- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03149380
Effectiveness of Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior
March 20, 2023 updated by: Weill Medical College of Cornell University
Evaluating the Effectiveness of Web-based Education Via Alzheimer's Universe (Www.AlzU.Org) on Knowledge and Behavior: A Randomized Trial
To evaluate the effectiveness of an online educational course on Alzheimer's disease (AD) prevention, treatment and caregiving.
Study Overview
Status
Withdrawn
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Medical College of Cornell University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Subjects will be given access to educational content on AD using interactive learning strategies
|
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.
|
|
Sham Comparator: Time-neutral control
Subjects will be given access to time-neutral general educational content on AD
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge of AD Preventative behaviors
Time Frame: 12 months
|
Knowledge is calculated as a positive change on multiple-choice questions about AD between pre vs. post-completion of educational material
|
12 months
|
|
Willingness to Engage in AD Preventative behaviors
Time Frame: 12 months
|
Willingness is calculated as a positive change on questionnaires evaluating AD-preventative behaviors between pre vs. post-completion of educational material
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Satisfaction
Time Frame: 12 months
|
The investigators will assess general satisfaction with the educational modules via pre vs post-intervention participant surveys
|
12 months
|
|
Behavioral Assessments
Time Frame: 12 months
|
The investigators will evaluate related behavioral assessments via pre vs post-intervention participant surveys
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard Isaacson, MD, Weill Medical College of Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2017
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
October 1, 2024
Study Registration Dates
First Submitted
January 13, 2017
First Submitted That Met QC Criteria
May 10, 2017
First Posted (Actual)
May 11, 2017
Study Record Updates
Last Update Posted (Actual)
March 22, 2023
Last Update Submitted That Met QC Criteria
March 20, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Disease Attributes
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- Late Onset Disorders
- Memory Disorders
Other Study ID Numbers
- 1311014539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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