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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG064688 | U.S. NIH Grant/Contract | View source | |
| TR001860 | Other Grant/Funding Number | National Center for Advancing Translational Sciences |
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| Name | Class |
|---|---|
| National Geriatric Hospital | OTHER_GOV |
| University of Minnesota | OTHER |
| National Institute on Aging (NIA) | NIH |
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This is a cluster randomized controlled trial to test the efficacy of a psychosocial 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 test the efficacy of a psychosocial intervention to support Alzheimer's family caregivers in Vietnam. The cluster RCT will test the hypothesis that family caregivers who receive the intervention will show lower psychological distress and lower caregiver burden compared with those in the control group (primary outcomes). In addition, we will conduct secondary analyses to examine whether the intervention group has lower perceived stress and somatic symptoms. Exploratory analyses will be conducted to determine if intervention effects are mediated by caregiver self-efficacy or knowledge gain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REACH VN | Experimental | A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months. |
|
| Enhanced control | Placebo Comparator | A single session focused on education about the nature of dementia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REACH VN | Behavioral | 4-6 sessions delivered over the course of 2-3 months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Zarit Burden Interview-12 (ZBI-12) | The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden. | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
| Patient Health Questionnaire-4 (PHQ-4) | Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity. | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS-10) | In the Perceived Stress Scale-10 (PSS-10), caregivers were asked to rate on a scale of 0 (never) to 4 (very often) how often they have felt a certain way (e.g., been upset because of something that happened unexpectedly) within the past month (total score range: 0-40). A higher sore indicates a higher perceived stress. | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
- Significant cognitive impairment or sensory deficit.
Based on self-representation of gender identity.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vietnam National Geriatric Hospital | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39547823 | Derived | Nguyen H, Nguyen HT, Nguyen NB, Tran D, Harvey DJ, Nguyen BT, Nguyen BTT, Nguyen AN, Nguyen CTH, Nguyen TTH, Nguyen TL, Nguyen ATP, Nguyen NH, Nguyen AL, Luong YH, Nguyen BH, Nguyen PQ, Gitlin LN, Nguyen TA, Pham T, Hinton L. Testing the Efficacy of a Culturally Adapted Family Dementia Caregiver Intervention (REACH VN): Results From a Cluster Randomized Controlled Trial in Northern Vietnam. Am J Geriatr Psychiatry. 2025 May;33(5):535-545. doi: 10.1016/j.jagp.2024.10.011. Epub 2024 Oct 23. | |
| 35534904 |
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41 clusters were randomized. 20 clusters were allocated to enhanced control, and 21 clusters were allocated to REACH VN intervention. 306 caregivers in enhanced control arm and 354 caregivers in REACH VN arm were assess for eligibility. During the subsequent screening process, we excluded one control cluster because the number of enrolled caregivers was below the threshold of five, leaving 40 enrolled clusters at the start of the study (21 intervention and 19 enhanced control).
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| ID | Title | Description |
|---|---|---|
| FG000 | REACH VN | A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months. |
| FG001 | Enhanced Control | A single session focused on education about the nature of dementia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics are reported only for participants who completed the 3-month follow-up. Participants who dropped out before the 3-month follow-up are not included in the baseline analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | REACH VN | A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months. |
| BG001 | Enhanced Control |
| Units | Counts |
|---|---|
| Participants |
|
| 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-12 (ZBI-12) | The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden. | The analytic sample included participants who completed at least 3-month assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
|
For each participant, adverse events were collected for the duration of participation in the study (up to 6 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 | A multi-component behavioral intervention to support family caregivers of persons with dementia. Participants will receive 4-6 sessions in-person or by phone over the course of 2-3 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ladson Hinton, MD | University of California, 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 | May 23, 2023 | Jan 31, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2020 | Dec 21, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2020 | 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 REACH VN, a culturally adapted version of REACH VA, a multi-component dementia family caregiver support intervention that includes psychoeducation, stress reduction, problem-solving, and skill-building.
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| Enhanced control |
| Behavioral |
A single session providing education about dementia |
|
| Patient Health Questionnaire-15 (PHQ-15) | In the Patient Health Questionnaire-15 (PHQ-15), caregivers were asked to rate on a 3-point scale (0 = not bothered at all, 1 = bothered a little, 2 = bothered a lot) how much they have been bothered by somatic symptoms (e.g., stomach pain, headaches) during the past seven days (total score range: 0-30). A higher score indicates a greater severity. | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
| Tran D, Nguyen H, Pham T, Nguyen AT, Nguyen HT, Nguyen NB, Nguyen BH, Harvey D, Gitlin L, Hinton L. Resources for Enhancing Alzheimer's Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam. Trials. 2022 May 9;23(1):377. doi: 10.1186/s13063-022-06228-6. |
| Withdrawal by Subject |
|
| Caregivers passed away |
|
A single session focused on education about the nature of dementia.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Zarit Burden Interview-12 (ZBI-12) | The Zarit Burden Interview-12 (ZBI-12) asked caregivers to rate on a scale of 0 (never) to 4 (nearly always) how often they have experienced feelings of burden or stress related to caregiving (total score range: 0-48). A higher score indicates a higher feel of burden. | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire-4 (PHQ-4) | Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity. | Mean | Standard Deviation | score on a scale |
|
| Perceived Stress Scale (PSS-10) | In the Perceived Stress Scale-10 (PSS-10), caregivers were asked to rate on a scale of 0 (never) to 4 (very often) how often they have felt a certain way (e.g., been upset because of something that happened unexpectedly) within the past month (total score range: 0-40). A higher sore indicates a higher perceived stress. | Mean | Standard Deviation | score on a scale |
|
| Patient Health Questionnaire-15 (PHQ-15) | In the Patient Health Questionnaire-15 (PHQ-15), caregivers were asked to rate on a 3-point scale (0 = not bothered at all, 1 = bothered a little, 2 = bothered a lot) how much they have been bothered by somatic symptoms (e.g., stomach pain, headaches) during the past seven days (total score range: 0-30). A higher scores indicate a greater severity. | Mean | Standard Deviation | score on a scale |
|
| Enhanced Control |
A single session focused on education about the nature of dementia. |
|
|
| Primary | Patient Health Questionnaire-4 (PHQ-4) | Patient Health Questionnaire-4 (PHQ-4) asked caregivers to rate on a scale of 0 (not at all) to 3 (nearly every day) how often they have been bothered by symptoms (e.g., feeling nervous, anxious, or on edge) over the past two weeks (total score range: 0-12). A higher score indicates a higher severity. | The analytic sample included participants who completed at least 3-month assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
|
|
|
| Secondary | Perceived Stress Scale (PSS-10) | In the Perceived Stress Scale-10 (PSS-10), caregivers were asked to rate on a scale of 0 (never) to 4 (very often) how often they have felt a certain way (e.g., been upset because of something that happened unexpectedly) within the past month (total score range: 0-40). A higher sore indicates a higher perceived stress. | The analytic sample included participants who completed at least 3-month assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
|
|
|
| Secondary | Patient Health Questionnaire-15 (PHQ-15) | In the Patient Health Questionnaire-15 (PHQ-15), caregivers were asked to rate on a 3-point scale (0 = not bothered at all, 1 = bothered a little, 2 = bothered a lot) how much they have been bothered by somatic symptoms (e.g., stomach pain, headaches) during the past seven days (total score range: 0-30). A higher score indicates a greater severity. | The analytic sample included participants who completed at least 3-month assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months |
|
|
|
| 0 |
| 175 |
| 0 |
| 175 |
| 0 |
| 175 |
| EG001 | Enhanced Control | A single session focused on education about the nature of dementia. | 2 | 175 | 0 | 175 | 0 | 175 |
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| D001523 | Mental Disorders |
| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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| 3 months |
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| 6 months |
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