Dementia
Conditions
Keywords
dementia, family caregiving, phone intervention, non-pharmacological intervention, dementia caregivers
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALREACH VN Phone Intervention
4-6 intervention sessions delivered via phone over the course of 1-3 months.
BEHAVIORALEnhanced Control
A single phone session providing education about dementia.
Sponsors
University of Minnesota
National Geriatric Hospital
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 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* To be eligible to participate, a family member will need to be the identified adult (i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) caregiver (i.e., the person who provides the most time day-to-day care) to an older adult (i.e., age 60 and above) with dementia living in the community. If the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 h/day) to an older adult with dementia will be eligible to participate. * In addition, caregivers will need to score ≥ 6 on the Zarit Burden Interview-4 (ZBI-4). * All participants will be living in clusters in Thach That District, a semi-rural area in Hanoi. Clusters will have a minimum of 3 participants and a maximum of 15 participants.
Exclusion criteria
* Caregivers with difficulties in the consent process due to cognitive impairment or severe sensory impairment (i.e., visual, hearing) * Caregivers don't have access to phone * Individuals who are not yet adults (i.e., infants, children, teenagers) * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview-6 (ZBI-6) | Baseline, 3 months | Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-4 (PHQ-4) | Baseline, 3 months | 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. |
Countries
Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| Enhanced Control A single phone session focused on education about the nature of dementia. | 27 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Care recipent passed away | 0 | 1 |
| Overall Study | No longer a primary caregiver | 3 | 0 |
| Overall Study | Out-of-window assessment | 0 | 1 |
| Overall Study | Unable to contact | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | REACH VN Phone Intervention | Enhanced Control | Total |
|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 11.5 | 54.4 years STANDARD_DEVIATION 11.3 | 55.2 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 27 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Patient Health Questionnaire-4 (PHQ-4) | 4.3 score on a scale STANDARD_DEVIATION 3.4 | 4.8 score on a scale STANDARD_DEVIATION 3.9 | 4.6 score on a scale STANDARD_DEVIATION 3.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 27 Participants | 52 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 | 27 participants | 52 participants |
| Sex: Female, Male Female | 20 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
| Zarit Burden Interview-6 (ZBI-6) | 10.2 score on a scale STANDARD_DEVIATION 3.7 | 10.6 score on a scale STANDARD_DEVIATION 5.2 | 10.4 score on a scale STANDARD_DEVIATION 4.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 27 |
| other Total, other adverse events | 0 / 25 | 0 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 27 |
Outcome results
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.
Time frame: Baseline, 3 months
Population: The analytic sample included participants who completed 3-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH VN Phone Intervention | Zarit Burden Interview-6 (ZBI-6) | Baseline | 10.2 score on a scale | Standard Deviation 3.7 |
| REACH VN Phone Intervention | Zarit Burden Interview-6 (ZBI-6) | 3-month | 8.2 score on a scale | Standard Deviation 4.3 |
| Enhanced Control | Zarit Burden Interview-6 (ZBI-6) | Baseline | 10.6 score on a scale | Standard Deviation 5.2 |
| Enhanced Control | Zarit Burden Interview-6 (ZBI-6) | 3-month | 11.4 score on a scale | Standard Deviation 5.5 |
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.
Time frame: Baseline, 3 months
Population: The analytic sample included participants who completed 3-month assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REACH VN Phone Intervention | Patient Health Questionnaire-4 (PHQ-4) | Baseline | 4.3 score on a scale | Standard Deviation 3.4 |
| REACH VN Phone Intervention | Patient Health Questionnaire-4 (PHQ-4) | 3-month | 2.2 score on a scale | Standard Deviation 2.4 |
| Enhanced Control | Patient Health Questionnaire-4 (PHQ-4) | Baseline | 4.8 score on a scale | Standard Deviation 3.9 |
| Enhanced Control | Patient Health Questionnaire-4 (PHQ-4) | 3-month | 5.3 score on a scale | Standard Deviation 3.6 |