up to 13 weeks post-Intervention Day 3, but always before 3-month intervention), and 3-months post-intervention (10 to 24 weeks post-intervention Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OSHH Program Effectiveness of Educating Students at Immediate-post and 3-months Post the Intervention Using ASK-AD 7
Time Frame: Immediately before intervention began (On Day 1 of programming), Immediately post intervention (Day 3 of programming), 3-months post intervention (6 up to 20 weeks post Day 1 of programming)
|
OSHH Program effectiveness of educating students immediately-post and 3-months post the intervention using a 7-item scale: ASK-AD 7 (Assess Symptoms and Knowledge of Alzheimer's Disease - 7 Questions).
Minimum value is 0 and maximum value is 7. Higher scores indicate greater number of questions answered correctly, indicating a better outcome.
|
Immediately before intervention began (On Day 1 of programming), Immediately post intervention (Day 3 of programming), 3-months post intervention (6 up to 20 weeks post Day 1 of programming)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Noble, MD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAR5473
- 5R01AG054536 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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