NCT07431528

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 6, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

Storytelling interventionmHealthEarly detectionRural healthVietnam

Outcome Measures

Primary Outcomes (6)

  • Intervention Feasibility: Participant Recruitment and Retention

    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

    Engagement will be assessed using the number of videos watched.

    Month 3, Month 6

  • Intervention Engagement: Exit Interview

    Information on participants' experiences with the intervention will be collected through exit interviews.

    Month 6

  • Intervention Acceptability: System Usability Scale (SUS)

    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)

    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)

    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 Outcomes (3)

  • ADRD Screening/Diagnosis

    Month 3, Month 6

  • Quality of Life: SF-12

    Baseline, Month 3, Month 6

  • Self-Care: The Self-Care of Chronic Illness Inventory (SC-CII)

    Baseline, Month 3, Month 6

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants in this arm will receive basic information.

Behavioral: Basic information

Intervention

EXPERIMENTAL

Participants in this arm will receive the storytelling intervention.

Behavioral: Storytelling intervention

Interventions

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.

Intervention

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.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnam National Geriatric Hospital

Hanoi, Vietnam, Vietnam

Location

Related Publications (4)

  • 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).

    BACKGROUND
  • 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.

    PMID: 39045484BACKGROUND
  • 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.

    PMID: 30596749BACKGROUND
  • 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.

    PMID: 37710164BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Hoa Nguyen, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deogwoon Kim, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 24, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified participant data that will be collected for this study can be obtained by contacting the study PI.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The final dataset will be available from January 2028 to January 2037.
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.

Locations