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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control
Participants in this arm will receive basic information.
Behavioral: 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.
Behavioral: 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alzheimer's Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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