DementiaNCT04958707
A Mobile Phone-based Intervention on Dementia Patients' Caregivers in Vietnam
A study testing Information including knowledge and skills related to dementia patient care in people with Dementia, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Information including knowledge and skills related to dementia patient care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesVietnam
- Study dates
- 18 Dec 2023to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Having any acute diseases or cognitive impairment (screening by Mini-Cog),
- Having vision or hearing impairment
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Gia Dinh People's Hospital
Ho Chi Minh City, 70000
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City, 70000
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Information including knowledge and skills related to dementia patient care, Usual care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information including knowledge and skills related to dementia patient careOther
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.
Usual careOther
Caregivers will be introduce to the website www.alzheimer.org to search for eligible information
| Study group | Role | What they receive |
|---|---|---|
| Informational support group | Experimental | 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. Receives: Other: Information including knowledge and skills related to dementia patient care |
| Controlled group | Active comparator | The participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 9 months
Secondary outcomes (4)
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, post-intervention (6 months), and three-month follow-up (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start18 Dec 2023
- Primary completion7 Jul 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: 20 in-depth interviews to determine what knowledge and skills related to dementia patient care the carers need providing Phase 2: 60 carers will be randomly allocated into the interventional or controlled group. The intervention duration will be 8 weeks with providing knowledge and skills related to patient care.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Geriatric Hospital, University of California, Davis
- Responsible party
- Principal investigator, Nguyen Tran To Tran, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- The Than, Dr, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958707
- Sponsor's protocol ID
- AG064688
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2021
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share the results of the study
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.
PubMed 22591515Bruwer 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.
PubMed 18243894Lovibond 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.
PubMed 7726811Bedard 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.
PubMed 11574710
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Mobile Phone-based Intervention (Zalo App) on Depression, Anxiety, and Stress of Family Caregivers of People With Dementia.
- ClinicalTrials.gov ID
- NCT04958707
- Acronym / sponsor ID
- AG064688
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- National Geriatric Hospital, University of California, Davis
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Phase 1: 20 in-depth interviews to determine what knowledge and skills related to dementia patient care the carers need providing Phase 2: 60 carers will be randomly allocated into the interventional or controlled group. The intervention duration will be 8 weeks with providing knowledge and skills related to patient care.
| Arm | Type | Receives |
|---|---|---|
| Informational support group | Experimental | Other: Information including knowledge and skills related to dementia patient careThe 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. |
| Controlled group | Active comparator | Other: Usual careThe participants will receive usual care, introduced to the website Alzheimer.org to search for eligible information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Having any acute diseases or cognitive impairment (screening by Mini-Cog),
- Having vision or hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Information including knowledge and skills related to dementia patient careThe 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. | Other | Informational support group |
| Usual careCaregivers will be introduce to the website www.alzheimer.org to search for eligible information | Other | Controlled group |
Primary outcome
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills
Time frame: 4 months
The investigators will address these issues by in-deep interviews in phase 1. The most common topics the participants need providing will be listed
Phase 2: The Rate of Recruitment, Retention and Completeness of Outcome Measurements
Time frame: 9 months
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.
4 secondary outcomes
Phase 2: Depression, Anxiety and Stress Levels of the Caregivers
Time frame: Baseline, post-intervention (6 months) and three-month follow-up (9 months)
Dementia Understanding of the Caregivers About Dementia
Time frame: Baseline, post-intervention (6 months) and three-months follow-up (9 months)
Phase 2: Perceived Social Support of the Caregivers
Time frame: Baseline, post-intervention (6 months), and three-month follow-up (9 months)
Phase 2: Perceived Burden
Time frame: Baseline, post-intervention (6 months), and three-month follow-up (9 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22591515McParland 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.
- Results publication: PubMed 18243894Bruwer 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.
- Results publication: PubMed 7726811Lovibond 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.
- Results publication: PubMed 11574710Bedard 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.
- The questionnaire will be used to evaluate dementia understanding of caregiversLink provided by the sponsor.
- The questionnaire will be used to evaluate perceived social supportLink provided by the sponsor.
- The questionnaire will be used to evaluate stress and coping styleLink provided by the sponsor.
- DASS21 questionnaire will be used in depression, anxiety and stressLink provided by the sponsor.
- Individual participant dataSharing planned: No. Share the results of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The Than, Dr principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information including knowledge and skills related to dementia patient care in people with Dementia, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: The Most Common Topics Related to Dementia Patient Care Skills (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04958707, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.