Mobile-Phone-Based Psychoeducation for Dementia Caregivers in Vietnam

August 1, 2025 updated by: Nguyen Tran To Tran

Evaluating the Efficacy of Mobile-Phone-Based Psychoeducation Intervention on Depression, Anxiety, and Stress in Dementia Caregivers

The goal of this study is to determine whether a mobile phone-based psychoeducational intervention can reduce stress among caregivers of individuals with dementia in Vietnam. The primary research question is: Does the intervention reduce levels of depression, anxiety, and stress among participants? The secondary research question is: Does the intervention increase caregivers' knowledge about dementia, enhance social support, or reduce caregiver burden?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study consists of two groups: an intervention group and a control group. Participants in the intervention group will receive psychoeducational content through the Zalo app on their mobile phones. Weekly, they will be provided with a topic related to dementia care, such as daily caregiving, fall prevention, pressure injury prevention and care, self-care, and coping as a caregiver. Levels of depression, anxiety, and stress will be assessed both before and after the intervention. In the control group, participants will continue receiving standard care.

Study Type

Interventional

Enrollment (Actual)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Ho Chi Minh City
      • Ho Chi Minh, Ho Chi Minh City, Vietnam, 70000
        • Nhan Dan Gia Dinh Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Primary Caregiver Requirement: Participants must have been the primary caregivers of poeple with dementia for at least the past 6 months and plan to continue in this role for the next 6 months of the intervention. Patients with demeentia criteria: Patients must have been diagnosed with dementia for at least 6 months and reside within the community.
  • Language and Education Requirement: Participants must be able to read and understand Vietnamese (with at least a primary education level) and be willing to participate in the study.
  • Smartphone Requirement: Participants must own a smartphone with the Zalo app or be willing to install it (with a brief training session provided for new users).
  • Age Requirement: Participants must be aged 18 years or older.

Exclusion Criteria:

  • Having any acute diseases or cognitive impairment (screening by Mini-Cog) or
  • Having vision or hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Participants will receive usual care and will not receive any intervention
Experimental: Psychoeducation Intervention Group
In the intervention group, participants will receive interventions through the Zalo app on their mobile phones. Weekly, the investigator will send a topic for participants to learn about. Participants will have the opportunity to ask questions and share their feelings or experiences through the Zalo app.
Other: Psychoeducation
Each week, the investigator will send participants one topic through the chat function on the Zalo app. Before receiving the topic, participants will vote on which topic they would like to learn about. The topics will be presented as videos and will cover the following seven areas: providing everyday care, being a caregiver, self-care, knowledge about dementia, fall prevention, pressure injury prevention and care, and managing behavior changes.They may ask questions related to providing dementia care or share their feelings via the chat on the Zalo app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression, anxiety and stress levels
Time Frame: The evaluation period will span from enrollment to the end of the 7-week intervention and continue through three months post-intervention. Assessments will be conducted at three key time points: baseline (prior to the intervention), immediately after the
Levels of depression, anxiety, and stress will be assessed using the Depression, Anxiety, and Stress Scale (DASS-21), which includes three subscales. Each subscale has a scoring range from 0 to 42, resulting in a total possible score between 0 and 126. Higher scores indicate more severe symptoms and worse outcomes.
The evaluation period will span from enrollment to the end of the 7-week intervention and continue through three months post-intervention. Assessments will be conducted at three key time points: baseline (prior to the intervention), immediately after the

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demetia knowledge
Time Frame: The evaluation period will extend over 9 months. Assessments will be conducted at three time points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.
Participants' demntia knowledge will be assessed using a questionnaire adapted from the Northern Ireland Life and Times Survey, consisting of 7 items. The total score ranges from 0 to 7, with higher scores indicating better knowledge and understanding of dementia.
The evaluation period will extend over 9 months. Assessments will be conducted at three time points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.
Caregiver burden
Time Frame: The evaluation period will extend over 9 months. Assessments will be conducted at three key time points: baseline (before the intervention), immediately post-intervention, and three months post- intervention.
Participants will be assessed using the Zarit 4-Item Burden Interview, which consists of four items. Each item is rated on a scale of 1 to 4, with higher scores indicating a greater sense of caregiver burden.
The evaluation period will extend over 9 months. Assessments will be conducted at three key time points: baseline (before the intervention), immediately post-intervention, and three months post- intervention.
Percieved social support
Time Frame: The evaluation will span 9 months, with assessments conducted at three key points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.
Participants will be assessed using the Multidimensional Perceived Social Support Scale (MSPSS), which consists of 12 items. Each item is rated on a 7-point Likert scale, ranging from 1 (very strongly disagree) to 7 (very strongly agree). The total score ranges from 12 to 84, with higher scores indicating greater levels of perceived social support.
The evaluation will span 9 months, with assessments conducted at three key points: baseline (before the intervention), immediately post-intervention, and three months post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nguyen Tran To Tran

Collaborators

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

  • Principal Investigator: Tran TT Nguyen, MD, MSc, University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2024

Primary Completion (Actual)

July 5, 2025

Study Completion (Actual)

July 5, 2025

Study Registration Dates

First Submitted

October 20, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

August 1, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 557-HDDD-DHYD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To ensure participant confidentiality, study results will only be shared upon the request and with the explicit agreement of the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress

Clinical Trials on Psychoeducation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe