Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge
Primary Purpose
Dementia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Old SCHOOL Hip-Hop
My Plate
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Dementia, Schools, Nutrition, Health
Eligibility Criteria
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.
Sites / Locations
- Columbia University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Intervention
Arm Description
School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.
School population with the Old SCHOOL Hip-Hop program.
Outcomes
Primary Outcome Measures
Change in Dementia Symptom and Response Knowledge Assessment Score
An instrument with multiple choice questions to assess knowledge of recognition of 6 key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03284112
Brief Title
Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge
Official Title
Old SCHOOL Hip-Hop: A Randomized Controlled Trial to Improve Alzheimer's Disease Knowledge
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to evaluate the knowledge of parents and children with respect to dementia symptoms, risk factors, and response before and after an interactive dementia education program that uses music and dance to enhance a health education curriculum at 1-week and 3-months after the intervention.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Schools, Nutrition, Health
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
School population without the Old SCHOOL Hip-Hop program, but with the My Plate program.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
School population with the Old SCHOOL Hip-Hop program.
Intervention Type
Behavioral
Intervention Name(s)
Old SCHOOL Hip-Hop
Other Intervention Name(s)
OSHH Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
My Plate
Other Intervention Name(s)
My Plate nutrition program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Dementia Symptom and Response Knowledge Assessment Score
Description
An instrument with multiple choice questions to assess knowledge of recognition of 6 key signs/symptoms and ability to formulate the correct action plan in response to recognizing dementia.
Time Frame
Baseline, 1 week, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Noble, MD
Phone
212-342-4126
Email
jn2054@columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Noble, MD
Organizational Affiliation
Assistant Professor of Neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Noble, MD
Phone
212-342-4126
Email
jn2054@columbia.edu
First Name & Middle Initial & Last Name & Degree
James Noble, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge
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