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

Evaluating the Feasibility of a Mobile Phone-based Intervention (Zalo App) on Depression, Anxiety, and Stress of Family Caregivers of People With Dementia.

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia
• Intervention / Treatment: Other: Information including knowledge and skills related to dementia patient care; Other: Usual care

Detailed Description

The study has two phases: the co-design of the content of the intervention (phase 1) and the randomized controlled trial phase (phase 2). The setting and the participants' eligibility criteria are the same for the two phases.

Phase 1 Design: a qualitative study will be conducted on 20 caregivers of patients with dementia to identify what information they most require.

Method: 20 face-to-face interviews will be held and guided by a trained geriatrician, in a private room in the geriatrics department. The open-ended questions are used, including "what difficulties are the participant facing in taking care of the patient with dementia?", "what information do the participant need most?". Each participant will be free to share thoughts. The interviews will be audio-recorded and fully transcribed.

Data analysis: The investigator will use inductive thematic content analysis. The eight most common issues in which the carers need providing information will be determined to shape for the intervention in phase 2.

Phase 2 Study design A parallel-group randomized controlled pilot trial will be used with equal randomization of 1:1 to test the feasibility and the acceptability of the smartphone app-based intervention. Sixty dementia carers, who meet the eligible criteria and are provided written informed consent, will be enrolled in the study and will be allocated to the intervention or usual care group.

Randomization The eligible participants will be assigned to the intervention or control group by an independent statistician, using the block randomization method (blocks of 4).

Intervention The participants in the intervention group will be added to a chat room 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 eight 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 the participants read and understand the post. The chat group monitor will also collect the questions or comments from the carers who are encouraged to share feelings or experiences with relevant questions. Then the investigator will post the answers after consulting with the experts.

Usual care: The participants in the control group will be introduced to the website Alzheimer.org to search for eligible information Procedure The characteristics of the participants (age, gender, educational level, relationship to the care recipient, time of care, etc.) and other assessments will be collected by an independent investigator, who will be blinded through the study.

Measures The participants will perform the Depression, anxiety and stress scale 21 (DASS21) questionnaire via phone call interviews. DASS21 scale contains 21 items, evaluating 3 subscales including depression, anxiety, and stress states over the past week. Higher scores indicate more severity of emotional states. Dementia understanding of the participants will be evaluated at baseline and post-intervention by a questionnaire, originating from the Northern Ireland Life and Time Survey, which was translated into Vietnamese. This questionnaire contains 7 items, for example, "dementia is a normal part of aging" or "dementia can be cured". The response options will be completed with yes/no choices. Four or fewer correct answers will be coded as low understanding, five correct answers medium understanding, and six or more answers as high understanding.

Perceived social support will be assessed using the Multidimensional Scale of Perceived Social Support (MSPSS), comprising 12 self-report items assessing the perceived support from family, friends, or significant others (eg, "There is a person who is around me when I am in need). Each item is scored from 1 (very strongly disagree) to 7 (very strongly agree), based on a 7-point Likert scale. Higher scores indicate higher degrees of perceived social support. This scale will be translated and adapted into Vietnamese.

The caregiver's perceived burden will be evaluated usingthe Zarit 4-item burden interview. Each item is scored from 0 to 4, and higher scores indicate higher levels of burden.

Outcome measurements will be assessed face-to-face at baseline and via phone calls at immediate post-intervention and 3-month follow-up post-intervention.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 70000
    • Recruiting
    • Gia Dinh People's Hospital
    • Contact: The NH Than, PhD; Phone Number: +84 917273669; Email: the2509@ump.edu.vn
    • Contact: Tran TT Nguyen, MSc.; Phone Number: +84 979635889; Email: nguyentrantotran@gmail.com
    • Principal Investigator: The HN Than, PhD
    • Sub-Investigator: Tran TT Nguyen, MSc
    • Sub-Investigator: Tuan C Nguyen, MSc
    • Sub-Investigator: Phong T Vo, MD
    • Sub-Investigator: Lan TD Vu, MD
    • Sub-Investigator: Khoa T Truong
  • Ho Chi Minh City, Vietnam, 70000
    • Recruiting
    • University of Medicine and Pharmacy at Ho Chi Minh City
    • Contact: The NH Than, PhD; Phone Number: +84 917273669; Email: the2509@ump.edu.vn
    • Contact: Tran TT Nguyen, MSc.; Phone Number: +84 979635889; Email: nguyentrantotran@gmail.com
    • Sub-Investigator: Tran TT Nguyen, MSc
    • Sub-Investigator: Tuan C Nguyen, MSc
    • Sub-Investigator: Phong T Vo, MD
    • Sub-Investigator: Lan TD Vu, MD
    • Sub-Investigator: Khoa T Truong
    • Principal Investigator: The NH Than, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Informational support group; 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; 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.
Active Comparator: Controlled group; The participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information.	Other: Usual care; Caregivers will be introduce to the website www.alzheimer.org to search for eligible information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The rate of recruitment, retention and completeness of outcome measurements	The rate of recruitment will be identified by the percentage of participants agree to participate in the study. The rate of retention will be identified by the percentage of participants stay in the study. The rate of completeness the outcome measurements is the percentage of participants agree 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, anxiety and stress levels of the caregivers	The participants will be evaluated by the Depression, anxiety and stress 21 scale. The score of each subscale will range from 0 to 42. The minimum score is 0 and the maximum score is 126. The higher scores indicates worse outcome	9 months. It will be evaluated at baseline, post-intervention and 3-month post intervention
Dementia understanding of the caregivers about dementia	The participant will be evaluated by the questionnaire originating from Northern Ireland Life and Time Survey questionnaire which includes 7 items. The score will range from 0 to 7. A higher score indicates a better outcome.	9 months. It will be evaluated at baseline, post-intervention and 3-month post intervention
Perceived social support of the caregivers	The participant will be evaluated by the Multidimensional perceived social support scale (MSPSS) which includes 12 items. Each item is scored from 1 (very strongly disagree) to 7 (very strongly agree), based on a 7-point Likert scale. The minimum score is 12 and the maximum score is 84. Higher scores indicate higher degrees of perceived social support	9 months. It will be evaluated at baseline, post-intervention and 3-month post intervention
Perceived burden	The participants will be evaluated by the Zarit 4-item burden interview, including 4 items. Each item is scored from 1 to 4. A Higher score indicates a higher feeling of burden.	9 months. It will be evaluated at baseline, post-intervention and 3-month post intervention

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Collaborators: University of California, Davis; National Geriatric Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2023
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: July 1, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: AG064688 (NIA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Share the results of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No