DementiaNCT06998836
Constructing and Evaluating the Effectiveness of a Community-based Older Adults Dementia Prevention Education Program
A study testing Dementia prevention education and General Health Education Leaflet in people with Dementia, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Dementia prevention education and General Health Education Leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2023to 13 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: (1) 55 years old or above; (2) conscious and able to speak Mandarin and Taiwanese; and (3) willing to participate in this study and complete the consent form -
Exclusion Criteria:(1) diagnosed with dementia; or (2) diagnosed with severe physical or mental illness by a physician.
-
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung University of Science and Technology
Taoyuan City, 333324
About this study
Official title: Exploring the Construction and Intervention Effectiveness of Dementia Prevention Education Programs for Older Adults: A Mixed-Methods Study Based on the Health Belief Model
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.
- Conditions
- Dementia
- Being tested
- Dementia prevention education, General Health Education Leaflet
- Keywords
- dementia prevention, health beliefs
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dementia prevention educationBehavioural
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.
General Health Education LeafletOther
Participants received printed general health education leaflets not specifically related to dementia. The content included general wellness and health maintenance advice.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: General Health Education Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately post-intervention, 3-month follow-up
Secondary outcomes (1)
Dementia-Related Worry Score
Measured using a standardized scale to assess the level of concern or fear participants feel toward developing dementia.
Measured: Baseline, immediately post-intervention, 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Dec 2023
- Primary completion30 Oct 2024
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998836
- Sponsor's protocol ID
- 202301106B0
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Construction and Intervention Effectiveness of Dementia Prevention Education Programs for Older Adults: A Mixed-Methods Study Based on the Health Belief Model
- ClinicalTrials.gov ID
- NCT06998836
- Acronym / sponsor ID
- 202301106B0
- Conditions
- Dementia
- Keywords
- dementia prevention, health beliefs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Chang Gung University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Dementia prevention educationParticipants 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 |
| Control Group | Active comparator | Other: General Health Education LeafletParticipants received standard health education materials in leaflet form, covering general health maintenance topics not specific to dementia. Intervention(s): General Health Education Leaflet |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Dementia prevention educationDementia 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. | Behavioural | Intervention Group |
| General Health Education LeafletParticipants received printed general health education leaflets not specifically related to dementia. The content included general wellness and health maintenance advice. | Other | Control Group |
Primary outcome
Dementia Knowledge Score
Time frame: Baseline, immediately post-intervention, 3-month follow-up
Measured using a validated dementia knowledge questionnaire. The score reflects the participant's understanding of dementia, including symptoms, risk factors, and prevention strategies.
1 secondary outcome
Dementia-Related Worry Score
Time frame: Baseline, immediately post-intervention, 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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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 record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dementia prevention education and General Health Education Leaflet in people with Dementia, run by Chang Gung University of Science and Technology at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dementia Knowledge Score (time frame: Baseline, immediately post-intervention, 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2025.