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OpenTrials
Completed

NCT Number: NCT05481320

A Phone Intervention for Family Dementia Caregivers in Vietnam

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vietnam National Geriatric Hospital

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REACH VN Phone Intervention

Behavioral

4-6 intervention sessions delivered via phone over the course of 1-3 months.

Enhanced Control

Behavioral

A single phone session providing education about dementia.

Primary outcomes

  1. Zarit Burden Interview-6 (ZBI-6)

    Time frame: Baseline, 3 months

    Change in caregiver burden related to caregiving. Range is 0-24. A higher score indicates a higher burden.

Secondary outcomes

  1. Patient Health Questionnaire-4 (PHQ-4)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Geriatric Hospital
  • National Institute on Aging (NIA)
  • University of Minnesota

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2022
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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