- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07431528
Dementia and Storytelling in Vietnam
February 18, 2026 updated by: Hoa Nguyen, University of Massachusetts, Worcester
Digital Storytelling to Promote Early Dementia Diagnosis in Rural Vietnam
This project aims to improve knowledge regarding Alzheimer's dementia and related dementias (ADRD) among older adults and their caregivers in Vietnam and promote the early diagnosis of ADRD using a digital storytelling intervention.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will develop and test a Digital Storytelling intervention to improve older adults' and caregivers' knowledge of ADRD and to facilitate early diagnosis in rural areas of Vietnam.
The Digital Storytelling Intervention includes interactive multimedia modules for motivating behavior change and improving knowledge and attitudes toward ADRD among older adults and their caregivers through the power and voices of patients with mild to moderate ADRD, older persons with cognitive concerns, and their caregivers.
Mobile Health technology (Computerized Intervention Authoring System - CIAS) will be used to deliver the intervention.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deogwoon Kim, PhD
- Email: deogwoon.kim13@umassmed.edu
Study Contact Backup
- Name: Hoa Nguyen, PhD
- Phone Number: 508-856-8999
- Email: hoa.nguyen@umassmed.edu
Study Locations
-
-
Vietnam
-
Hanoi, Vietnam, Vietnam
- Vietnam National Geriatric Hospital
-
Contact:
- Vu Huyen, MD, PhD
- Email: vuthanhhuyen11@hmu.edu.vn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Older adults (age ≥ 60 years) residing in one of the four participating communities (communities in rural areas of Phu Tho province with minimum distance of 10 km between participating communities)
- Concern about mild cognitive impairment expressed by the participant, caregiver, or healthcare provider, with no formal screening for ADRD
- Ability and willingness to provide informed consent
- Caregivers of eligible participants will be invited to participate after providing written consent.
Exclusion Criteria:
- Current participation in another ADRD study
- Severe cognitive impairment as evaluated by study co-investigators
- Enrollment in palliative care or diagnosis of a terminal illness
- Previous exposure to digital storytelling modules
- Prior participation in the digital storytelling development.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Participants in this arm will receive basic information.
|
Participants will receive basic information about Alzheimer's disease and related dementias (ADRD), issued by the Vietnam Ministry of Health (usual care), at baseline and at Month 3.
|
|
Experimental: Intervention
Participants in this arm will receive the storytelling intervention.
|
Participants will receive a digital storytelling intervention featuring narratives from older adults with mild to moderate Alzheimer's disease and related dementias (ADRD) and their caregivers who have successfully managed the condition.
The stories highlight the benefits of early ADRD diagnosis and strategies for managing diagnostic and care-related challenges.
The intervention will be delivered at baseline and biweekly thereafter for three months via CIAS, with didactic "Learn More" modules provided following the stories.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Feasibility: Participant Recruitment and Retention
Time Frame: Baseline, Month 3, Month 6
|
Feasibility will be assessed using recruitment and retention records, including the number of participants approached, reasons for ineligibility or refusal, and study completion rates.
|
Baseline, Month 3, Month 6
|
|
Intervention Engagement: Interaction Records from CIAS
Time Frame: Month 3, Month 6
|
Engagement will be assessed using the number of videos watched.
|
Month 3, Month 6
|
|
Intervention Engagement: Exit Interview
Time Frame: Month 6
|
Information on participants' experiences with the intervention will be collected through exit interviews.
|
Month 6
|
|
Intervention Acceptability: System Usability Scale (SUS)
Time Frame: Month 3, Month 6
|
SUS is a 10-item, 5-point Likert scale for subjective assessment of usability.
The SUS scores range from 0 to 100.
A score of > 50 indicates that the technology-based interventions are acceptable.
|
Month 3, Month 6
|
|
ADRD Knowledge: Dementia Knowledge Assessment Scale (DKAS)
Time Frame: Baseline, Month 3, Month 6
|
DKAS is a 25-item scale that evaluates dementia knowledge.
Total scores range from 0 to 50, with higher scores indicating greater knowledge.
|
Baseline, Month 3, Month 6
|
|
Attitudes: Dementia Attitude Scale (DAS)
Time Frame: Baseline, Month 3, Month 6
|
DAS is a 20-item, 7-point Likert scale assessing attitudes toward dementia and people living with dementia.
Items are summed, with selected items reverse-coded as appropriate, to calculate a total score (range: 20-140).
Higher scores indicate more positive attitudes.
|
Baseline, Month 3, Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ADRD Screening/Diagnosis
Time Frame: Month 3, Month 6
|
Rates of ADRD screening and diagnosis will be obtained via interviews and through review of participants' medical records by trained study staff.
The diagnosis will be reviewed and confirmed by the study co-investigators (physicians).
|
Month 3, Month 6
|
|
Quality of Life: SF-12
Time Frame: Baseline, Month 3, Month 6
|
The SF-12 is a 12-item scale that assesses health-related quality of life across physical and mental well-being domains.
Scores can range from 0 to 100, with higher scores indicating better quality of life.
|
Baseline, Month 3, Month 6
|
|
Self-Care: The Self-Care of Chronic Illness Inventory (SC-CII)
Time Frame: Baseline, Month 3, Month 6
|
SC-CII is a 29-item scale assessing self-care behaviors across three domains: self-care maintenance, self-care monitoring, and self-care management.
Scores range from 0 to 100, with higher scores indicating better self-care.
|
Baseline, Month 3, Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Hoa Nguyen, PhD, University of Massachusetts, Worcester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nguyen HL, Ha DA, Goldberg RJ, Kiefe CI, Chiriboga G, Ly HN, Nguyen CK, Phan NT, Vu NC, Nguyen QP, Allison JJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam- 12 month follow up results: A cluster randomized controlled feasibility trial. PLoS One. 2018 Dec 31;13(12):e0209912. doi: 10.1371/journal.pone.0209912. eCollection 2018.
- Nguyen HL, Ha DA, Tran OT, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Le TT, Goldberg RJ, Wang B, Tang ET, Chiriboga G, Budhwani H, Allison JJ. Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101123. doi: 10.1016/j.lanwpc.2024.101123. eCollection 2024 Jul.
- Khanh, D. V. D., Van Thang, V., Dung, H., & BinhThang, T. (2015). Prevalence of dementia among the elderly and health care needs for people living with dementiain an urban community of central Vietnam. Vietnam Journal of Public Health-www. vjph. org, 3(1).
- Huynh-Truong HL, Shyu YL, Tran TKL, Huang HL, Do VA. Dementia care practices among community healthcare workers in Vietnam: a qualitative descriptive study. BMC Geriatr. 2023 Sep 14;23(1):562. doi: 10.1186/s12877-023-04199-0.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Study Registration Dates
First Submitted
February 6, 2026
First Submitted That Met QC Criteria
February 18, 2026
First Posted (Actual)
February 24, 2026
Study Record Updates
Last Update Posted (Actual)
February 24, 2026
Last Update Submitted That Met QC Criteria
February 18, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002680
- 25HSR-ADRD-1487208 (Other Grant/Funding Number: Alzheimer's Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified participant data that will be collected for this study can be obtained by contacting the study PI.
IPD Sharing Time Frame
The final dataset will be available from January 2028 to January 2037.
IPD Sharing Access Criteria
The data and associated documentation will be available to qualified academic investigators for non-commercial research under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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