Back to resultsEffectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior
Primary Purpose
Alzheimer Disease, Alzheimer Disease, Late Onset, Memory Loss
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based education
Sponsored by
About this trial
This is an interventional prevention trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- greater than or equal to 14 years old with a friend, family member or acquaintance with Alzheimer's disease or memory loss, OR a person diagnosed with mild memory loss (including mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease), OR an AD caregiver, OR healthcare providers, OR a medical student, college student or high school student.
Exclusion Criteria:
- < 14 years old, OR diagnosis of moderate or severe Alzheimer's disease
Sites / Locations
- Weill Medical College of Cornell University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
Time-neutral control
Arm Description
Subjects will be given access to educational content on AD using interactive learning strategies
Subjects will be given access to time-neutral general educational content on AD
Outcomes
Primary Outcome Measures
Knowledge of AD Preventative behaviors
Knowledge is calculated as a positive change on multiple-choice questions about AD between pre vs. post-completion of educational material
Willingness to Engage in AD Preventative behaviors
Willingness is calculated as a positive change on questionnaires evaluating AD-preventative behaviors between pre vs. post-completion of educational material
Secondary Outcome Measures
Participant Satisfaction
The investigators will assess general satisfaction with the educational modules via pre vs post-intervention participant surveys
Behavioral Assessments
The investigators will evaluate related behavioral assessments via pre vs post-intervention participant surveys
Full Information
NCT ID
NCT03149380
First Posted
January 13, 2017
Last Updated
March 20, 2023
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03149380
Brief Title
Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior
Official Title
Evaluating the Effectiveness of Web-based Education Via Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI withdrawn
Study Start Date
January 2017 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effectiveness of an online educational course on Alzheimer's disease (AD) prevention, treatment and caregiving.
Detailed Description
Alzheimer's Universe (www.AlzU.org) was created to provide online education about Alzheimer's disease (AD), with a focus on family members of people with AD, people with mild cognitive impairment due to AD and mild AD, caregivers, healthcare providers, medical students, college students and high school students. The website provides evidence-based courses with interactive lessons and activities that have been shown to increase knowledge about AD, willingness to participate in an AD prevention clinical trial, and intent to make specific lifestyle changes in effort to reduce AD risk.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Alzheimer Disease, Late Onset, Memory Loss, Patient Education as Topic
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects will be given access to educational content on AD using interactive learning strategies
Arm Title
Time-neutral control
Arm Type
Sham Comparator
Arm Description
Subjects will be given access to time-neutral general educational content on AD
Intervention Type
Behavioral
Intervention Name(s)
Web-based education
Intervention Description
The investigators will utilize interactive lessons and activities to educate about Alzheimer's disease prevention, treatment and caregiving, with focus on evidence-based lifestyle and nutritional recommendations that have been associated with delaying cognitive decline.
Primary Outcome Measure Information:
Title
Knowledge of AD Preventative behaviors
Description
Knowledge is calculated as a positive change on multiple-choice questions about AD between pre vs. post-completion of educational material
Time Frame
12 months
Title
Willingness to Engage in AD Preventative behaviors
Description
Willingness is calculated as a positive change on questionnaires evaluating AD-preventative behaviors between pre vs. post-completion of educational material
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Participant Satisfaction
Description
The investigators will assess general satisfaction with the educational modules via pre vs post-intervention participant surveys
Time Frame
12 months
Title
Behavioral Assessments
Description
The investigators will evaluate related behavioral assessments via pre vs post-intervention participant surveys
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
greater than or equal to 14 years old with a friend, family member or acquaintance with Alzheimer's disease or memory loss, OR a person diagnosed with mild memory loss (including mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease), OR an AD caregiver, OR healthcare providers, OR a medical student, college student or high school student.
Exclusion Criteria:
< 14 years old, OR diagnosis of moderate or severe Alzheimer's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Isaacson, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.AlzU.org/
Description
Direct hyperlink to Alzheimer's Universe website
Learn more about this trial
Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior
We'll reach out to this number within 24 hrs