IU-CHOICE: Indiana University Dementia Screening Trial

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01699503
• Collaborator: National Institutes of Health (NIH) (NIH), National Institute on Aging (NIA) (NIH)
• Enrollment: 4,005
• Locations: 3
• Arms: 2
• Duration (Months): 61.7
• Patients Per Site: 1335
• Patients Per Site Per Month: 21.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia; Alzheimer's Disease; Mild Cognitive Impairment	Behavioral: Collaborative Dementia Care Program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4005 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Indiana University Dementia Screening Trial: The IU CHOICE Study
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Nov 22, 2017
• Actual Study Completion Date: Nov 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Health Related Quality of Life (HRQOL) [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.

2. Patient Health Questionnaire (PHQ-9) [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.

3. Generalized Anxiety Disorder Scale (GAD-7) [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.

Secondary Outcome Measures

1. Number of Participants With Health Care Utilization [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.

2. Number of Participants With an Advance Directive at 12 Months [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	IU Health-Primary Care Clinics	Indianapolis	Indiana	United States	46202
2	Wishard Health Services-Primary Care Clinics	Indianapolis	Indiana	United States	46202
3	IU Health Arnett Primary Care Clinics	West Lafayette	Indiana	United States	47904

Sponsors and Collaborators

• Indiana University
• National Institutes of Health (NIH)
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2013

More Information

Publications

• Boustani M, Perkins AJ, Monahan P, Fox C, Watson L, Hopkins J, Fultz B, Hui S, Unverzagt FW, Callahan CM, Hendrie HC. Measuring primary care patients' attitudes about dementia screening. Int J Geriatr Psychiatry. 2008 Aug;23(8):812-20. doi: 10.1002/gps.1983.
• Boustani M, Peterson B, Hanson L, Harris R, Lohr KN; U.S. Preventive Services Task Force. Screening for dementia in primary care: a summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2003 Jun 3;138(11):927-37. Review.
• Boustani MA, Justiss MD, Frame A, Austrom MG, Perkins AJ, Cai X, Sachs GA, Torke AM, Monahan P, Hendrie HC. Caregiver and noncaregiver attitudes toward dementia screening. J Am Geriatr Soc. 2011 Apr;59(4):681-6. doi: 10.1111/j.1532-5415.2011.03327.x. Epub 2011 Mar 25.
• Fowler NR, Boustani MA, Frame A, Perkins AJ, Monahan P, Gao S, Sachs GA, Hendrie HC. Effect of patient perceptions on dementia screening in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1037-43. doi: 10.1111/j.1532-5415.2012.03991.x.

• Responsible Party: Nicole R. Fowler, PhD, Regenstrief Institute, IU Center for Aging Research Scientist, Regenstrief Institute, Inc.
• ClinicalTrials.gov Identifier: NCT01699503
• Other Study ID Numbers: R01AG040220-01A1; 1R01AG040220-01A1
• First Posted: Oct 3, 2012
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Nicole R. Fowler, PhD, Regenstrief Institute, IU Center for Aging Research Scientist, Regenstrief Institute, Inc.: Dementia; Alzheimer's Disease; Mild Cognitive Impairment; Screening
• Additional relevant MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction

Study Results

Participant Flow

Arm/Group Title	Screening Group	No Screening
Arm/Group Description	Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen (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. 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.	Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Period Title: Overall Study
STARTED	2008	1997
Baseline	1723	1693
1 Month Follow-up	998	1022
6 Month Follow-up	903	893
COMPLETED	1008	992
NOT COMPLETED	1000	1005

Baseline Characteristics

Arm/Group Title	Screening Group	No Screening	Total
Arm/Group Description	Subjects who are randomized into the screening arm of the study will be screened by the Memory Impairment Screen(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. 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.	Subjects who are randomized into the non-screening arm will receive the usual standard of care.	Total of all reporting groups
Overall Participants	1723	1693	3416
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.2 (7.0)	74.1 (6.8)	74.1 (6.9)
Sex: Female, Male (Count of Participants)
Female	1167 67.7%	1089 64.3%	2256 66%
Male	556 32.3%	604 35.7%	1160 34%
Race/Ethnicity, Customized (Count of Participants)
Black	526 30.5%	530 31.3%	1056 30.9%
White	1164 67.6%	1137 67.2%	2301 67.4%
Other	31 1.8%	24 1.4%	55 1.6%
Missing	2 0.1%	2 0.1%	4 0.1%
Co-morbidity status, no (%) (Count of Participants)
Cancer	379 22%	392 23.2%	771 22.6%
Chronic Lung Disease/Emphysema/COPD	698 40.5%	655 38.7%	1353 39.6%
Congestive Heart Failure	301 17.5%	311 18.4%	612 17.9%
Peripheral Vascular Disease	253 14.7%	257 15.2%	510 14.9%
Coronary Artery Disease	567 32.9%	585 34.6%	1152 33.7%
Diabetes	731 42.4%	685 40.5%	1416 41.5%
Hypertension	1428 82.9%	1383 81.7%	2811 82.3%
Stroke	390 22.6%	393 23.2%	783 22.9%
Charlson co-morbidity score, mean (SD) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.7 (2.8)	2.8 (3.0)	2.8 (2.9)
Education level, no (%) (Count of Participants)
Less than high school	363 21.1%	357 21.1%	720 21.1%
High school	571 33.1%	556 32.8%	1127 33%
Some college or college degree	778 45.2%	769 45.4%	1547 45.3%
Self-reported social support¥, mean (SD) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	21.0 (4.5)	20.8 (4.6)	20.9 (4.6)
Study Site, no (%) (Count of Participants)
Urban, safety net health system	725 42.1%	709 41.9%	1434 42%
Rural health system	653 37.9%	624 36.9%	1277 37.4%
Suburban and urban academic health system	345 20%	360 21.3%	705 20.6%
Health-related quality of life, mean (SD) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.67 (0.27)	0.67 (0.27)	0.67 (0.27)
Depressive symptoms, mean (SD) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.23 (4.07)	3.06 (3.69)	3.15 (3.89)
Anxiety, mean (SD) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.79 (3.33)	1.77 (3.19)	1.78 (3.26)

Outcome Measures

1. Primary Outcome

Title	Health Related Quality of Life (HRQOL)
Description	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.
Time Frame	1 month, 6 months, 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.

Arm/Group Title	Screening Group	No Screening
Arm/Group Description	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. 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.	Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Measure Participants	1723	1693
1 Month	0.71 (0.24)	0.69 (0.26)
6 Month	0.69 (0.26)	0.70 (0.25)
12 Month	0.67 (0.27)	0.68 (0.26)

2. Primary Outcome

Title	Patient Health Questionnaire (PHQ-9)
Description	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.
Time Frame	1 month, 6 months, 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.

Arm/Group Title	Screening Group	No Screening
Arm/Group Description	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. 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.	Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Measure Participants	1723	1693
1 Month	2.33 (3.22)	2.46 (3.27)
6 Month	2.50 (3.43)	2.45 (3.34)
12 Month	2.74 (3.69)	2.82 (3.71)

3. Primary Outcome

Title	Generalized Anxiety Disorder Scale (GAD-7)
Description	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.
Time Frame	1 month, 6 months, 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.

Arm/Group Title	Screening Group	No Screening
Arm/Group Description	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. 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.	Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Measure Participants	1723	1693
1 Month	1.16 (2.57)	1.24 (2.54)
6 Month	1.24 (2.60)	1.13 (2.37)
12 Month	1.31 (2.77)	1.45 (2.83)

4. Secondary Outcome

Title	Number of Participants With Health Care Utilization
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Screening Group	No Screening
Arm/Group Description	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. 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.	Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Measure Participants	1723	1693
Patients with at least 1 ED visit in 12 months	510 29.6%	512 30.2%
Patients with at least 1 hospitalization in 12 mo	336 19.5%	333 19.7%

5. Secondary Outcome

Title	Number of Participants With an Advance Directive at 12 Months
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The number analyzed for each row excludes those participants who died, withdrew, were lost to follow-up, or were excluded due to quality at each time point in the study.

Arm/Group Title	Screening Group	No Screening
Arm/Group Description	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. 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.	Subjects who are randomized into the non-screening arm will receive the usual standard of care.
Measure Participants	992	1008
Count of Participants [Participants]	653 37.9%	644 38%

Adverse Events

Time Frame	1 year
Arm/Group Title	Screening Group		No Screening
Arm/Group Description	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. 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.		Subjects who are randomized into the non-screening arm will receive the usual standard of care.
All Cause Mortality
	Screening Group		No Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/1723 (1.2%)		25/1693 (1.5%)
Serious Adverse Events
	Screening Group		No Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/1723 (3%)		47/1693 (2.8%)
Psychiatric disorders
Incident Severe Depression (	34/1723 (2%)		28/1693 (1.7%)
Incident Severe Anxiety	18/1723 (1%)		19/1693 (1.1%)
Other (Not Including Serious) Adverse Events
	Screening Group		No Screening
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1723 (0%)		0/1693 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.