DementiaNCT07617883
Dementia Management Training Programme for Primary Health Care Providers
A study testing Structured Dementia Management Competency Training Program and Self-directed Dementia Learning in people with Dementia and Primary Health Care Providers, run by Fujian Medical University.
Trial summary
This study aims to evaluate the effectiveness and implementation outcomes of a dementia management competency training program for primary healthcare workers. A cluster randomized controlled trial will be conducted among primary healthcare institutions in Nanping, Fujian Province, China. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Primary Health Care Providers
- What is being tested?
- Structured Dementia Management Competency Training Program and Self-directed Dementia Learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary healthcare workers aged 18 years or older
- Registered healthcare professionals holding a formal license issued by the national health authority
- At least 1 year of work experience
- Able to access the internet using a computer, tablet, or mobile phone
- Currently working in a participating community health service center or township health center
- Willing to participate in the study and provide written informed consent
Who cannot join
- Personnel who do not directly participate in patient disease management, including logistics or auxiliary staff
- Interns, trainees, or students
- Individuals currently participating in other similar dementia training interventions
- Individuals planning to leave their current institution within the next 12 months
- Individuals who refuse to participate in the study or decline to provide written informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Application and Effectiveness of a RE-AIM-Based Dementia Management Competency Training Program for Primary Health Care Providers: A Cluster Randomized Controlled Trial
This study aims to evaluate the effectiveness and implementation outcomes of a dementia management competency training program for primary healthcare workers. A cluster randomized controlled trial will be conducted among primary healthcare institutions in Nanping, Fujian Province, China. Eligible primary health care providers will be recruited from community health service centers and township health centers.Participating institutions will be randomized in a 1:1 ratio to either a structured dementia management training group or a self-directed learning control group. The intervention group will receive a 12-week blended training program, including online learning, an in-person skills workshop, and case-based practice supervision. The control group will receive self-directed online learning materials. Outcomes will be assessed at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is the change in dementia knowledge, measured using the Dementia Knowledge Assessment Scale. Secondary outcomes include dementia-related attitudes, dementia management practice competency, self-reported dementia management behaviors, objective screening and referral-related indicators, and implementation outcomes based on the RE-AIM framework.
Read the detailed description
This study uses a hybrid effectiveness-implementation design integrating a cluster randomized controlled trial and implementation evaluation. The trial will assess the effectiveness of a dementia management competency training program for primary health care providers at both the individual and organizational levels. At the individual level, the study will evaluate the effects of the training on dementia knowledge, attitudes, practice competency, and dementia management-related clinical behaviors. At the organizational level, the study will examine reach, adoption, implementation quality, and maintenance of the training program in real-world primary healthcare settings.The study will be conducted in community health service centers and township health centers in Nanping, Fujian Province, China. Primary healthcare institutions will serve as clusters. Approximately 16 institutions will be recruited and randomized to the intervention or control group at a 1:1 ratio, with approximately 20 primary health care providers recruited from each institution.The intervention group will receive a 12-week structured blended training program named "Hand in Hand Along the Memory Path". During weeks 1-4, participants will complete seven online learning modules, with a total learning duration of approximately 3 hours. At the end of week 4, participants will attend an in-person skills workshop of approximately 2 hours, focusing on standardized use of cognitive screening and assessment tools. During weeks 5-12, participants will take part in online case-based supervision every two weeks and complete practice tasks related to cognitive screening and dementia management.The control group will receive self-directed online learning materials, including the same knowledge module videos and text-based materials. However, the control group will not receive structured learning tasks, case analysis, knowledge tests, demonstration videos, forum-based support, learning reminders, expert support, toolkits, in-person workshops, or case-based supervision.Quantitative data will be collected at baseline, immediately after the intervention, and 3 months after the intervention. Semi-structured interviews will be conducted 3 months after the intervention to explore participants' experiences, implementation barriers and facilitators, and factors affecting maintenance. Quantitative and qualitative findings will be integrated according to the RE-AIM framework.
- Conditions
- Dementia, Primary Health Care Providers
- Being tested
- Structured Dementia Management Competency Training Program, Self-directed Dementia Learning
- Keywords
- dementia, primary health care providers, dementia management, training, cluster randomized controlled trial, RE-AIM, implementation science, primary care
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Dementia Management Competency Training ProgramGenetic
Also called "Hand in Hand on the Memory Journey" dementia management training programme
The intervention is a 12-week blended training program. During weeks 1-4, participants will complete seven online modules with a total learning duration of approximately 3 hours. At the end of week 4, participants will attend a 2-hour in-person skills workshop focusing on standardized cognitive screening and assessment. During weeks 5-12, participants will participate in online case-based supervision every two weeks and complete practice tasks, including cognitive screening records and dementia management case records.
Self-directed Dementia LearningBehavioural
Participants will be provided with online dementia-related learning materials and will arrange their own learning time and place. No structured completion requirements, assessments, in-person activities, or expert supervision will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Structured Dementia Management Training Group | Experimental | Participants in this group will receive a 12-week structured blended dementia management competency training program. The program includes online learning modules, an in-person skills workshop, case-based supervision, and practice tasks designed to improve dementia knowledge, attitudes, practice competency, and dementia management-related behaviors among primary health care providers. Receives: Genetic: Structured Dementia Management Competency Training Program |
| Self-directed Learning Control Group | Active comparator | Participants in this group will receive self-directed online learning materials related to dementia management. The materials include knowledge module videos and text-based resources but do not include structured learning tasks, case analysis, knowledge tests, demonstration videos, forum-based support, learning reminders, expert support, toolkits, in-person workshops, or case-based supervision. Receives: Behavioral: Self-directed Dementia Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dementia knowledge score
Dementia knowledge will be measured using the Dementia Knowledge Assessment Scale. The primary outcome is the change in total DKAS score from baseline to immediately after the 12-week intervention. Higher scores indicate greater dementia knowledge.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Secondary outcomes (5)
Change in dementia-related attitudes and confidence
Dementia-related attitudes and confidence will be measured using the General Practitioners' Attitudes and Confidence Scale for Dementia. Higher scores indicate more positive attitudes and greater confidence.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Change in dementia management practice competency
Dementia management practice competency was measured using the Dementia Management Practice Competency Scale for Primary Care, which was developed by the research team. Higher scores on the scale indicate greater dementia management practice competency.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Change in self-reported dementia management-related behaviors
Participants will report the frequency of dementia management-related behaviors during the past month, including cognitive screening, identification of suspected cognitive impairment, referral recommendation, communication with patients or family members, and dementia-related health education.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Cognitive screening implementation rate
The cognitive screening implementation rate will be calculated as the number of patients aged 65 years or older who received cognitive screening divided by the total number of patients aged 65 years or older seen during the same period, multiplied by 100%.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Referral recommendation documentation rate
The referral recommendation documentation rate will be calculated as the number of screen-positive patients with documented referral recommendations divided by the total number of screen-positive patients, multiplied by 100%.
Measured: Baseline, immediately after the intervention, and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinying Lin, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617883
- Sponsor's protocol ID
- K2026-04-027
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application and Effectiveness of a RE-AIM-Based Dementia Management Competency Training Program for Primary Health Care Providers: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07617883
- Acronym / sponsor ID
- K2026-04-027
- Conditions
- Dementia, Primary Health Care Providers
- Keywords
- dementia, primary health care providers, dementia management, training, cluster randomized controlled trial, RE-AIM, implementation science, primary care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 1 Jun 2026 (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 aims to evaluate the effectiveness and implementation outcomes of a dementia management competency training program for primary healthcare workers. A cluster randomized controlled trial will be conducted among primary healthcare institutions in Nanping, Fujian Province, China. Eligible primary health care providers will be recruited from community health service centers and township health centers.Participating institutions will be randomized in a 1:1 ratio to either a structured dementia management training group or a self-directed learning control group. The intervention group will receive a 12-week blended training program, including online learning, an in-person skills workshop, and case-based practice supervision. The control group will receive self-directed online learning materials. Outcomes will be assessed at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is the change in dementia knowledge, measured using the Dementia Knowledge Assessment Scale. Secondary outcomes include dementia-related attitudes, dementia management practice competency, self-reported dementia management behaviors, objective screening and referral-related indicators, and implementation outcomes based on the RE-AIM framework.
Detailed description
This study uses a hybrid effectiveness-implementation design integrating a cluster randomized controlled trial and implementation evaluation. The trial will assess the effectiveness of a dementia management competency training program for primary health care providers at both the individual and organizational levels. At the individual level, the study will evaluate the effects of the training on dementia knowledge, attitudes, practice competency, and dementia management-related clinical behaviors. At the organizational level, the study will examine reach, adoption, implementation quality, and maintenance of the training program in real-world primary healthcare settings.The study will be conducted in community health service centers and township health centers in Nanping, Fujian Province, China. Primary healthcare institutions will serve as clusters. Approximately 16 institutions will be recruited and randomized to the intervention or control group at a 1:1 ratio, with approximately 20 primary health care providers recruited from each institution.The intervention group will receive a 12-week structured blended training program named "Hand in Hand Along the Memory Path". During weeks 1-4, participants will complete seven online learning modules, with a total learning duration of approximately 3 hours. At the end of week 4, participants will attend an in-person skills workshop of approximately 2 hours, focusing on standardized use of cognitive screening and assessment tools. During weeks 5-12, participants will take part in online case-based supervision every two weeks and complete practice tasks related to cognitive screening and dementia management.The control group will receive self-directed online learning materials, including the same knowledge module videos and text-based materials. However, the control group will not receive structured learning tasks, case analysis, knowledge tests, demonstration videos, forum-based support, learning reminders, expert support, toolkits, in-person workshops, or case-based supervision.Quantitative data will be collected at baseline, immediately after the intervention, and 3 months after the intervention. Semi-structured interviews will be conducted 3 months after the intervention to explore participants' experiences, implementation barriers and facilitators, and factors affecting maintenance. Quantitative and qualitative findings will be integrated according to the RE-AIM framework.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Dementia Management Training Group | Experimental | Genetic: Structured Dementia Management Competency Training ProgramParticipants in this group will receive a 12-week structured blended dementia management competency training program. The program includes online learning modules, an in-person skills workshop, case-based supervision, and practice tasks designed to improve dementia knowledge, attitudes, practice competency, and dementia management-related behaviors among primary health care providers. |
| Self-directed Learning Control Group | Active comparator | Behavioral: Self-directed Dementia LearningParticipants in this group will receive self-directed online learning materials related to dementia management. The materials include knowledge module videos and text-based resources but do not include structured learning tasks, case analysis, knowledge tests, demonstration videos, forum-based support, learning reminders, expert support, toolkits, in-person workshops, or case-based supervision. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary healthcare workers aged 18 years or older
- Registered healthcare professionals holding a formal license issued by the national health authority
- At least 1 year of work experience
- Able to access the internet using a computer, tablet, or mobile phone
- Currently working in a participating community health service center or township health center
Key exclusion criteria (5 listed)
- Personnel who do not directly participate in patient disease management, including logistics or auxiliary staff
- Interns, trainees, or students
- Individuals currently participating in other similar dementia training interventions
- Individuals planning to leave their current institution within the next 12 months
- Individuals who refuse to participate in the study or decline to provide written informed consent
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 |
|---|---|---|
| Structured Dementia Management Competency Training ProgramAlso: "Hand in Hand on the Memory Journey" dementia management training programmeThe intervention is a 12-week blended training program. During weeks 1-4, participants will complete seven online modules with a total learning duration of approximately 3 hours. At the end of week 4, participants will attend a 2-hour in-person skills workshop focusing on standardized cognitive screening and assessment. During weeks 5-12, participants will participate in online case-based supervision every two weeks and complete practice tasks, including cognitive screening records and dementia management case records. | Genetic | Structured Dementia Management Training Group |
| Self-directed Dementia LearningParticipants will be provided with online dementia-related learning materials and will arrange their own learning time and place. No structured completion requirements, assessments, in-person activities, or expert supervision will be provided. | Behavioural | Self-directed Learning Control Group |
Primary outcome
Change in dementia knowledge score
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Dementia knowledge will be measured using the Dementia Knowledge Assessment Scale. The primary outcome is the change in total DKAS score from baseline to immediately after the 12-week intervention. Higher scores indicate greater dementia knowledge.
5 secondary outcomes
Change in dementia-related attitudes and confidence
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Change in dementia management practice competency
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Change in self-reported dementia management-related behaviors
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Cognitive screening implementation rate
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Referral recommendation documentation rate
Time frame: Baseline, immediately after the intervention, and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Dementia Management Competency Training Program and Self-directed Dementia Learning in people with Dementia and Primary Health Care Providers, run by Fujian Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinying Lin (+86 18965733707, xinyinglin0416@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dementia knowledge score (time frame: Baseline, immediately after the intervention, and 3 months after the intervention). 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 3 Jun 2026.