N/A
Completed N=80
A Mobile Phone-based Intervention on Dementia Patients' Caregivers in Vietnam
Source: ClinicalTrials.gov NCT04958707 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Phase 1: The Most Common Topics Related to Dementia Patient Care Skills — 15; 12; 18; 18 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: The Most Common Topics Related to Dementia Patient Care Skills |
15; 12; 18; 18; 17; 15 | — |
| PRIMARY Phase 2: The Rate of Recruitment, Retention and Completeness of Outcome Measurements |
30; 30; 27; 27; 27; 27 | — |
| SECONDARY Phase 2: Depression, Anxiety and Stress Levels of the Caregivers |
36; 30.1; 17.3; 34.3; 16.5; 37 | — |
| SECONDARY Dementia Understanding of the Caregivers About Dementia |
3.8; 3.5; 5.8; 2.9; 6.2; 3.1 | — |
| SECONDARY Phase 2: Perceived Social Support of the Caregivers |
9.1; 8.9; 6.3; 9.8; 6.2; 9.7 | — |
| SECONDARY Phase 2: Perceived Burden |
9.1; 8.9; 6.2; 9.8; 6.2; 9.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Having any acute diseases or cognitive impairment (screening by Mini-Cog),
- Having vision or hearing impairment
Data sourced from ClinicalTrials.gov (NCT04958707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.