NCT06998836

Brief Summary

This study adopted a mixed-methods approach and was conducted in two exploratory phases. The first phase focused on development and involved three focus group interviews with community-dwelling older adults. These qualitative focus group discussions were used to inform the development of a dementia prevention education program based on the analysis results. In the second phase, community-dwelling older adults were recruited to participate in the study. The experimental group received the dementia prevention education program, while the control group received general health education leaflets. Participants were assessed before the intervention, immediately after the intervention, and again three months later. The assessments measured changes in dementia-related knowledge, dementia-related worry, health beliefs, and willingness to engage in preventive actions. This study aimed to examine the effects of the intervention on older adults' dementia knowledge, health beliefs, and willingness to undertake preventive actions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 22, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

dementia preventionhealth beliefs

Outcome Measures

Primary Outcomes (1)

  • Dementia Knowledge Score

    Measured using a validated dementia knowledge questionnaire. The score reflects the participant's understanding of dementia, including symptoms, risk factors, and prevention strategies.

    Baseline, immediately post-intervention, 3-month follow-up

Secondary Outcomes (1)

  • Dementia-Related Worry Score

    Baseline, immediately post-intervention, 3-month follow-up

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants received a structured dementia prevention education program based on focus group findings. The program included interactive sessions on dementia knowledge, risk reduction strategies, and health belief enhancement. Intervention(s): Dementia Prevention Education Program

Behavioral: Dementia prevention education

Control Group

ACTIVE COMPARATOR

Participants received standard health education materials in leaflet form, covering general health maintenance topics not specific to dementia. Intervention(s): General Health Education Leaflet

Other: General Health Education Leaflet

Interventions

Dementia prevention education:A structured dementia prevention education program developed based on qualitative focus group findings. The program includes multiple interactive sessions covering dementia knowledge, health beliefs, risk reduction strategies, and motivation for preventive actions.

Intervention Group

Participants received printed general health education leaflets not specifically related to dementia. The content included general wellness and health maintenance advice.

Control Group

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University of Science and Technology

Taoyuan, 333324, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 31, 2025

Study Start

December 1, 2023

Primary Completion

October 30, 2024

Study Completion

January 13, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations