Viewing Study NCT04482036



Ignite Creation Date: 2024-05-06 @ 2:59 PM
Last Modification Date: 2024-10-26 @ 1:40 PM
Study NCT ID: NCT04482036
Status: TERMINATED
Last Update Posted: 2023-09-01
First Post: 2020-05-15

Brief Title: The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic MCI and AD MOMENT Study
Sponsor: Indiana University
Organization: Indiana University

Study Overview

Official Title: The MObile AssessMENT of Behavioral and Psychological Symptoms of Dementia in Amnestic Mild Cognitive Impairment and Alzheimers Disease MOMENT Study A Randomized Controlled Trial
Status: TERMINATED
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: The Principle Investigator changed careers and relinquished their NIA funded career development award which funded the MOMENT Study Career development awards are not transferable Thus the study was terminated prematurely
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: MOMENT
Brief Summary: The purpose of this research study is to learn whether it is possible and useful for caregivers to report behavioral or psychological symptoms of people with mild memory problems or Alzheimers disease through a smartphone mobile application The investigators believe that monitoring these symptoms and having a tool like a mobile application can provide quicker accessibility to the patients clinical care team which could improve care for patients and caregivers

These types of symptoms found in patients with mild memory problems or Alzheimers disease are any type of psychiatric symptoms or abnormal behaviors one might develop as the result of these brain illnesses Examples of psychological and behavioral symptoms are depression anxiety insomnia irritability agitation and hallucinations These symptoms differ from regular psychiatric symptoms because they are caused by mild memory problems or Alzheimers disease AD These symptoms can cause a lot of distress for patients and caregivers and can lead to greater use of healthcare services
Detailed Description: As a part of this research study the patient and caregiver will undergo randomization like flipping a coin to assign the patient and caregiver to one of two research study groups The patient and the partnered caregiver will join the same group The group will either receive 1 three in-person assessments on symptoms and behaviors that the patient may experience and a mobile application that will send surveys to the caregiver in order to rate the presence severity and stress caused by these symptoms and behaviors or 2 three in-person assessments on symptoms and behaviors that the patient may experience and no mobile application The outcomes of these surveys and assessments will then be shared with the patients clinical team

If the caregiver is assigned to the group that receives the mobile application they will receive the surveys either weekly or monthly After each month of completing the surveys the frequency will change Depending on feedback from the first 10 participants the investigators may modify the survey rate to happen more than weekly

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1K23AG059914-01A1 NIH None httpsreporternihgovquickSearch1K23AG059914-01A1