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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG056325-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The patients in this group will receive no AD screening | |
| Screening Only | Active Comparator | 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. |
|
| Collaborative Dementia Care Program | Experimental | 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, |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative Dementia Care Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Patients
Family Members
Exclusion Criteria:
Patients
Family Member
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Fowler, PHD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States | ||
| IU Health-Primary Care Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42008257 | Derived | Fowler NR, Perkins AJ, Gao S, Bakas T, Head KJ, Higbie A, Baucco C, Callahan CM, Williams-Farrelly MM, Boustani MA. Benefits and Harms of Dementia Screening for Family Members of Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 1;186(6):689-700. doi: 10.1001/jamainternmed.2026.0844. | |
| 32075686 | Derived | Fowler NR, Head KJ, Perkins AJ, Gao S, Callahan CM, Bakas T, Suarez SD, Boustani MA. Examining the benefits and harms of Alzheimer's disease screening for family members of older adults: study protocol for a randomized controlled trial. Trials. 2020 Feb 19;21(1):202. doi: 10.1186/s13063-019-4029-5. |
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Consented Dyads, consisting of patient and chosen family member. Randomization was completed after patient baseline to determine screening group arm.
Dyads recruited in primary care clinic or over the phone.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The patients in this group will receive no AD screening |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| 6 Month Outcome |
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| 12 Month Outcome |
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| 18 Month Outcome Assessment |
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| 24 Month Outcome Assessment |
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Baseline Demographic and Clinical Characteristics of Randomized Dyads, total unique participants aggregated by Patients and Family within each arm. Excluding Dyads who withdrew at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The patients in this group will receive no AD screening |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient characteristic: Patient Age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patient & Family Member Outcome Results of SF-36 at 24 months | Posted | Mean | Standard Deviation | score on a scale | 24 month |
|
Patient death and hospitalization were collected from EMR quarterly and during participant contact at each study milestone from baseline through 24 month assessment. Family member death and hospitalization were collected during participant contact at study milestones post-baseline at the 6month through 24 month assessment. Patient and Family member risk of severe depression based on post-baseline PHQ-9 and risk of severe anxiety based on post baseline GAD-7 score.
All Cause mortality is the total unique participants all-cause mortality, i.e.. patient and family member mortality combined.
Serious adverse event include Inpatient Hospitalization or prolongation of existing hospitalization, including patients for all milestones and family member data post-baseline.
Study risk of severe depression and anxiety were assessed for all patients and family members post-baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Patients | The patients in this group will receive no AD screening | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization or prolongation of existing hospitalization | General disorders | Systematic Assessment | Inpatient Hospitalization of patients and family members either self-reported or discovered through EMR. None were determined protocol related. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Depression Post- Baseline as measured by PHQ-9 (≥15) | Psychiatric disorders | Systematic Assessment | Severe Depression post-baseline as determined by clinical cut point of score (≥15). Participants were offered resources by PI and no instances were determined as study related. |
The study staff completed recruitment despite adjustments from Covid-19. Yet, because of the long follow up period, 24-month assessments, we will requested a no cost extension to complete all outcome data collection and analysis. The official award end date was February 28, 2023 and a 12-month NCE extended the project to February 28, 2024, allowing time for data quality check, data analysis and study closeout.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole R. Fowler, PhD, MHSA; Associate Professor of Medicine | Indiana University School of Medicine; Indiana University Center for Aging Research; Regenstrief Institute, Inc. | 317-274-9021 | fowlern@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2022 | Sep 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Screening Only | Other | 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 |
|
| PHQ-9 results for patient & family member at 24 months |
| 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. | 24 month GAD-7 scores for Family members & Patients |
| 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 | 24 month |
| 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). | 24 month result for Family member |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
Due to intent to treat protocol a dyad will continue on in the study even if one or both miss an assessment. A death or withdrawal would remove both patient and family member of the dyad from continuing participation. |
|
| NOT COMPLETED |
|
|
Due to intent to treat protocol a dyad will continue on in the study even if one or both miss an assessment. A death or withdrawal would remove both patient and family member of the dyad from continuing participation. |
|
| NOT COMPLETED |
|
|
Due to intent to treat protocol a dyad will continue on in the study even if one or both miss an assessment. A death or withdrawal would remove both patient and family member of the dyad from continuing participation. |
|
| NOT COMPLETED |
|
|
Due to intent to treat protocol a dyad will continue on in the study even if one or both miss an assessment. A death or withdrawal would remove both patient and family member of the dyad from continuing participation. |
|
| NOT COMPLETED |
|
|
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
Patient Age,
| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Family Member Characteristic - Family Member Age | Family Member Age | Mean | Standard Deviation | in years |
|
| Sex: Female, Male | Patient characteristic- Patient Sex | Patient Sex | Count of Participants | Participants |
|
| Sex: Female, Male | Family Member Characteristic - Family Member Sex | Family Member Sex- excluding refused/withdrawn | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Patient characteristic- Patient Race/Ethnicity | Patient Race/Ethnicity | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Family Member Characteristic -Race/Ethnicity | Family Member Race/Ethnicity-excluding missing/withdrawn | Count of Participants | Participants |
|
| Severe Depression | Baseline Patient Characteristic- Severe Depression is defined as PHQ-9 score of ≥15 | Patient Depressive Symptoms, PHQ-9- The PHQ-9 is a nine-item depression scale with a total score from 0 to 27 with higher scores indicating greater depression severity. | Count of Participants | Participants |
|
| Severe Anxiety | Baseline patient characteristic-Severe Anxiety is defined as GAD-7 score of ≥15 | Patient Severe Anxiety is defined as GAD-7 score of ≥15 The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21 with higher scores indicating greater anxiety severity. | Count of Participants | Participants |
|
| Severe Depression | Baseline Family Characteristic -Severe Depression is defined as PHQ-9 score of ≥15 The PHQ-9 is a nine-item depression scale with a total score from 0 to 27 with higher scores indicating greater depression severity. | Family member -Severe Depression is defined as PHQ-9 score of ≥15- excluding missing/withdrawn | Count of Participants | Participants |
|
| Severe Anxiety | Baseline Family Characteristic - Severe Anxiety is defined as GAD-7 score of ≥15 The GAD-7 is a seven-item anxiety scale with a total score from 0 to 21 with higher scores indicating greater anxiety severity. | Family Member - Severe Anxiety is defined as GAD-7 score of ≥15- excluding missing/withdrawn | Count of Participants | Participants |
|
| Oberst Scale, time | The Oberst Time and Difficulty subscales are two parts of the Oberst Caregiving Burden Scale (OCBS), which measures the perceived time spent and difficulty associated with performing caregiving tasks. Each item is scored on a 5-point response scale. In response to time for each item, the caregiver chooses an amount ranging from no time (score, 1) to a great deal of time (score, 5) spent on tasks related to caregiving. Scores were calculated by averaging across the 15 items of the time and difficulty subscales, thus achieving an average score between 1 and 5 for each subscale. | Family member- Oberst Scale, time- excluding missing/withdrawn | Mean | Standard Deviation | units on a scale |
|
| Oberst Caregiving Burden Scale, difficulty subscale | The Oberst Time and Difficulty subscales are two parts of the Oberst Caregiving Burden Scale (OCBS), which measures the perceived time spent and difficulty associated with performing caregiving tasks. Each item is scored on a 5-point response scale. In response to difficulty for each item, the caregiver chooses an amount ranging from not difficult (score, 1) to extremely difficult (score, 5). Scores were calculated by averaging across the 15 items of the time and difficulty subscales, thus achieving an average score between 1 and 5 for each subscale. | Family member- Oberst Scale, difficulty- excluding missing/withdrawn | Mean | Standard Deviation | units on a scale |
|
| Screening Only |
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. |
| OG002 | Screen Plus | Collaborative 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, |
|
|
| 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. | PHQ-9 results for patient & family member at 24 months | Posted | Mean | Standard Deviation | score on a scale | PHQ-9 results for patient & family member at 24 months |
|
|
|
| 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. | 24 month GAD-7 scores for Family members & Patients | Posted | Mean | Standard Deviation | score on a scale | 24 month GAD-7 scores for Family members & Patients |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | 24 month |
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 24 month result for Family member |
|
|
|
| 608 |
| 79 |
| 608 |
| 41 |
| 608 |
| EG001 | Control Family Member | Represents the Family member of the Control Group patient. The patients in this group will receive no AD screening | 8 | 608 | 101 | 608 | 34 | 608 |
| EG002 | Screening Only Patient | 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. | 19 | 607 | 69 | 607 | 42 | 607 |
| EG003 | Screening Only Family Member. | Represents the Family member of the Screening only group. 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. | 9 | 607 | 82 | 607 | 19 | 607 |
| EG004 | Collaborative Dementia Care Program Patients | 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, | 12 | 607 | 85 | 607 | 43 | 607 |
| EG005 | Collaborative Dementia Care Program Family Member | Represents the Family member of the 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, | 5 | 607 | 96 | 607 | 35 | 607 |
|
|
| Severe Anxiety Post-Baseline as measured by GAD-7 (≥15) | Psychiatric disorders | Systematic Assessment | Severe Anxiety post-baseline as determined by clinical cut point of score (≥15). Participants were offered resources by PI and no instances were determined as study related. |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Male |
|
| Male |
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| Title | Measurements |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Family member 24 Month |
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| Patient |
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