An interventional study of Information including knowledge and skills related to dementia patient care and Usual care in Dementia, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 2 sites in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Supportive care
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 118 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
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 participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information.
Other: Usual 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.
Caregivers will be introduce to the website www.alzheimer.org to search for eligible information
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
Time frame: 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.
Time frame: 9 months
Phase 2: Depression, Anxiety and Stress Levels of the Caregivers
The participants will be evaluated by the Depression, anxiety, and stress 21 scale. The minimum score is 0, and the maximum score is 126. The higher scores indicate worse outcome
Time frame: Baseline, post-intervention (6 months) and three-month follow-up (9 months)
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.
Time frame: Baseline, post-intervention (6 months) and three-months follow-up (9 months)
Phase 2: 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
Time frame: Baseline, post-intervention (6 months), and three-month follow-up (9 months)
Phase 2: 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. The total score ranges from 0 to 16. A Higher score indicates a higher feeling of burden.
Time frame: Baseline, post-intervention (6 months), and three-month follow-up (9 months)
| Milestone | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Phase 1: Qualitative Interviews |
|---|---|---|---|
| Started | 30 | 30 | 20 |
| Completed | 29 | 30 | 20 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Milestone | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Phase 1: Qualitative Interviews |
|---|---|---|---|
| Started | 29 | 30 | 0 |
| Completed | 27 | 27 | 0 |
| Not completed | 2 | 3 | 0 |
| Withdrew: Lost to follow-up | 0 | 3 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
The investigators will address these issues by in-deep interviews in phase 1. The most common topics the participants need providing will be listed
| Participants | The Information Needed by the Caregivers |
|---|---|
| Providing personal care | 15 |
| Managing behavior changes in care recipients. | 12 |
| Help-seeking strategies for caregivers | 18 |
| Self-care for caregivers to maintain their own well-being | 18 |
| Dementia progress and caring skills | 17 |
| Managing comorbidities such as pressure injuries, falls, and infections in care recipients | 15 |
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.
| participants | Informational Support Group | Control Group |
|---|---|---|
| The recruitment rate | 30 | 30 |
| Retention rate | 27 | 27 |
| Completeness of outcome measurements | 27 | 27 |
The participants will be evaluated by the Depression, anxiety, and stress 21 scale. The minimum score is 0, and the maximum score is 126. The higher scores indicate worse outcome
| points | Informational Support Group (Intervention Group) | Control Group |
|---|---|---|
| Baseline | 36 ± 23.4 | 30.1 ± 19.2 |
| Postintervention (6 months) | 17.3 ± 12.5 | 34.3 ± 15.5 |
| 3 months follow-up (9 months) | 16.5 ± 9.5 | 37 ± 15.8 |
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.
| points | Informational Support Group | Control Group |
|---|---|---|
| Baseline | 3.8 ± 1.5 | 3.5 ± 1.2 |
| Postintervention | 5.8 ± 1.3 | 2.9 ± 0.9 |
| 3 months follow-up | 6.2 ± 1.3 | 3.1 ± 0.9 |
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
| score on a scale | Information Support Group | Control Group |
|---|---|---|
| Baseline | 9.1 ± 3.7 | 8.9 ± 3.1 |
| Postintervention | 6.3 ± 2.9 | 9.8 ± 2.4 |
| Three-month follow-up | 6.2 ± 2.4 | 9.7 ± 2.0 |
The participants will be evaluated by the Zarit 4-item burden interview, including 4 items. Each item is scored from 1 to 4. The total score ranges from 0 to 16. A Higher score indicates a higher feeling of burden.
| score on a scale | Informational Support Group | Control Group |
|---|---|---|
| Baseline | 9.1 ± 3.7 | 8.9 ± 3.1 |
| Postintervention | 6.2 ± 2.9 | 9.8 ± 2.4 |
| Three-month follow-up | 6.2 ± 2.4 | 9.7 ± 2.0 |
Collected over 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1: Qualitative Interviews | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Phase 2: Informational Support Group (Intervention Group) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Phase 2: Control Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Phase 1: Qualitative Interviews | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Total |
|---|---|---|---|---|
| Mean | 55.6 ± 10.1 | 56.1 ± 10.1 | 54.1 ± 8.1 | 55.1 ± 9.0 |
| Sex: Female, Male(Participants) | Phase 1: Qualitative Interviews | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Total |
|---|---|---|---|---|
| Female | 18 | 23 | 24 | 65 |
| Male | 2 | 7 | 6 | 15 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1: Qualitative Interviews | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 20 | 30 | 30 | 80 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Phase 1: Qualitative Interviews | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 20 | 30 | 30 | 80 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Phase 1: Qualitative Interviews | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Total |
|---|---|---|---|---|
| Vietnam | 20 | 30 | 30 | 80 |
| Marital status(Participants) | Phase 1: Qualitative Interviews | Phase 2: Informational Support Group (Intervention Group) | Phase 2: Control Group | Total |
|---|---|---|---|---|
| Having a partner | 12 | 16 | 19 | 47 |
| Single/widowed/divorce | 8 | 14 | 11 | 33 |
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University of Medicine and Pharmacy at Ho Chi Minh City