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This is a cluster randomized controlled trial to determine the feasibility and preliminary effectiveness of culturally adapted psychosocial intervention for Alzheimer's family caregivers in Vietnam. The psychosocial intervention is being compared with an enhance control condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH-VN | Experimental | In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months |
|
| Enhanced control | No Intervention | Single session with education about nature of dementia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH-VIETNAM | Behavioral | Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Inventory-4 | Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-4 | Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity). | 3 months |
| Alzheimer's Disease Knowledge Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ladson Hinton, MD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Geriatric Hospital | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30334942 | Derived | Nguyen TA, Nguyen H, Pham T, Nguyen TH, Hinton L. A cluster randomized controlled trial to test the feasibility and preliminary effectiveness of a family dementia caregiver intervention in Vietnam: The REACH VN study protocol. Medicine (Baltimore). 2018 Oct;97(42):e12553. doi: 10.1097/MD.0000000000012553. |
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| ID | Title | Description |
|---|---|---|
| FG000 | REACH-VN | In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease |
| FG001 | Enhanced Control | Single session with education about nature of dementia |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | REACH-VN | In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data inadvertently not collected for two subjects. |
| 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 | Zarit Burden Inventory-4 | Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
For each participant adverse events were collected for the duration of participation in the study (i.e., up to 3 months)
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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 | REACH-VN | In-home psychosocial intervention to enhance caregiver knowledge and skills and to reduce stress delivered in 4-6 sessions over the course of 2-3 months REACH-VIETNAM: Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ladson Hinton | UCaliforniaDavis | 9167343485 | lwhinton@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 2, 2018 | Jul 7, 2020 | ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2020 | Jul 7, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 2, 2018 | Jul 7, 2020 | Prot_002.pdf |
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Cluster randomized controlled trial
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Scale that assess knowledge of Alzheimer's disease. Range is 0-30. Higher score is better outcome (i.e., more accurate knowledge).
| 3 months |
| Enhanced Control |
Single session with education about nature of dementia |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Data inadvertently not collected for two subjects. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Zarit Burden Inventory - 4 item | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Secondary | Patient Health Questionnaire-4 | Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity). | Posted | Mean | Standard Deviation | units on a scale | 3 months |
|
|
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| Secondary | Alzheimer's Disease Knowledge Scale | Scale that assess knowledge of Alzheimer's disease. Range is 0-30. Higher score is better outcome (i.e., more accurate knowledge). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Enhanced Control | Single session with education about nature of dementia | 0 | 30 | 0 | 30 | 0 | 30 |
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| Unknown or Not Reported |
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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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