Trial Outcomes & Findings for Indiana University Dementia Screening Trial (NCT NCT01699503)
NCT ID: NCT01699503
Last Updated: 2019-01-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4005 participants
Primary outcome timeframe
1 month, 6 months, 12 months
Results posted on
2019-01-23
Participant Flow
Participant milestones
| Measure |
Screening Group
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.
|
No Screening
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
2008
|
1997
|
|
Overall Study
Baseline
|
1723
|
1693
|
|
Overall Study
1 Month Follow-up
|
998
|
1022
|
|
Overall Study
6 Month Follow-up
|
903
|
893
|
|
Overall Study
COMPLETED
|
1008
|
992
|
|
Overall Study
NOT COMPLETED
|
1000
|
1005
|
Reasons for withdrawal
| Measure |
Screening Group
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.
|
No Screening
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Overall Study
Death
|
31
|
40
|
|
Overall Study
Withdrawal by Subject
|
65
|
57
|
|
Overall Study
Lost to Follow-up
|
121
|
117
|
|
Overall Study
Excluded due to quality
|
783
|
791
|
Baseline Characteristics
22 participants refused to answer their education level
Baseline characteristics by cohort
| Measure |
Screening Group
n=1723 Participants
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.
|
No Screening
n=1693 Participants
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
Total
n=3416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.2 years
STANDARD_DEVIATION 7.0 • n=1723 Participants
|
74.1 years
STANDARD_DEVIATION 6.8 • n=1693 Participants
|
74.1 years
STANDARD_DEVIATION 6.9 • n=3416 Participants
|
|
Sex: Female, Male
Female
|
1167 Participants
n=1723 Participants
|
1089 Participants
n=1693 Participants
|
2256 Participants
n=3416 Participants
|
|
Sex: Female, Male
Male
|
556 Participants
n=1723 Participants
|
604 Participants
n=1693 Participants
|
1160 Participants
n=3416 Participants
|
|
Race/Ethnicity, Customized
Black
|
526 Participants
n=1723 Participants
|
530 Participants
n=1693 Participants
|
1056 Participants
n=3416 Participants
|
|
Race/Ethnicity, Customized
White
|
1164 Participants
n=1723 Participants
|
1137 Participants
n=1693 Participants
|
2301 Participants
n=3416 Participants
|
|
Race/Ethnicity, Customized
Other
|
31 Participants
n=1723 Participants
|
24 Participants
n=1693 Participants
|
55 Participants
n=3416 Participants
|
|
Race/Ethnicity, Customized
Missing
|
2 Participants
n=1723 Participants
|
2 Participants
n=1693 Participants
|
4 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Cancer
|
379 Participants
n=1723 Participants
|
392 Participants
n=1693 Participants
|
771 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Chronic Lung Disease/Emphysema/COPD
|
698 Participants
n=1723 Participants
|
655 Participants
n=1693 Participants
|
1353 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Congestive Heart Failure
|
301 Participants
n=1723 Participants
|
311 Participants
n=1693 Participants
|
612 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Peripheral Vascular Disease
|
253 Participants
n=1723 Participants
|
257 Participants
n=1693 Participants
|
510 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Coronary Artery Disease
|
567 Participants
n=1723 Participants
|
585 Participants
n=1693 Participants
|
1152 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Diabetes
|
731 Participants
n=1723 Participants
|
685 Participants
n=1693 Participants
|
1416 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Hypertension
|
1428 Participants
n=1723 Participants
|
1383 Participants
n=1693 Participants
|
2811 Participants
n=3416 Participants
|
|
Co-morbidity status, no (%)
Stroke
|
390 Participants
n=1723 Participants
|
393 Participants
n=1693 Participants
|
783 Participants
n=3416 Participants
|
|
Charlson co-morbidity score, mean (SD)
|
2.7 units on a scale
STANDARD_DEVIATION 2.8 • n=1723 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 3.0 • n=1693 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 2.9 • n=3416 Participants
|
|
Education level, no (%)
Less than high school
|
363 Participants
n=1712 Participants • 22 participants refused to answer their education level
|
357 Participants
n=1682 Participants • 22 participants refused to answer their education level
|
720 Participants
n=3394 Participants • 22 participants refused to answer their education level
|
|
Education level, no (%)
High school
|
571 Participants
n=1712 Participants • 22 participants refused to answer their education level
|
556 Participants
n=1682 Participants • 22 participants refused to answer their education level
|
1127 Participants
n=3394 Participants • 22 participants refused to answer their education level
|
|
Education level, no (%)
Some college or college degree
|
778 Participants
n=1712 Participants • 22 participants refused to answer their education level
|
769 Participants
n=1682 Participants • 22 participants refused to answer their education level
|
1547 Participants
n=3394 Participants • 22 participants refused to answer their education level
|
|
Self-reported social support¥, mean (SD)
|
21.0 units on a scale
STANDARD_DEVIATION 4.5 • n=1723 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 4.6 • n=1693 Participants
|
20.9 units on a scale
STANDARD_DEVIATION 4.6 • n=3416 Participants
|
|
Study Site, no (%)
Urban, safety net health system
|
725 Participants
n=1723 Participants
|
709 Participants
n=1693 Participants
|
1434 Participants
n=3416 Participants
|
|
Study Site, no (%)
Rural health system
|
653 Participants
n=1723 Participants
|
624 Participants
n=1693 Participants
|
1277 Participants
n=3416 Participants
|
|
Study Site, no (%)
Suburban and urban academic health system
|
345 Participants
n=1723 Participants
|
360 Participants
n=1693 Participants
|
705 Participants
n=3416 Participants
|
|
Health-related quality of life, mean (SD)
|
0.67 units on a scale
STANDARD_DEVIATION 0.27 • n=1723 Participants
|
0.67 units on a scale
STANDARD_DEVIATION 0.27 • n=1693 Participants
|
0.67 units on a scale
STANDARD_DEVIATION 0.27 • n=3416 Participants
|
|
Depressive symptoms, mean (SD)
|
3.23 units on a scale
STANDARD_DEVIATION 4.07 • n=1723 Participants
|
3.06 units on a scale
STANDARD_DEVIATION 3.69 • n=1693 Participants
|
3.15 units on a scale
STANDARD_DEVIATION 3.89 • n=3416 Participants
|
|
Anxiety, mean (SD)
|
1.79 units on a scale
STANDARD_DEVIATION 3.33 • n=1723 Participants
|
1.77 units on a scale
STANDARD_DEVIATION 3.19 • n=1693 Participants
|
1.78 units on a scale
STANDARD_DEVIATION 3.26 • n=3416 Participants
|
PRIMARY outcome
Timeframe: 1 month, 6 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Screening Group
n=1723 Participants
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.
|
No Screening
n=1693 Participants
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Health Related Quality of Life (HRQOL)
12 Month
|
0.67 units on a scale
Standard Deviation 0.27
|
0.68 units on a scale
Standard Deviation 0.26
|
|
Health Related Quality of Life (HRQOL)
1 Month
|
0.71 units on a scale
Standard Deviation 0.24
|
0.69 units on a scale
Standard Deviation 0.26
|
|
Health Related Quality of Life (HRQOL)
6 Month
|
0.69 units on a scale
Standard Deviation 0.26
|
0.70 units on a scale
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: 1 month, 6 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Screening Group
n=1723 Participants
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.
|
No Screening
n=1693 Participants
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9)
1 Month
|
2.33 units on a scale
Standard Deviation 3.22
|
2.46 units on a scale
Standard Deviation 3.27
|
|
Patient Health Questionnaire (PHQ-9)
6 Month
|
2.50 units on a scale
Standard Deviation 3.43
|
2.45 units on a scale
Standard Deviation 3.34
|
|
Patient Health Questionnaire (PHQ-9)
12 Month
|
2.74 units on a scale
Standard Deviation 3.69
|
2.82 units on a scale
Standard Deviation 3.71
|
PRIMARY outcome
Timeframe: 1 month, 6 months, 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Screening Group
n=1723 Participants
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.
|
No Screening
n=1693 Participants
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Generalized Anxiety Disorder Scale (GAD-7)
1 Month
|
1.16 units on a scale
Standard Deviation 2.57
|
1.24 units on a scale
Standard Deviation 2.54
|
|
Generalized Anxiety Disorder Scale (GAD-7)
6 Month
|
1.24 units on a scale
Standard Deviation 2.60
|
1.13 units on a scale
Standard Deviation 2.37
|
|
Generalized Anxiety Disorder Scale (GAD-7)
12 Month
|
1.31 units on a scale
Standard Deviation 2.77
|
1.45 units on a scale
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
Screening Group
n=1723 Participants
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.
|
No Screening
n=1693 Participants
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Number of Participants With Health Care Utilization
Patients with at least 1 ED visit in 12 months
|
510 Participants
|
512 Participants
|
|
Number of Participants With Health Care Utilization
Patients with at least 1 hospitalization in 12 mo
|
336 Participants
|
333 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Screening Group
n=992 Participants
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.
|
No Screening
n=1008 Participants
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Number of Participants With an Advance Directive at 12 Months
|
653 Participants
|
644 Participants
|
Adverse Events
Screening Group
Serious events: 52 serious events
Other events: 0 other events
Deaths: 21 deaths
No Screening
Serious events: 47 serious events
Other events: 0 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Screening Group
n=1723 participants at risk
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.
|
No Screening
n=1693 participants at risk
Subjects who are randomized into the non-screening arm will receive the usual standard of care.
|
|---|---|---|
|
Psychiatric disorders
Incident Severe Depression (
|
2.0%
34/1723 • 1 year
|
1.7%
28/1693 • 1 year
|
|
Psychiatric disorders
Incident Severe Anxiety
|
1.0%
18/1723 • 1 year
|
1.1%
19/1693 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place