Mobile-Phone-Based Psychoeducation for Dementia Caregivers in Vietnam

Not Applicable

Recruiting

• Conditions: Depression, Anxiety; Stress

• Registration Number: NCT06700551
• Lead Sponsor: Nguyen Tran To Tran

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?

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 Timeline

• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-11-19
• Study Start: 2024-11-20
• Study First Posted: 2024-11-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression, anxiety and stress levels	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.
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.	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.
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.	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.

Trial Locations

Locations (1)

Nhan Dan Gia Dinh Hospital; 🇻🇳 Ho Chi Minh, Ho Chi Minh City, Vietnam