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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR014434 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The prevalence of family caregivers is projected to increase in concert with the projected increase in number of AD patients. The focus of the study is to gather systematic data on the acceptability and efficacy of a unique technology-based, culturally- tailored psycho-social intervention program that targets ethnically/culturally diverse family caregivers of patients with Alzheimer's Disease. The overall goal of the project is to improve the lives of family caregivers as well as their ability to provide care to their loved one and to reduce disparities in access to needed services and support among caregiver populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregiving Condition | Experimental | Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics |
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| Nutrition Condition | Placebo Comparator | Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiving condition | Behavioral | The intervention will consist of multimedia features accessible via the study-provided tablet. The components include: skill-building sessions and modules; a resource guide; an annotated reading list; information and tips; expert educational seminars (video); and structured support group sessions (6 sessions). All the sessions (home-based, one-on-one, and support group sessions) will last about 60-90 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms. | Baseline, 6-mth follow-up and 12-mth follow-up |
| Caregiving Burden 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 |
| Caregiver's Self Report of Self-care | A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself. | Baseline, 6-mth follow-up and 12-mth follow-up |
| Caregiver's Self-report of Physical Health | SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health. | Baseline, 6-mth follow-up and 12-mth follow-up |
| Caregiver's Self-efficacy | A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy. | Baseline, 6-mth follow-up and 12-mth follow-up |
| Positive Aspects of Caregiving | An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Loewenstein, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregiving Condition | Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics Caregiving condition |
| FG001 | Nutrition Condition | Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition Nutrition condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregiving Condition | Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics Caregiving condition |
| BG001 | Nutrition Condition |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Depression as Measured by Center for Epidemiologic Studies Depression Scale (CES-D) | CES-D Scale ranges from 0 to 30 with higher scores indicating greater frequency of depressive symptoms. | Follow up visits were not completed for all participants | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
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Per protocol, adverse events will not be collected during the course of this study.
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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 | Caregiving Condition | Participants will receive a computer tablet and have access to web-based skill building sessions, videos from experts, annotated resources and information and tips on caregiving-related topics Caregiving condition |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Loewenstein | University of Miami | 305-355-7016 | dloewenstein@miami.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 30, 2018 | Apr 23, 2019 | Prot_SAP_000.pdf |
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| Nutrition condition | Behavioral | The intervention will provide resource and information tips on topics related to Nutrition for a total of 8 sessions. The first and last session will be home-based and all the other sessions will be conducted via web-conferencing using the tablet provided. |
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| Baseline, 6-mth follow-up and 12-mth follow-up |
Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition Nutrition condition |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Caregiving Burden as Measured by Burden Inventory | Higher score means greater level of caregiver burden. Range (0-44) | Follow up visits were not completed for all participants | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
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| Primary | Caregiver's Self Report of Self-care | A 13 Item self care questionnaire is used to measure caregivers self care. Each item can be scored as 0,1,negative 3 or negative 4. The total score ranging from negative 52 to 13. Higher score means better in keeping medical obligations to him/herself. | Follow up visits were not completed for all participants | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
|
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| Primary | Caregiver's Self-report of Physical Health | SF 12 Health Survey was used to measure physical health of the caregiver. Scores ranges from 0 to 35 with lower score means less limitation to physical health. | Follow up visits were not completed for all participants | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
|
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| Primary | Caregiver's Self-efficacy | A 15 item Caregiver's self efficacy questionnaire will be used to assess caregiver's self-efficacy. The questionnaire score ranges from 0-1500 percent with a lower percentage score indicating less efficacy. | Follow up visits were not completed for all participants | Posted | Mean | Standard Deviation | percentage of efficacy | Baseline, 6-mth follow-up and 12-mth follow-up |
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| Primary | Positive Aspects of Caregiving | An 11 item positive aspects of caregiving questionnaire was used to measure positive aspects of caregiving. Each item can be scored 0, 1, 2, 3, 4, negative 3 or negative 4. The total score ranging from negative 44 to 44. Higher score means more positive feelings towards caregiving. | Follow up visits were not completed for all participants | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6-mth follow-up and 12-mth follow-up |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Nutrition Condition | Participants will receive a computer tablet and have access to web-based training sessions on different topics related to nutrition Nutrition condition | 0 | 0 | 0 | 0 | 0 | 0 |
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| 6 month follow up |
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| 12 month follow up |
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| 6 month follow up |
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| 12 month follow up |
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| 6 month follow up |
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| 12 month follow up |
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| 6 month follow up |
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| 12 month follow up |
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| 6 month follow up |
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| 12 month follow up |
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