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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG064688 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| National Geriatric Hospital | OTHER_GOV |
| National Institute on Aging (NIA) | NIH |
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This is a cluster randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN, a psychosocial culturally adapted Alzheimer's family caregiving intervention, to support family caregivers of persons living with dementia in Vietnam.
The objective of this study is to conduct a cluster randomized controlled trial (RCT) to examine the feasibility, acceptability, and preliminary efficacy of the phone version of REACH VN (Resources for Enhancing Alzheimer's Caregiver Health in Vietnam), a psychosocial culturally adapted Alzheimer's family caregiving intervention that will be delivered over the phone with an enhanced control as the comparison. The pilot cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower caregiver burden (primary outcome) and lower depressive/anxiety symptoms (secondary outcome) compared with those in the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH VN Phone Intervention | Experimental | A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers. |
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| Enhanced control | Placebo Comparator | A single phone session focused on education about the nature of dementia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH VN Phone Intervention | Behavioral | 4-6 intervention sessions delivered via phone over the course of 1-3 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Interview-6 (ZBI-6) | Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-4 (PHQ-4) | Change in caregiver psychological distress (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a greater level of psychological distress. | Baseline, 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Geriatric Hospital | Hanoi | Vietnam |
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| ID | Title | Description |
|---|---|---|
| FG000 | REACH VN Phone Intervention | A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers. |
| FG001 | Enhanced Control | A single phone session focused on education about the nature of dementia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | REACH VN Phone Intervention | A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers. |
| 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, Continuous | Mean |
| 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 Interview-6 (ZBI-6) | Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden. | The analytic sample included participants who completed 3-month assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
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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 Phone Intervention | A multicomponent behavioral intervention to support family caregivers of persons with dementia. The enrollment session (session 0) will be conducted face-to-face. Thereafter, participants will receive 4-6 intervention sessions by phone with either audio or video call over the course of 1-3 months. The sessions will occur every 1-2 weeks depending on the needs and availability of family caregivers. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ladson Hinton, MD | UC Davis | 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2022 | Dec 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2022 | Dec 21, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2022 | Dec 21, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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The active treatment is a REACH VN phone intervention, a culturally adapted version of REACH VA, a multicomponent dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
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| Enhanced Control | Behavioral | A single phone session providing education about dementia. |
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| Out-of-window assessment |
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| No longer a primary caregiver |
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| Unable to contact |
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| BG001 | Enhanced Control | A single phone session focused on education about the nature of dementia. |
| BG002 | Total | Total of all reporting groups |
| years |
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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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| Region of Enrollment | Number | participants |
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| Zarit Burden Interview-6 (ZBI-6) | This measures caregiver burden related to caregiving before intervention. Range is 0-24. A higher score indicates a higher burden. | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire-4 (PHQ-4) | This measures caregiver psychological distress before intervenion (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a great level of psychological distress. | Mean | Standard Deviation | score on a scale |
|
| Enhanced Control |
A single phone session focused on education about the nature of dementia. |
|
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| Secondary | Patient Health Questionnaire-4 (PHQ-4) | Change in caregiver psychological distress (e.g., depressive and anxiety symptoms). Range is 0-12. A higher score indicates a greater level of psychological distress. | The analytic sample included participants who completed 3-month assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Enhanced Control | A single phone session focused on education about the nature of dementia. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D001523 | Mental Disorders |