Indiana University Dementia Screening Trial (IU-CHOICE)
This study is not yet open for participant recruitment.
Verified September 2012 by Regenstrief Institute, IU Center for Aging Research
Sponsor:
Regenstrief Institute, IU Center for Aging Research
Collaborators:
Information provided by (Responsible Party):
Malaz Boustani, Regenstrief Institute, IU Center for Aging Research
ClinicalTrials.gov Identifier:
NCT01699503
First received: September 19, 2012
Last updated: September 30, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dementia Alzheimer's Disease Mild Cognitive Impairment |
Behavioral: Collaborative Dementia Care Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Screening |
| Official Title: | Indiana University Dementia Screening Trial: The IU CHOICE Study |
Resource links provided by NLM:
Further study details as provided by Regenstrief Institute, IU Center for Aging Research:
Primary Outcome Measures:
- Health Related Quality of Life (HRQOL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary outcome measure will be the HRQOL measured at baseline, 1, 6 and 12 months among the entire 4,000 enrollees. The study will use the 15-item Health Utility Index (HUI) to determine the subject's HRQOL. The HUI is a generic, utility-based HRQOL instrument applied in patients with a wide range of medical conditions. It has eight attributes: Vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. The individual health domain scores range from 0.00 (maximum impairment) to 1.00 (no impairment) and the multi-attribute (HUI index) scores, a multiplicative function of individual attribute levels, range from 0.36 to 1.00 with anchors 0.00 = dead and 1.00 = perfect health.
- Patient Health Questionnaire (PHQ-9) [ Time Frame: 1 month ] [ Designated as safety issue: No ]The PHQ-9 is a nine-item depression scale with a total score from 0 to 27. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of major depression.
- Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: 1 month ] [ Designated as safety issue: No ]The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21. It has a good internal consistency and test-retest reliability; as well as convergent, construct, criterion, procedural and factorial validity for the diagnosis of general anxiety disorder.
Secondary Outcome Measures:
- Health Care Utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]The study team will obtain consent at enrollment from all subjects for permission to review their medical records. The Indiana Network for Patient Care (a fully operational Health Information Exchange) will also be used to identify any episode of ambulatory or acute care that occurred within the following 12 months of enrollment date.
- Advanced Care Planning [ Time Frame: 12 months ] [ Designated as safety issue: No ]The study team will measure the subjects' advanced care planning including having power attorney for health care and/or financial affairs, having a living will, and having life and additional insurance policies at baseline and 12 months.
| Estimated Enrollment: | 4000 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: No Screening
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|
|
Experimental: Screening Group
Subjects who are randomized into the screening arm of the study will be screened by the MIS. Subjects with MIS score of less than 5 points will be referred to the Collaborative Dementia Care Program for a subsequent diagnostic assessment, counseling and management.
|
Behavioral: Collaborative Dementia Care Program
Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.
|
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.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adults age 65 and older;
- at least one office visit to their primary care physician within the previous year;
- no previous diagnosis of dementia or memory problem as determined by ICD-9 codes or the presence of prescription for anti-dementia medications (cholinesterase inhibitors or memantine);
- ability to consent to participate in the study; and
- ability to communicate in English
Exclusion Criteria:
- adults who are a permanent resident of a nursing facility;
- a serious mental illness such as bipolar disorder or schizophrenia as determined by the presence of related ICD-9 codes indicative of such an illness; or
- a pre-existing diagnosis of dementia or cognitive impairment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699503
Contacts
| Contact: Amie Frame, MPH | 317-423-5910 | amiframe@iupui.edu |
Locations
| United States, Indiana | |
| Wishard Health Services-Primary Care Clinics | Not yet recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| IU Health-Primary Care Clinics | Not yet recruiting |
| Indianapolis, Indiana, United States, 46202 | |
Sponsors and Collaborators
Regenstrief Institute, IU Center for Aging Research
Investigators
| Principal Investigator: | Malaz Boustani, MD, MPH | Regenstrief Institute, IU Center for Aging Research |
More Information
Publications:
| Responsible Party: | Malaz Boustani, Regenstrief Institute, IU Center for Aging Research Scientist, Regenstrief Institute, IU Center for Aging Research |
| ClinicalTrials.gov Identifier: | NCT01699503 History of Changes |
| Other Study ID Numbers: | R01-AG040220-01A1, 1R01AG040220-01A1 |
| Study First Received: | September 19, 2012 |
| Last Updated: | September 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Regenstrief Institute, IU Center for Aging Research:
|
Dementia Alzheimer's Disease Mild Cognitive Impairment Screening |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Cognition Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013