Family Caregivers
Conditions
Brief summary
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.
Interventions
BEHAVIORALREACH-VIETNAM
Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Family member providing care to someone in household with Alzheimer's disease or a related dementia
Exclusion criteria
* Cognitively impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Inventory-4 | 3 months | Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-4 | 3 months | Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity). |
| Alzheimer's Disease Knowledge Scale | 3 months | Scale that assess knowledge of Alzheimer's disease. Range is 0-30. Higher score is better outcome (i.e., more accurate knowledge). |
Countries
Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Enhanced Control Single session with education about nature of dementia | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | caregiver demented, care recipient died | 3 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | REACH-VN | Enhanced Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 9 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 15 Participants | 32 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 10.4 | 58.7 years STANDARD_DEVIATION 13.9 | 58.8 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 26 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 26 Participants | 51 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 |
| Region of Enrollment Vietnam | 25 participants | 26 participants | 51 participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 44 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
| Zarit Burden Inventory - 4 item | 6.7 units on a scale STANDARD_DEVIATION 2.1 | 6.8 units on a scale STANDARD_DEVIATION 2.3 | 6.7 units on a scale STANDARD_DEVIATION 2.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Zarit Burden Inventory-4
Measure of caregiver burden. Range is 0-16. Higher score indicates worse outcome (i.e., more burden).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REACH-VN | Zarit Burden Inventory-4 | 2.9 score on a scale | Standard Deviation 2.4 |
| Enhanced Control | Zarit Burden Inventory-4 | 5.5 score on a scale | Standard Deviation 3.4 |
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).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REACH-VN | Alzheimer's Disease Knowledge Scale | 19.9 score on a scale | Standard Deviation 3.2 |
| Enhanced Control | Alzheimer's Disease Knowledge Scale | 20.1 score on a scale | Standard Deviation 2 |
Secondary
Patient Health Questionnaire-4
Depressive and anxiety symptoms. Range is 0-12. Higher score indicates worse outcome (i.e., greater symptom severity).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REACH-VN | Patient Health Questionnaire-4 | 0.9 units on a scale | Standard Deviation 1 |
| Enhanced Control | Patient Health Questionnaire-4 | 2.9 units on a scale | Standard Deviation 2.8 |