Alzheimer's Disease, Dementia, Mild Cognitive Impairment
Conditions
Keywords
Dementia, Alzheimer's Disease, Mild Cognitive Impairment, Screening
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.
Interventions
BEHAVIORALCollaborative 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.
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1,723 |
| No Screening Subjects who are randomized into the non-screening arm will receive the usual standard of care. | 1,693 |
| Total | 3,416 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 31 | 40 |
| Overall Study | Excluded due to quality | 783 | 791 |
| Overall Study | Lost to Follow-up | 121 | 117 |
| Overall Study | Withdrawal by Subject | 65 | 57 |
Baseline characteristics
| Characteristic | Screening Group | Total | No Screening |
|---|---|---|---|
| Age, Continuous | 74.2 years STANDARD_DEVIATION 7 | 74.1 years STANDARD_DEVIATION 6.9 | 74.1 years STANDARD_DEVIATION 6.8 |
| Anxiety, mean (SD) | 1.79 units on a scale STANDARD_DEVIATION 3.33 | 1.78 units on a scale STANDARD_DEVIATION 3.26 | 1.77 units on a scale STANDARD_DEVIATION 3.19 |
| Charlson co-morbidity score, mean (SD) | 2.7 units on a scale STANDARD_DEVIATION 2.8 | 2.8 units on a scale STANDARD_DEVIATION 2.9 | 2.8 units on a scale STANDARD_DEVIATION 3 |
| Co-morbidity status, no (%) Cancer | 379 Participants | 771 Participants | 392 Participants |
| Co-morbidity status, no (%) Chronic Lung Disease/Emphysema/COPD | 698 Participants | 1353 Participants | 655 Participants |
| Co-morbidity status, no (%) Congestive Heart Failure | 301 Participants | 612 Participants | 311 Participants |
| Co-morbidity status, no (%) Coronary Artery Disease | 567 Participants | 1152 Participants | 585 Participants |
| Co-morbidity status, no (%) Diabetes | 731 Participants | 1416 Participants | 685 Participants |
| Co-morbidity status, no (%) Hypertension | 1428 Participants | 2811 Participants | 1383 Participants |
| Co-morbidity status, no (%) Peripheral Vascular Disease | 253 Participants | 510 Participants | 257 Participants |
| Co-morbidity status, no (%) Stroke | 390 Participants | 783 Participants | 393 Participants |
| Depressive symptoms, mean (SD) | 3.23 units on a scale STANDARD_DEVIATION 4.07 | 3.15 units on a scale STANDARD_DEVIATION 3.89 | 3.06 units on a scale STANDARD_DEVIATION 3.69 |
| Education level, no (%) High school | 571 Participants | 1127 Participants | 556 Participants |
| Education level, no (%) Less than high school | 363 Participants | 720 Participants | 357 Participants |
| Education level, no (%) Some college or college degree | 778 Participants | 1547 Participants | 769 Participants |
| Health-related quality of life, mean (SD) | 0.67 units on a scale STANDARD_DEVIATION 0.27 | 0.67 units on a scale STANDARD_DEVIATION 0.27 | 0.67 units on a scale STANDARD_DEVIATION 0.27 |
| Race/Ethnicity, Customized Black | 526 Participants | 1056 Participants | 530 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 31 Participants | 55 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 1164 Participants | 2301 Participants | 1137 Participants |
| Self-reported social support¥, mean (SD) | 21.0 units on a scale STANDARD_DEVIATION 4.5 | 20.9 units on a scale STANDARD_DEVIATION 4.6 | 20.8 units on a scale STANDARD_DEVIATION 4.6 |
| Sex: Female, Male Female | 1167 Participants | 2256 Participants | 1089 Participants |
| Sex: Female, Male Male | 556 Participants | 1160 Participants | 604 Participants |
| Study Site, no (%) Rural health system | 653 Participants | 1277 Participants | 624 Participants |
| Study Site, no (%) Suburban and urban academic health system | 345 Participants | 705 Participants | 360 Participants |
| Study Site, no (%) Urban, safety net health system | 725 Participants | 1434 Participants | 709 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 21 / 1,723 | 25 / 1,693 |
| other Total, other adverse events | 0 / 1,723 | 0 / 1,693 |
| serious Total, serious adverse events | 52 / 1,723 | 47 / 1,693 |
Outcome results
Primary
Generalized Anxiety Disorder Scale (GAD-7)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Screening Group | Generalized Anxiety Disorder Scale (GAD-7) | 1 Month | 1.16 units on a scale | Standard Deviation 2.57 |
| Screening Group | Generalized Anxiety Disorder Scale (GAD-7) | 6 Month | 1.24 units on a scale | Standard Deviation 2.6 |
| Screening Group | Generalized Anxiety Disorder Scale (GAD-7) | 12 Month | 1.31 units on a scale | Standard Deviation 2.77 |
| No Screening | Generalized Anxiety Disorder Scale (GAD-7) | 1 Month | 1.24 units on a scale | Standard Deviation 2.54 |
| No Screening | Generalized Anxiety Disorder Scale (GAD-7) | 6 Month | 1.13 units on a scale | Standard Deviation 2.37 |
| No Screening | Generalized Anxiety Disorder Scale (GAD-7) | 12 Month | 1.45 units on a scale | Standard Deviation 2.83 |
Primary
Health Related Quality of Life (HRQOL)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Screening Group | Health Related Quality of Life (HRQOL) | 1 Month | 0.71 units on a scale | Standard Deviation 0.24 |
| Screening Group | Health Related Quality of Life (HRQOL) | 6 Month | 0.69 units on a scale | Standard Deviation 0.26 |
| Screening Group | Health Related Quality of Life (HRQOL) | 12 Month | 0.67 units on a scale | Standard Deviation 0.27 |
| No Screening | Health Related Quality of Life (HRQOL) | 1 Month | 0.69 units on a scale | Standard Deviation 0.26 |
| No Screening | Health Related Quality of Life (HRQOL) | 6 Month | 0.70 units on a scale | Standard Deviation 0.25 |
| No Screening | Health Related Quality of Life (HRQOL) | 12 Month | 0.68 units on a scale | Standard Deviation 0.26 |
Primary
Patient Health Questionnaire (PHQ-9)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Screening Group | Patient Health Questionnaire (PHQ-9) | 12 Month | 2.74 units on a scale | Standard Deviation 3.69 |
| Screening Group | Patient Health Questionnaire (PHQ-9) | 1 Month | 2.33 units on a scale | Standard Deviation 3.22 |
| Screening Group | Patient Health Questionnaire (PHQ-9) | 6 Month | 2.50 units on a scale | Standard Deviation 3.43 |
| No Screening | Patient Health Questionnaire (PHQ-9) | 12 Month | 2.82 units on a scale | Standard Deviation 3.71 |
| No Screening | Patient Health Questionnaire (PHQ-9) | 1 Month | 2.46 units on a scale | Standard Deviation 3.27 |
| No Screening | Patient Health Questionnaire (PHQ-9) | 6 Month | 2.45 units on a scale | Standard Deviation 3.34 |
Secondary
Number of Participants With an Advance Directive at 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.
Time frame: 12 months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening Group | Number of Participants With an Advance Directive at 12 Months | 653 Participants |
| No Screening | Number of Participants With an Advance Directive at 12 Months | 644 Participants |
Secondary
Number of Participants With Health Care Utilization
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Screening Group | Number of Participants With Health Care Utilization | Patients with at least 1 ED visit in 12 months | 510 Participants |
| Screening Group | Number of Participants With Health Care Utilization | Patients with at least 1 hospitalization in 12 mo | 336 Participants |
| No Screening | Number of Participants With Health Care Utilization | Patients with at least 1 ED visit in 12 months | 512 Participants |
| No Screening | Number of Participants With Health Care Utilization | Patients with at least 1 hospitalization in 12 mo | 333 Participants |