Indiana University Dementia Screening Trial (IU-CHOICE)
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|ClinicalTrials.gov Identifier: NCT01699503|
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : January 23, 2019
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer's Disease Mild Cognitive Impairment||Behavioral: Collaborative Dementia Care Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4005 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Indiana University Dementia Screening Trial: The IU CHOICE Study|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 22, 2017|
|Actual Study Completion Date :||November 22, 2017|
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.
- Health Related Quality of Life (HRQOL) [ Time Frame: 1 month, 6 months, 12 months ]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, 6 months, 12 months ]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. A higher score is associated with more severe depression.
- Generalized Anxiety Disorder Scale (GAD-7) [ Time Frame: 1 month, 6 months, 12 months ]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. A higher score is associated with more severe anxiety.
- Number of Participants With Health Care Utilization [ Time Frame: 12 months ]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.
- Number of Participants With an Advance Directive at 12 Months [ Time Frame: 12 months ]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 12 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699503
|United States, Indiana|
|IU Health-Primary Care Clinics|
|Indianapolis, Indiana, United States, 46202|
|Wishard Health Services-Primary Care Clinics|
|Indianapolis, Indiana, United States, 46202|
|IU Health Arnett Primary Care Clinics|
|West Lafayette, Indiana, United States, 47904|
|Principal Investigator:||Malaz Boustani, MD, MPH||Regenstrief Institute, Inc.|