NCT06700551

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

October 26, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2025

Completed
Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

October 20, 2024

Last Update Submit

August 1, 2025

Conditions

Keywords

dementiacaregiverdepressionanxietystressinterventionpsychoeducationmobile-phone

Outcome Measures

Primary Outcomes (1)

  • Depression, anxiety and stress levels

    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 Outcomes (3)

  • Demetia knowledge

    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

    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

    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.

Study Arms (2)

Psychoeducation Intervention Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Participants will receive usual care and will not receive any intervention

Interventions

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.

Psychoeducation Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nhan Dan Gia Dinh Hospital

Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (3)

  • Bruwer B, Emsley R, Kidd M, Lochner C, Seedat S. Psychometric properties of the Multidimensional Scale of Perceived Social Support in youth. Compr Psychiatry. 2008 Mar-Apr;49(2):195-201. doi: 10.1016/j.comppsych.2007.09.002. Epub 2007 Dec 21.

  • McParland P, Devine P, Innes A, Gayle V. Dementia knowledge and attitudes of the general public in Northern Ireland: an analysis of national survey data. Int Psychogeriatr. 2012 Oct;24(10):1600-13. doi: 10.1017/S1041610212000658. Epub 2012 May 17.

  • Nguyen TTT, Vu LDT, Nguyen TC, Truong KT, Thai TT, Than THN, Nguyen HT. Mobile App Psychoeducation for Dementia Caregivers In Vietnam: A Randomized Controlled Trial. J Multidiscip Healthc. 2025 Oct 23;18:6871-6885. doi: 10.2147/JMDH.S557573. eCollection 2025.

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersDementia

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive Disorders

Study Officials

  • Tran TT Nguyen, MD, MSc

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Psychoeducation
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 20, 2024

First Posted

November 22, 2024

Study Start

October 26, 2024

Primary Completion

July 5, 2025

Study Completion

July 5, 2025

Last Updated

August 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

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

Locations