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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01AG054009 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The proposed study will develop and test the efficacy and feasibility of a dyadic-based intervention program (DT), delivered through state-of-the art computer tablet technology. A novel feature of the investigation is its focus on both the caregiver and the recipient of care (person with AD) and the integration of an evidenced-based caregiver intervention and evidenced-based cognitive/functional training for the care recipient. The program will be tailored for the caregiver and emphasize issues important to caregivers, not only in the earlier stages of caregiving, but will also target issues across the caregiving trajectory to help prepare the caregiver for changes in their role. Two hundred and forty Hispanic, African American and White/Caucasian dyads will be randomized to the DT intervention or Control condition. Measures at baseline and the 6 and 12-month follow-ups will include indices of care recipient processing speed and quality of life, and caregiver outcomes such as; depression, burden, self-care activities and social support . Information will also be gathered on ethnic differences in response to the intervention and estimates of cost effectiveness of the intervention.
We will recruit and randomly assign, following a baseline assessment, 246 dyads will be enrolled and randomly assigned to one of two groups: 1) Caregiving Condition or 2) Health Promotion (Nutrition) Condition. The entire study is home-based. The intervention will be delivered over 6 months using computer tablet technology in Spanish or English. Assessments will occur in the beginning of the study, 6 months, and 12 months (after completion of the intervention)
Interested participants (caregivers) can contact us via telephone or email after seeing a flyer posted in various WCM/NYP locations including the Irving Sherwood Wright Center on Aging. One of our research associates (RA) will provide more information about the study to potential participants. The trained RA will use a telephone script with consent language to obtain permission to ask them questions to determine their eligibility through a phone screen script. If the participant is ineligible for the study, all screening data will be deleted. If the caregiver participant is eligible for the study, an appointment will be provided, and one of our RAs will visit the participants (caregiver and care recipient) and conduct the baseline assessment at the participants' home in their preferred language (Spanish or English). This assessment with the caregiver will last between 2 and 3 hours, additionally the assessment with the care recipient will last approximately 1.5 hours. We will use Qualtrics (online survey/data collection service) to administer the assessments.
The baseline assessment with the caregiver (CG) consists of a series of questionnaires assessing the level of burden, and depression perceived by the CG while providing the care, the amount of social support available to the CG, and the self-care activities of the CG to provide continuing care to their loved ones. The assessment with the care recipient consists of measures of processing speed (digit symbol). In addition, the care recipient will complete a computer-based questionnaire assessing their quality of life. The assessment with the caregiver and care recipient might not be completed in the same home visit. The study protocol allows multiple visits to complete the assessments.
During the baseline home visit, the RA will go over the written informed consent and HIPAA authorization with the participants (caregiver and care recipient). The assessment will not begin unless the participant has a full understanding of the informed consent form and has signed the form. The care recipient will additionally be given a Consent Feedback Tool, as an added step to make sure they understand the consent form since they have mild cognitive impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Condition | Experimental | Exposing caregivers to caregiving-related information and care recipients to cognitive training tasks |
|
| Control Condition | Placebo Comparator | Exposing caregivers to Nutrition and Health promotional material. The care recipients are exposed to plain words games from computer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Condition | Behavioral | Caregivers will access caregiving related information. Care Recipients will access cognitive training program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Score for Caregiver as Measured by CES-D | Higher score on the Center for Epidemiological Studies Depression scale (CES-D) means greater frequency of depressive symptoms. Range (0-30) | Baseline, 6-mth follow-up and 12-mth follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory | Higher score means greater level of caregiver burden. Range (0-44) | Baseline, 6-mth follow-up and 12-mth follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Caregiver's Self Report of Self-care | Higher score means better in keeping medical obligations to him/herself. Range (0-12) | Baseline, 6-mth follow-up and 12-mth follow-up |
| Change in Caregiver's Social Support |
CAREGIVER (CG)
Inclusion Criteria:
Exclusion Criteria:
CARE RECIPIENT (CR)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara J. Czaja, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States | ||
| Weill Cornell Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Care Recipients - Intervention Condition | Exposing care recipients to cognitive training tasks. |
| FG001 | Care Recipients - Control | Exposing care recipients to plain words games from computer. |
| FG002 | Caregivers - Intervention Condition | Exposing caregivers to caregiving-related information. |
| FG003 | Caregivers - Control | Exposing caregivers to Nutrition and Health promotional material. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Care Recipients - Intervention Condition | Exposing care recipients to cognitive training tasks |
| BG001 | Care Recipients - Control Condition | Exposing care recipients to plain words games from computer. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Depression Score for Caregiver as Measured by CES-D | Higher score on the Center for Epidemiological Studies Depression scale (CES-D) means greater frequency of depressive symptoms. Range (0-30) | This measure was only administered to caregivers. Missing data is due to participants either lost to follow up or withdrew between the baseline assessment and 12 month assessment. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
Five years
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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 | Care Recipients - Intervention Condition | Exposing care recipients to cognitive training tasks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-reported depression | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara J. Czaja | Weill Medical College of Cornell University | 646-962-7141 | sjc7004@med.cornell.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 | Dec 10, 2020 | Feb 1, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2022 | Jan 31, 2023 | ICF_000.pdf |
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| Control Condition | Behavioral | Caregivers will access Nutrition and Health Promotion material. Care Recipients will access words and card games |
|
Higher score means more social support for the caregiver. Range (0-40)
| Baseline, 6-mth follow-up and 12-mth follow-up |
| Change in Care Recipient's Qualify of Life | Higher score means better quality of life as Alzheimer's patient. Range (0-52) | Baseline, 6-mth follow-up, and 12-mth follow-up |
| Change in Care Recipient's Processing Speed Using Digit Symbol Test | Higher score means faster processing speed. Range (0-100) | Baseline, 6-mth follow-up, and 12-mth follow-up |
| New York |
| New York |
| 10065 |
| United States |
| Death |
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| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Caregivers - Intervention Condition | Exposing caregivers to caregiving-related information. |
| BG003 | Caregivers - Control Condition | Exposing caregivers to Nutrition and Health promotional material. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Change in depression score for caregiver as measured by CES-D | CES-D is Center for Epidemiological Studies Depression scale, (range 0-30) higher score indicates greater depression | The primary outcome listed in the submission is caregiver specific. | Median | Inter-Quartile Range | units on a scale |
|
Exposing care recipients to plain words games from computer.
| OG002 | Caregivers - Intervention Condition | Exposing caregivers to caregiving-related information. |
| OG003 | Caregivers - Control Condition | Exposing caregivers to Nutrition and Health promotional material. |
|
|
| Secondary | Change in Caregiving Burden Score for Caregiver as Measured by Burden Inventory | Higher score means greater level of caregiver burden. Range (0-44) | This measure was only administered to caregivers. Additionally, missing data is due to some participants either being lost to follow up or withdrew between the baseline assessment and 12 month assessment. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
|
|
| Other Pre-specified | Change in Caregiver's Self Report of Self-care | Higher score means better in keeping medical obligations to him/herself. Range (0-12) | This measure was only administered to caregivers. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
|
|
| Other Pre-specified | Change in Caregiver's Social Support | Higher score means more social support for the caregiver. Range (0-40) | This measure was only administered to caregivers. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
|
|
| Other Pre-specified | Change in Care Recipient's Qualify of Life | Higher score means better quality of life as Alzheimer's patient. Range (0-52) | This measure was only administered to care recipients. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6-mth follow-up, and 12-mth follow-up |
|
|
|
| Other Pre-specified | Change in Care Recipient's Processing Speed Using Digit Symbol Test | Higher score means faster processing speed. Range (0-100) | This measure was only administered to care recipients. Additionally, missing data is due to some participants being either lost to follow up or withdrew between the baseline assessment and 12 month assessment. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6-mth follow-up, and 12-mth follow-up |
|
|
|
| 1 |
| 89 |
| 11 |
| 89 |
| 7 |
| 89 |
| EG001 | Care Recipients - Control | The care recipients are exposed to plain words games from computer. | 3 | 87 | 12 | 87 | 18 | 87 |
| EG002 | Caregivers - Intervention Condition | Exposing caregivers to caregiving-related information. | 0 | 89 | 2 | 89 | 26 | 89 |
| EG003 | Caregivers - Control | Exposing caregivers to Nutrition and Health promotional material. | 0 | 87 | 5 | 87 | 16 | 87 |
| Hospitalized | General disorders | Non-systematic Assessment |
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| Driving Impairment | General disorders | Non-systematic Assessment |
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| Access to Dangerous Object | General disorders | Non-systematic Assessment |
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| Hip Replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Institutionalized | General disorders | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Medical problem | General disorders | Non-systematic Assessment |
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| Disease progression | General disorders | Non-systematic Assessment |
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| Accidental Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Allergic reaction | General disorders | Non-systematic Assessment |
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| Broken back | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Health problems | General disorders | Non-systematic Assessment |
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| Forehead injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Heart condition | Cardiac disorders | Non-systematic Assessment |
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| Heart surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Macular Degeneration | Eye disorders | Non-systematic Assessment |
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| Hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Knee surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Leg fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| Between 18 and 65 years |
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| >=65 years |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
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| 6 month |
|
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| 12 month |
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| 6 month |
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| 12 month |
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| 6 month |
|
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| 12 month |
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| 6 month |
|
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| 12 month |
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| 6 months |
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| 12 months |
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