Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-29 @ 8:27 AM
Study NCT ID:
NCT01699503
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Indiana University Dementia Screening Trial
Sponsor:
Indiana University
Organization:
Study Overview
Official Title:
Indiana University Dementia Screening Trial: The IU CHOICE Study
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IU-CHOICE
Brief Summary:
The purpose of the study is to conduct a randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 older adults, cared for in typical, primary care practices.
Detailed Description:
The objective of this proposal is to address the question of whether the benefits outweigh the harms of routine screening for dementia among older adults in primary care when the screening program is coupled with primary care practices prepared to provide care for those who screen positive.
The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care.
Primary Specific Aim 1:
Test the impact of dementia screening on health-related quality of life of the patient at 12 months.
Primary Specific Aim 2:
Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms).
Secondary Aims: Estimate the cost effectiveness of dementia screening.
The specific aim of the study is to conduct a pragmatic randomized clinical trial assessing the harms and benefits of screening for dementia, compared to no screening for dementia, among 4,000 typical, older adults, cared for in typical, primary care practices, prepared to deliver best practices dementia care.
Primary Specific Aim 1:
Test the impact of dementia screening on health-related quality of life of the patient at 12 months.
Primary Specific Aim 2:
Test the impact of dementia screening on the mood and anxiety symptoms of patient at 1 month (i.e., primary potential harms).
Secondary Aims: Estimate the cost effectiveness of dementia screening.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01AG040220-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |