Alzheimer Disease
Conditions
Brief summary
This study will measure the risks and benefits of early screening of Alzheimer's disease. Early diagnosis through screening may enhance the family member's transition to a family caregiver and reduce caregiver burden by providing an opportunity for the family member to learn about the syndrome, receive interventions, and to prepare for their new care giving role.
Detailed description
We are proposing the first randomized controlled trial (RCT) to evaluate the benefits and harms of AD screening on family members of older adults. The proposed trial will randomize 1,800 dyads (older adult and family member) into three groups. Older adults in the first group will be screened for AD at baseline coupled with disclosure of the screening results to the dyad and to the patient's primary care provider (Screening Only Group). Older adults in the second group will be screened for AD at baseline coupled with disclosure of the screening results and, if they screen positive, referred to the Aging Brain Care (ABC) Program for diagnostic evaluation and care, if AD is diagnosed (Screening Plus Group). Older adults in the third group will not be screened at baseline and will observed through surveillance of the patients' EHR for any screening or incident AD diagnoses that occurs as part of routine care. At the last follow-up assessment (24 months) we will we will screen the older adults and conduct an interview with the family caregiver to detect possible cognitive impairment (Control Group). Specific Aim 1: Evaluate the impact of AD screening on family members' quality of life. Hypothesis 1: In comparison to the control group, family members randomized to the screening only or the screening plus groups will express higher levels of health-related quality of life at 24 months as measured by the Short Form Health Survey (SF-36). Specific Aim 2: Evaluate the impact of AD screening on family members' mood and anxiety. Hypothesis 2: In comparison to the control group, family members randomized to the screening only or the screening plus groups will express lower rates of depressive and anxiety symptoms at 24 months as measured by the Patient Health Questionnaire (PHQ-9) and the Generalized Anxiety Disorder Scale (GAD-7). Specific Aim 3: Assess the impact of AD screening on family members' caregiving preparedness and caregiving self-efficacy. Hypothesis 3: In comparison to the control group, family members randomized to the screening only or the screening plus group, will be more prepared for caregiving and have higher self-efficacy at 24 months as measured by the Preparedness for Caregiving Scale and the Revised Scale for Caregiving Self-Efficacy. Specific Aim 4: Compare the effectiveness of two strategies for diagnostic evaluation and management after AD screening. Hypothesis 4: In comparison to the screening only group, family members randomized to the screening plus group will express higher levels of health-related quality of life, caregiver preparedness and caregiving self-efficacy and lower levels of depressive and anxiety symptoms at 24 months, as measured by the SF-36, Preparedness for Caregiving Scale, the Revised Scale for Caregiving Self-Efficacy, PHQ-9, and GAD-7, respectively.
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.
OTHERScreening Only
The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients * 65 years or older * At least one visit to primary care practice within past 24 months * Ability to provide informed consent * Ability to communicate in English Family Members * 21 years or older * Identified by the patient as the person most likely to provide them care if needed.\* * Lives with the patient or lives within a 50 mile radius. * Ability to provide informed consent. * Ability to communicate in English
Exclusion criteria
Patients * Has a diagnosis of AD as determined by ICD-10 code. * Evidence of a prescription for a cholinesterase inhibitors or memantine. * Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code * Permanent resident of a nursing facility * Already seen by the Healthy Aging Brain Care Program Family Member * Is a non-family member who is not a legal Healthcare Power of Attorney * Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10 code * Has a diagnosis of AD as determined by ICD-10 code.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form Health Survey (SF-36) | 24 month | The SF-36 is a general population instrument that measures health-related quality of life, mental, physical, and social functioning. It includes one multi-item scale that assesses 8 overall health concepts. These concepts are aggregated into a Physical Component Summary and a Mental Component Summary. The eight domains are combined to reach two summary scores for Physical and Mental Health which are standardized to a mean of 50, with a score above 50 representing better than average and below 50 poorer than average function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | PHQ-9 results for patient & family member at 24 months | The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27 with higher scores indicating greater depression severity. Multi-level mixed effects models will be used to examine differences in PHQ-9 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated PHQ-9 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables. |
| Anxiety Symptoms | 24 month GAD-7 scores for Family members & Patients | The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21 with higher scores indicating greater anxiety severity. Multi-level mixed effects models will be used to examine differences in GAD-7 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated GAD-7 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables. |
| Caregiving Preparedness | 24 month | The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels. Multi-level mixed effects models will be used to examine differences in Preparedness for Caregiving Scale scores for family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated Preparedness for Care |
| Caregiving Self Efficacy | 24 month result for Family member | The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable). |
Countries
United States
Participant flow
Recruitment details
Dyads recruited in primary care clinic or over the phone.
Pre-assignment details
Consented Dyads, consisting of patient and chosen family member. Randomization was completed after patient baseline to determine screening group arm.
Participants by arm
| Arm | Count |
|---|---|
| Control The patients in this group will receive no AD screening | 1,208 |
| Screening Only The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.
Screening Only: The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening | 1,202 |
| Collaborative Dementia Care Program The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,
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. | 1,206 |
| Total | 3,616 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 12 Month Outcome | Death | 9 | 6 | 6 |
| 12 Month Outcome | Missed Assessment | 62 | 59 | 58 |
| 12 Month Outcome | Withdrawal by Subject | 3 | 6 | 6 |
| 18 Month Outcome Assessment | Death | 8 | 5 | 5 |
| 18 Month Outcome Assessment | Missed Assessment | 49 | 61 | 44 |
| 18 Month Outcome Assessment | Withdrawal by Subject | 14 | 4 | 13 |
| 24 Month Outcome Assessment | Death | 13 | 13 | 3 |
| 24 Month Outcome Assessment | Missed Assessment | 17 | 21 | 38 |
| 24 Month Outcome Assessment | Withdrawal by Subject | 6 | 10 | 4 |
| 6 Month Outcome | Death | 2 | 4 | 3 |
| 6 Month Outcome | Missed Assessment | 43 | 52 | 46 |
| 6 Month Outcome | Withdrawal by Subject | 12 | 12 | 19 |
| Baseline | Withdrawal by Subject | 4 | 6 | 4 |
Baseline characteristics
| Characteristic | Control | Screening Only | Collaborative Dementia Care Program | Total |
|---|---|---|---|---|
| Age, Continuous | 63.8 in years STANDARD_DEVIATION 13 | 64.4 in years STANDARD_DEVIATION 12.7 | 64.4 in years STANDARD_DEVIATION 13.1 | 64.2 in years STANDARD_DEVIATION 12.9 |
| Oberst Caregiving Burden Scale, difficulty subscale | 15.6 units on a scale STANDARD_DEVIATION 2.8 | 15.5 units on a scale STANDARD_DEVIATION 1.8 | 15.6 units on a scale STANDARD_DEVIATION 1.8 | 15.5 units on a scale STANDARD_DEVIATION 2.1 |
| Oberst Scale, time | 21.0 units on a scale STANDARD_DEVIATION 7.3 | 21.0 units on a scale STANDARD_DEVIATION 7.2 | 20.7 units on a scale STANDARD_DEVIATION 7 | 20.9 units on a scale STANDARD_DEVIATION 7.1 |
| Race/Ethnicity, Customized Asian | 4 Participants | 9 Participants | 3 Participants | 17 Participants |
| Race/Ethnicity, Customized Black or African American | 92 Participants | 79 Participants | 71 Participants | 242 Participants |
| Race/Ethnicity, Customized Hispanic ethnicity | 3 Participants | 4 Participants | 7 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic ethnicity, self-reported | 5 Participants | 5 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 5 Participants | 5 Participants | 13 Participants |
| Race/Ethnicity, Customized White | 504 Participants | 501 Participants | 525 Participants | 1536 Participants |
| Severe Anxiety | 5 Participants | 5 Participants | 3 Participants | 14 Participants |
| Severe Depression | 10 Participants | 13 Participants | 7 Participants | 24 Participants |
| Sex: Female, Male Female | 338 Participants | 318 Participants | 411 Participants | 1224 Participants |
| Sex: Female, Male Male | 198 Participants | 194 Participants | 300 Participants | 583 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 24 / 608 | 8 / 608 | 19 / 607 | 9 / 607 | 12 / 607 | 5 / 607 |
| other Total, other adverse events | 41 / 608 | 34 / 608 | 42 / 607 | 19 / 607 | 43 / 607 | 35 / 607 |
| serious Total, serious adverse events | 79 / 608 | 101 / 608 | 69 / 607 | 82 / 607 | 85 / 607 | 96 / 607 |
Outcome results
Primary
Short Form Health Survey (SF-36)
The SF-36 is a general population instrument that measures health-related quality of life, mental, physical, and social functioning. It includes one multi-item scale that assesses 8 overall health concepts. These concepts are aggregated into a Physical Component Summary and a Mental Component Summary. The eight domains are combined to reach two summary scores for Physical and Mental Health which are standardized to a mean of 50, with a score above 50 representing better than average and below 50 poorer than average function.
Time frame: 24 month
Population: Patient \& Family Member Outcome Results of SF-36 at 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Short Form Health Survey (SF-36) | Family Member- Physical Health Component | 48.4 score on a scale | Standard Deviation 9.8 |
| Control | Short Form Health Survey (SF-36) | Patient-Physical Health Component | 44.7 score on a scale | Standard Deviation 11.1 |
| Control | Short Form Health Survey (SF-36) | Family Member- Mental Health Component | 54.5 score on a scale | Standard Deviation 7.2 |
| Control | Short Form Health Survey (SF-36) | Patient-Mental Health Component | 54.9 score on a scale | Standard Deviation 7.5 |
| Screening Only | Short Form Health Survey (SF-36) | Patient-Mental Health Component | 55.3 score on a scale | Standard Deviation 7.4 |
| Screening Only | Short Form Health Survey (SF-36) | Family Member- Mental Health Component | 55.3 score on a scale | Standard Deviation 6.7 |
| Screening Only | Short Form Health Survey (SF-36) | Family Member- Physical Health Component | 47.8 score on a scale | Standard Deviation 10.2 |
| Screening Only | Short Form Health Survey (SF-36) | Patient-Physical Health Component | 44.8 score on a scale | Standard Deviation 11.2 |
| Screen Plus | Short Form Health Survey (SF-36) | Family Member- Physical Health Component | 48.8 score on a scale | Standard Deviation 9.4 |
| Screen Plus | Short Form Health Survey (SF-36) | Patient-Physical Health Component | 44.4 score on a scale | Standard Deviation 11.1 |
| Screen Plus | Short Form Health Survey (SF-36) | Patient-Mental Health Component | 55.3 score on a scale | Standard Deviation 7.6 |
| Screen Plus | Short Form Health Survey (SF-36) | Family Member- Mental Health Component | 54.7 score on a scale | Standard Deviation 7.5 |
Secondary
Anxiety Symptoms
The investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of AD screening on caregivers and patients anxiety. The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21 with higher scores indicating greater anxiety severity. Multi-level mixed effects models will be used to examine differences in GAD-7 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated GAD-7 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables.
Time frame: 24 month GAD-7 scores for Family members & Patients
Population: 24 month GAD-7 scores for Family members \& Patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Anxiety Symptoms | Family member | 1.8 score on a scale | Standard Deviation 3 |
| Control | Anxiety Symptoms | Patient | 1.7 score on a scale | Standard Deviation 2.6 |
| Screening Only | Anxiety Symptoms | Family member | 1.6 score on a scale | Standard Deviation 2.5 |
| Screening Only | Anxiety Symptoms | Patient | 1.8 score on a scale | Standard Deviation 3.3 |
| Screen Plus | Anxiety Symptoms | Family member | 1.7 score on a scale | Standard Deviation 3 |
| Screen Plus | Anxiety Symptoms | Patient | 1.8 score on a scale | Standard Deviation 3 |
Secondary
Caregiving Preparedness
The Preparedness for Caregiving Scale consists of eight items that asks family members how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5-point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving; the lower the score, the less prepared the caregiver feels. Multi-level mixed effects models will be used to examine differences in Preparedness for Caregiving Scale scores for family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated Preparedness for Care
Time frame: 24 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Caregiving Preparedness | 3.0 score on a scale | Standard Deviation 0.7 |
| Screening Only | Caregiving Preparedness | 2.9 score on a scale | Standard Deviation 0.6 |
| Screen Plus | Caregiving Preparedness | 2.9 score on a scale | Standard Deviation 0.7 |
Secondary
Caregiving Self Efficacy
The investigators will use the Revised Scale for Caregiving Self Efficacy to measure the impact of AD screening on caregiver self-efficacy. Respondents rate their degree of self-efficacy on a scale from 0 (absolutely incapable) to 100 (fully capable).
Time frame: 24 month result for Family member
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Caregiving Self Efficacy | 79.1 score on a scale | Standard Deviation 15.5 |
| Screening Only | Caregiving Self Efficacy | 79.3 score on a scale | Standard Deviation 14 |
| Screen Plus | Caregiving Self Efficacy | 79.6 score on a scale | Standard Deviation 15 |
Secondary
Depressive Symptoms
The investigators will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of AD screening on caregivers and patients mood. The PHQ-9 is a nine-item depression scale with a total score from 0 to 27 with higher scores indicating greater depression severity. Multi-level mixed effects models will be used to examine differences in PHQ-9 scores for both patients and family members using dyadic analytic approaches. For this aim, we will compare family members in the two screening groups (Screening Only and Screening Plus) to those in the no screening (Control) group. Repeated PHQ-9 scores from both patients and family members will be included as the outcome variables with participant type (patient or family member), group (Screening Only and Screening Plus versus Control), time, and interaction between groups and time as independent variables.
Time frame: PHQ-9 results for patient & family member at 24 months
Population: PHQ-9 results for patient \& family member at 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Depressive Symptoms | Patient 24 Month | 2.8 score on a scale | Standard Deviation 3.6 |
| Control | Depressive Symptoms | Family member 24 Month | 2.4 score on a scale | Standard Deviation 3.4 |
| Screening Only | Depressive Symptoms | Family member 24 Month | 2.3 score on a scale | Standard Deviation 2.9 |
| Screening Only | Depressive Symptoms | Patient 24 Month | 2.6 score on a scale | Standard Deviation 3.8 |
| Screen Plus | Depressive Symptoms | Family member 24 Month | 2.2 score on a scale | Standard Deviation 3.2 |
| Screen Plus | Depressive Symptoms | Patient 24 Month | 2.9 score on a scale | Standard Deviation 3.9 |