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

NCT04958707 | Completed Results DMC

• 1 other identifier: AG064688
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Dementia

Outcome Measures

Primary Outcomes (2)

• Phase 1: The Most Common Topics Related to Dementia Patient Care Skills

  The investigators will address these issues by in-deep interviews in phase 1. The most common topics the participants need providing will be listed

  4 months

• Phase 2: The Rate of Recruitment, Retention and Completeness of Outcome Measurements

  The rate of recruitment will be identified by the percentage of participants who agree to participate in the study. The rate of retention will be identified by the percentage of participants who stay in the study. The rate of completeness of the outcome measurements is the percentage of participants who agreed to answer the questionnaires during the study. The rate of recruitment, the rate of participant retention, and the rate of completeness of outcome measurements will be reported in percentages.

  9 months

Secondary Outcomes (4)

• Phase 2: Depression, Anxiety and Stress Levels of the Caregivers

  Baseline, post-intervention (6 months) and three-month follow-up (9 months)

• Dementia Understanding of the Caregivers About Dementia

  Baseline, post-intervention (6 months) and three-months follow-up (9 months)

• Phase 2: Perceived Social Support of the Caregivers

  Baseline, post-intervention (6 months), and three-month follow-up (9 months)

• Phase 2: Perceived Burden

  Baseline, post-intervention (6 months), and three-month follow-up (9 months)

Study Arms (2)

Informational support group

EXPERIMENTAL

The participants in the intervention group will be added to a chat group in the Zalo app, created and managed by one investigator, which is named The Dementia Caregiver Support group. Weekly, the investigator will post one of the topics identified in Phase 1. Before posting the information, the investigator will ask the participants what topic they would like to read and discuss the week after by voting the answer. The posted information will be based on evidence-based resources and consulted by geriatricians, the neurologist, and the psychologist who specialize in dementia. Immediately after posting the topic, one investigator will call the participants to ensure they read and understand the post. The chat group monitor will also collect the questions or comments from the carers who are encouraged to share their feelings or experiences with relevant questions. Then the monitor will post the answers after consulting with the experts.

Other: Information including knowledge and skills related to dementia patient care

Controlled group

ACTIVE COMPARATOR

The participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information.

Other: Usual care

Interventions

Information including knowledge and skills related to dementia patient care OTHER

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.

Informational support group

Usual care OTHER

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

Controlled group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being the primary caregivers of patients with dementia for at least the past 6 months and will continue to be for the next 6 months of the intervention. Dementia patients are those who have been diagnosed with dementia for at least 6 months and are living in the community.
• Being able to read and understand Vietnamese (at least primary education), and willing to participate in the study.
• Having a smartphone that has the Zalo app or willing to have this Zalo app be installed (there will be short training of using Zalo for new users)
• Aged ≥ 18 years

You may not qualify if:

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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead
• National Geriatric Hospital: collaborator
• University of California, Davis: collaborator

Study Sites (2)

Gia Dinh People's Hospital

Ho Chi Minh City, 70000, Vietnam

Location

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (4)

• 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.

  PMID: 22591515 RESULT

• 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.

  PMID: 18243894 RESULT

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 RESULT

• Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

  PMID: 11574710 RESULT

Related Links

• The questionnaire will be used to evaluate dementia understanding of caregivers
• The questionnaire will be used to evaluate perceived social support
• The questionnaire will be used to evaluate stress and coping style
• DASS21 questionnaire will be used in depression, anxiety and stress

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Nguyen Tran To Tran
• Organization: University of Medicine and Pharmacy at Ho Chi Minh City

nguyentrantotran@ump.edu.vn

+84 979635889

Study Officials

• The Than, Dr

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator who interview the participants will be blinded during the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Geriatrics Department

Model Details: Phase 1: 20 in-depth interviews to determine what knowledge and skills related to dementia patient care the carers need providing Phase 2: 60 carers will be randomly allocated into the interventional or controlled group. The intervention duration will be 8 weeks with providing knowledge and skills related to patient care.

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 12, 2021
• Study Start: December 18, 2023
• Primary Completion: July 7, 2024
• Study Completion: October 25, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)