NCT07617883

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

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

May 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 26, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

dementiaprimary health care providersdementia managementtrainingcluster randomized controlled trialRE-AIMimplementation scienceprimary care

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, immediately after the intervention, and 3 months after the intervention

Secondary Outcomes (5)

  • Change in dementia-related attitudes and confidence

    Baseline, immediately after the intervention, and 3 months after the intervention

  • Change in dementia management practice competency

    Baseline, immediately after the intervention, and 3 months after the intervention

  • Change in self-reported dementia management-related behaviors

    Baseline, immediately after the intervention, and 3 months after the intervention

  • Cognitive screening implementation rate

    Baseline, immediately after the intervention, and 3 months after the intervention

  • Referral recommendation documentation rate

    Baseline, immediately after the intervention, and 3 months after the intervention

Other Outcomes (7)

  • Online course completion rate

    Immediately after the intervention

  • In-person workshop attendance rate

    Immediately after the intervention

  • Practice task completion rate

    Immediately after the intervention

  • +4 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Self-directed Dementia Learning

Interventions

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.

Also known as: "Hand in Hand on the Memory Journey" dementia management training programme
Structured Dementia Management Training Group

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.

Self-directed Learning Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants are blinded to group allocation. All participants are aware that both groups receive training, but do not know whether they are assigned to the intervention or control group. Outcome data are primarily collected via self-administered questionnaires. Personnel responsible for questionnaire distribution and data entry (outcomes assessors) are blinded to group allocation. The primary quantitative analysis is performed independently by a blinded analyst who has no access to qualitative data. Additionally, a semi-structured interview is conducted only with the intervention group for exploratory mixed-methods analysis. The integration of interview findings with quantitative data is performed separately by another individual who is not among the blinded roles described above. Therefore, the mixed-methods analysis does not compromise the blinding of the primary quantitative outcome assessment or analysis. Care providers are not blinded because they are aware of the differences bet
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 1, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share