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Effectiveness 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Withdrawn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
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 13, 2017
Last Updated
March 20, 2023
Sponsor
Weill Medical College of Cornell University
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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

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