Trial Outcomes & Findings for A Mobile Phone-based Intervention on Dementia Patients' Caregivers in Vietnam (NCT NCT04958707)
NCT ID: NCT04958707
Last Updated: 2025-08-11
Results Overview
The investigators will address these issues by in-deep interviews in phase 1. The most common topics the participants need providing will be listed
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
4 months
Results posted on
2025-08-11
Participant Flow
Phase 1 (Qualitative interviews): Twenty qualitative interviews were conducted to explore the needs of caregivers of people with dementia. Phase 2 (Pilot RCT): We invited 60 eligible participants, who were then randomly assigned to either the control or intervention group.
Participant milestones
| Measure |
Phase 2: Informational Support Group (Intervention 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.
|
Phase 2: Control Group
The participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information.
|
Phase 1: Qualitative Interviews
Twenty qualitative interviews were conducted to explore the needs of caregivers of people with dementia.
|
|---|---|---|---|
|
Post Intervention
STARTED
|
30
|
30
|
20
|
|
Post Intervention
COMPLETED
|
29
|
30
|
20
|
|
Post Intervention
NOT COMPLETED
|
1
|
0
|
0
|
|
3 Months Follow- up
STARTED
|
29
|
30
|
0
|
|
3 Months Follow- up
COMPLETED
|
27
|
27
|
0
|
|
3 Months Follow- up
NOT COMPLETED
|
2
|
3
|
0
|
Reasons for withdrawal
| Measure |
Phase 2: Informational Support Group (Intervention 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.
|
Phase 2: Control Group
The participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information.
|
Phase 1: Qualitative Interviews
Twenty qualitative interviews were conducted to explore the needs of caregivers of people with dementia.
|
|---|---|---|---|
|
Post Intervention
Withdrawal by Subject
|
1
|
0
|
0
|
|
3 Months Follow- up
Lost to Follow-up
|
0
|
3
|
0
|
|
3 Months Follow- up
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
A Mobile Phone-based Intervention on Dementia Patients' Caregivers in Vietnam
Baseline characteristics by cohort
| Measure |
Phase 1: Qualitative Interviews
n=20 Participants
The needs for knowledge and caregiving skills in dementia care were explored through in-depth interviews
|
Phase 2: Informational Support Group (Intervention Group)
n=30 Participants
Participants in the intervention group will be added to a chat group on the Zalo smartphone app, named The Dementia Caregiver Support Group. This group will be created and managed by one of the investigators. Each week, the investigator will post one of the eight topics identified in Phase 1. Prior to each post, participants will be invited to vote on which topic they would like to read and discuss the following week.
The educational content shared will be based on evidence-based resources and reviewed by specialists, including geriatricians, a neurologist, and a psychologist with expertise in dementia care. Immediately after posting, the investigator will contact each participant to ensure that they have read and understood the content.
Participants will be encouraged to share their feelings, experiences, and questions in the chat group. The investigator will monitor the chat, collect comments and questions, and post expert-reviewed responses.
The intervention will last for seven weeks, covering seven topics: Feeding and incontinence care; Managing behavioral changes; Pressure injury prevention and care; Fall prevention; Understanding dementia progression; Preparing caregivers for future care; Caregiver self-care
|
Phase 2: Control Group
n=30 Participants
The participants will receive usual care and be introduced to the website Alzheimer.org to search for eligible information.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Vietnam
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Marital status
Having a partner
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Marital status
Single/widowed/divorce
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe investigators will address these issues by in-deep interviews in phase 1. The most common topics the participants need providing will be listed
Outcome measures
| Measure |
The Information Needed by the Caregivers
n=20 Participants
We conducted in-depth interviews with 20 caregivers to identify the information and skills they need while providing care.
|
Control Group
The participants in the control group will be introduced to the website Alzheimer.org to search for eligible information
|
|---|---|---|
|
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills
Providing personal care
|
15 Participants
|
—
|
|
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills
Managing behavior changes in care recipients.
|
12 Participants
|
—
|
|
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills
Help-seeking strategies for caregivers
|
18 Participants
|
—
|
|
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills
Self-care for caregivers to maintain their own well-being
|
18 Participants
|
—
|
|
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills
Dementia progress and caring skills
|
17 Participants
|
—
|
|
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills
Managing comorbidities such as pressure injuries, falls, and infections in care recipients
|
15 Participants
|
—
|
PRIMARY outcome
Timeframe: 9 monthsThe 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.
Outcome measures
| Measure |
The Information Needed by the Caregivers
n=31 Participants
We conducted in-depth interviews with 20 caregivers to identify the information and skills they need while providing care.
|
Control Group
n=31 Participants
The participants in the control group will be introduced to the website Alzheimer.org to search for eligible information
|
|---|---|---|
|
Phase 2: The Rate of Recruitment, Retention and Completeness of Outcome Measurements
The recruitment rate
|
30 participants
|
30 participants
|
|
Phase 2: The Rate of Recruitment, Retention and Completeness of Outcome Measurements
Retention rate
|
27 participants
|
27 participants
|
|
Phase 2: The Rate of Recruitment, Retention and Completeness of Outcome Measurements
Completeness of outcome measurements
|
27 participants
|
27 participants
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (6 months) and three-month follow-up (9 months)Population: In the intervention group, one participant withdrew during the intervention, and two participants withdrew after the intervention. In the control group, three participants were lost to follow-up.
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
Outcome measures
| Measure |
The Information Needed by the Caregivers
n=30 Participants
We conducted in-depth interviews with 20 caregivers to identify the information and skills they need while providing care.
|
Control Group
n=30 Participants
The participants in the control group will be introduced to the website Alzheimer.org to search for eligible information
|
|---|---|---|
|
Phase 2: Depression, Anxiety and Stress Levels of the Caregivers
Baseline
|
36 points
Standard Error 23.4
|
30.1 points
Standard Error 19.2
|
|
Phase 2: Depression, Anxiety and Stress Levels of the Caregivers
Postintervention (6 months)
|
17.3 points
Standard Error 12.5
|
34.3 points
Standard Error 15.5
|
|
Phase 2: Depression, Anxiety and Stress Levels of the Caregivers
3 months follow-up (9 months)
|
16.5 points
Standard Error 9.5
|
37 points
Standard Error 15.8
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (6 months) and three-months follow-up (9 months)Population: In the intervention group, one participant withdrew during the intervention, and two participants withdrew after the intervention. In the control group, three participants were lost to follow-up.
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.
Outcome measures
| Measure |
The Information Needed by the Caregivers
n=30 Participants
We conducted in-depth interviews with 20 caregivers to identify the information and skills they need while providing care.
|
Control Group
n=30 Participants
The participants in the control group will be introduced to the website Alzheimer.org to search for eligible information
|
|---|---|---|
|
Dementia Understanding of the Caregivers About Dementia
Baseline
|
3.8 points
Standard Deviation 1.5
|
3.5 points
Standard Deviation 1.2
|
|
Dementia Understanding of the Caregivers About Dementia
Postintervention
|
5.8 points
Standard Deviation 1.3
|
2.9 points
Standard Deviation 0.9
|
|
Dementia Understanding of the Caregivers About Dementia
3 months follow-up
|
6.2 points
Standard Deviation 1.3
|
3.1 points
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (6 months), and three-month follow-up (9 months)Population: In the intervention group, one participant withdrew during the intervention, and two participants withdrew after the intervention. In the control group, three participants were lost to follow-up.
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
Outcome measures
| Measure |
The Information Needed by the Caregivers
n=30 Participants
We conducted in-depth interviews with 20 caregivers to identify the information and skills they need while providing care.
|
Control Group
n=30 Participants
The participants in the control group will be introduced to the website Alzheimer.org to search for eligible information
|
|---|---|---|
|
Phase 2: Perceived Social Support of the Caregivers
Baseline
|
9.1 score on a scale
Standard Deviation 3.7
|
8.9 score on a scale
Standard Deviation 3.1
|
|
Phase 2: Perceived Social Support of the Caregivers
Postintervention
|
6.3 score on a scale
Standard Deviation 2.9
|
9.8 score on a scale
Standard Deviation 2.4
|
|
Phase 2: Perceived Social Support of the Caregivers
Three-month follow-up
|
6.2 score on a scale
Standard Deviation 2.4
|
9.7 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, post-intervention (6 months), and three-month follow-up (9 months)Population: In the intervention group, one participant withdrew during the intervention, and two participants withdrew after the intervention. In the control group, three participants were lost to follow-up.
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.
Outcome measures
| Measure |
The Information Needed by the Caregivers
n=30 Participants
We conducted in-depth interviews with 20 caregivers to identify the information and skills they need while providing care.
|
Control Group
n=30 Participants
The participants in the control group will be introduced to the website Alzheimer.org to search for eligible information
|
|---|---|---|
|
Phase 2: Perceived Burden
Baseline
|
9.1 score on a scale
Standard Deviation 3.7
|
8.9 score on a scale
Standard Deviation 3.1
|
|
Phase 2: Perceived Burden
Postintervention
|
6.2 score on a scale
Standard Deviation 2.9
|
9.8 score on a scale
Standard Deviation 2.4
|
|
Phase 2: Perceived Burden
Three-month follow-up
|
6.2 score on a scale
Standard Deviation 2.4
|
9.7 score on a scale
Standard Deviation 2.0
|
Adverse Events
Phase 1: Qualitative Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Informational Support Group (Intervention Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nguyen Tran To Tran
University of Medicine and Pharmacy at Ho Chi Minh City
Phone: +84 979635889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place