Dementia
Conditions
Keywords
Family caregiving
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALREACH VN
4-6 sessions delivered over the course of 2-3 months.
BEHAVIORALEnhanced control
A single session providing education about dementia
Sponsors
National Geriatric Hospital
University of Minnesota
National Institute on Aging (NIA)
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* To be eligible for the cluster RCT, the family member will need to be the identified adult (age 18 and above) primary caregiver (i.e. the person spending who provides the most time day-to-day providing care) to an older adult with dementia who is living in the community. In the event that the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 hours/day) to the older adult with dementia will be eligible. * Caregivers will need to score ≥ 6 on the Zarit Burden Inventory 4-item version. * All participants will be living in designated clusters in Hai Duong, Vietnam. * To be eligible, clusters will have a minimum of 5 participants and a maximum of 15 participants. Clusters will be defined as geographic areas serving local health stations.
Exclusion criteria
\- Significant cognitive impairment or sensory deficit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview-12 (ZBI-12) | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months | 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. |
| Patient Health Questionnaire-4 (PHQ-4) | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS-10) | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months | 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. |
| Patient Health Questionnaire-15 (PHQ-15) | Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months | 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. |
Countries
Vietnam
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 160 |
| Enhanced Control A single session focused on education about the nature of dementia. | 170 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Caregivers passed away | 0 | 2 |
| Overall Study | Care recipients passed away | 18 | 13 |
| Overall Study | No longer a primary caregiver | 5 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Total | Enhanced Control | REACH VN |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 11.1 | 61.4 years STANDARD_DEVIATION 11.3 | 61.9 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 330 Participants | 170 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire-15 (PHQ-15) | 9.0 score on a scale STANDARD_DEVIATION 5.3 | 9.0 score on a scale STANDARD_DEVIATION 5.2 | 9.0 score on a scale STANDARD_DEVIATION 5.4 |
| Patient Health Questionnaire-4 (PHQ-4) | 3.7 score on a scale STANDARD_DEVIATION 3.5 | 3.8 score on a scale STANDARD_DEVIATION 3.6 | 3.7 score on a scale STANDARD_DEVIATION 3.4 |
| Perceived Stress Scale (PSS-10) | 13.9 score on a scale STANDARD_DEVIATION 6.75 | 14.1 score on a scale STANDARD_DEVIATION 6.7 | 13.7 score on a scale STANDARD_DEVIATION 6.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 330 Participants | 170 Participants | 160 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 233 Participants | 117 Participants | 116 Participants |
| Sex: Female, Male Male | 97 Participants | 53 Participants | 44 Participants |
| Zarit Burden Interview-12 (ZBI-12) | 21.7 score on a scale STANDARD_DEVIATION 8.5 | 22.0 score on a scale STANDARD_DEVIATION 8.6 | 21.4 score on a scale STANDARD_DEVIATION 8.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 2 / 175 |
| other Total, other adverse events | 0 / 175 | 0 / 175 |
| serious Total, serious adverse events | 0 / 175 | 0 / 175 |
Outcome results
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.
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Population: The analytic sample included participants who completed at least 3-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH VN | Patient Health Questionnaire-4 (PHQ-4) | Baseline | 3.7 score on a scale | Standard Deviation 3.4 |
| REACH VN | Patient Health Questionnaire-4 (PHQ-4) | 3 months | 2.9 score on a scale | Standard Deviation 3 |
| REACH VN | Patient Health Questionnaire-4 (PHQ-4) | 6 months | 3.4 score on a scale | Standard Deviation 3.3 |
| Enhanced Control | Patient Health Questionnaire-4 (PHQ-4) | Baseline | 3.8 score on a scale | Standard Deviation 3.6 |
| Enhanced Control | Patient Health Questionnaire-4 (PHQ-4) | 3 months | 4.4 score on a scale | Standard Deviation 3.7 |
| Enhanced Control | Patient Health Questionnaire-4 (PHQ-4) | 6 months | 3.8 score on a scale | Standard Deviation 3.2 |
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.
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Population: The analytic sample included participants who completed at least 3-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH VN | Zarit Burden Interview-12 (ZBI-12) | Baseline | 21.4 score on a scale | Standard Deviation 8.4 |
| REACH VN | Zarit Burden Interview-12 (ZBI-12) | 3 months | 20.1 score on a scale | Standard Deviation 8.8 |
| REACH VN | Zarit Burden Interview-12 (ZBI-12) | 6 months | 19.2 score on a scale | Standard Deviation 9.1 |
| Enhanced Control | Zarit Burden Interview-12 (ZBI-12) | Baseline | 22.0 score on a scale | Standard Deviation 6.8 |
| Enhanced Control | Zarit Burden Interview-12 (ZBI-12) | 3 months | 22.3 score on a scale | Standard Deviation 8.8 |
| Enhanced Control | Zarit Burden Interview-12 (ZBI-12) | 6 months | 22.4 score on a scale | Standard Deviation 8.6 |
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.
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Population: The analytic sample included participants who completed at least 3-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH VN | Patient Health Questionnaire-15 (PHQ-15) | Baseline | 9.0 score on a scale | Standard Deviation 5.4 |
| REACH VN | Patient Health Questionnaire-15 (PHQ-15) | 3 months | 7.6 score on a scale | Standard Deviation 4.5 |
| REACH VN | Patient Health Questionnaire-15 (PHQ-15) | 6 months | 8.2 score on a scale | Standard Deviation 5.1 |
| Enhanced Control | Patient Health Questionnaire-15 (PHQ-15) | Baseline | 9.0 score on a scale | Standard Deviation 5.2 |
| Enhanced Control | Patient Health Questionnaire-15 (PHQ-15) | 3 months | 9.5 score on a scale | Standard Deviation 5.7 |
| Enhanced Control | Patient Health Questionnaire-15 (PHQ-15) | 6 months | 8.8 score on a scale | Standard Deviation 5.1 |
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.
Time frame: Baseline period at month 0, follow up period at 3 months, and follow up period at 6 months
Population: The analytic sample included participants who completed at least 3-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH VN | Perceived Stress Scale (PSS-10) | Baseline | 13.7 score on a scale | Standard Deviation 6.8 |
| REACH VN | Perceived Stress Scale (PSS-10) | 3 months | 11.9 score on a scale | Standard Deviation 6.9 |
| REACH VN | Perceived Stress Scale (PSS-10) | 6 months | 12.7 score on a scale | Standard Deviation 7.2 |
| Enhanced Control | Perceived Stress Scale (PSS-10) | Baseline | 14.1 score on a scale | Standard Deviation 6.7 |
| Enhanced Control | Perceived Stress Scale (PSS-10) | 3 months | 14.1 score on a scale | Standard Deviation 6.7 |
| Enhanced Control | Perceived Stress Scale (PSS-10) | 6 months | 13.7 score on a scale | Standard Deviation 6.8 |