A Mobile Phone-based Intervention on Dementia Patients' Caregivers in Vietnam

NCT04958707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-11

Study results available
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Summary

Background: The growing number of older people with dementia increases demand on informal caregivers who lack information and skills, leading to a high psychological burden in care provision. The proposed smartphone app-based intervention will provide a convenient and feasible solution for reducing depression, stress, and anxiety among dementia carers in Vietnam. This study aims to: (1) understanding the information and skills required by informal carers to populate the content of the intervention and (2) test the clinical feasibility of the intervention and feasibility of a fully- power randomized controlled trial.

Methods: The setting of this study is the geriatrics department in Gia Dinh People's hospital in Ho Chi Minh City. The eligible participants are the informal caregivers of patients with dementia living in the community, who use smartphones. Phase 1 will involve 20 interviews, conducted with 20 dementia carers to determine what information and skills they need most. These findings will be used to design the content of the intervention, which will comprise 8 weekly, online, psycho-educational, group sessions hosted on the Zalo app. Phase 2: using a pilot randomized control trial design, 60 participants will be assigned to the intervention or control group by the block randomization method with a ratio of 1:1. The participants will complete questionnaires at baseline, post-intervention and 3 month post-intervention. Outcome measures include DASS21 (Depression, anxiety and stress 21), dementia understanding, perceived social support, and caregiver's perceived burden. The primary outcome is the feasibility of the intervention and a future fully-power randomized controlled trial including acceptability and perceived effectiveness of the intervention and the rate of recruitment, retention, and completion of assessments.

Conditions

Interventions

OTHER

Information including knowledge and skills related to dementia patient care

The intervention will be administered to the participants via a smartphone app (Zalo app). Weekly, the investigator will post one of the eight topics identified in Phase 1 in the chat room. After posting the topic, one investigator will call the participants to ensure they read and understand the contents.

OTHER

Usual care

Caregivers will be introduce to the website www.alzheimer.org to search for eligible information

Sponsors & Collaborators

  • National Geriatric Hospital

    collaborator OTHER_GOV
  • University of California, Davis

    collaborator OTHER
  • University of Medicine and Pharmacy at Ho Chi Minh City

    lead OTHER

Principal Investigators

  • The Than, Dr · University of Medicine and Pharmacy at Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-18
Primary Completion
2024-07-07
Completion
2024-10-25

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04958707 on ClinicalTrials.gov