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DementiaNCT05151185

Establishment of Core Competence and Training Model for Dementia Case Management

A study testing Case Management Service Program in people with Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to develop the core competence and training model for case management of dementia. This study is the second phase of the project. The first year is the establishment of the training program and the pilot-test stage. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Dementia
What is being tested?
Case Management Service Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 siteTaiwan
Study dates
3 Nov 2022to Dec 2023
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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Dementia Case Managers:
  • Be at least 20 years old and could communicate in Chinese or Taiwanese.
  • Currently work for dementia center, dementia care center, or Community-Based Dementia Care Center in Taiwan.
  • Dementia family caregivers:
  • Be at least 20 years old and could communicate in Chinese or Taiwanese.
  • Primary caregivers
  • The people with dementia under care are diagnosed with dementia Clinical Dementia Rating Scale(CDR) 0.5 or higher.
  • Live in northern Taiwan(including Taipei, New Taipei, Taoyuan, and Hsinchu).

Who cannot join

  • Dementia Case Managers:
  • No longer working for dementia center, dementia care center, or Community-Based Dementia Care Center in Taiwan.
  • Dementia family caregivers:
  • The people with dementia under care live in a long-term care facility or nursing home.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Chang Gung University of Science and Technology

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: Establishment of Core Competence and Training Model for Dementia Case Management: Phase 2

The purpose of this study is to develop the core competence and training model for case management of dementia. This study is the second phase of the project. The first year is the establishment of the training program and the pilot-test stage. The second year is the project implementation and effectiveness evaluation stage, the intervention effectiveness evaluation of the training course for dementia case managers will be conducted.

Read the detailed description

The purpose of this study is to develop the core competence and training model for case management of dementia. In the previous year (phase I), the needs and competence assessment stage, the investigators are conducting a survey of the connotation and needs of dementia case management, and explore the role functions and competencies of dementia case managers as the basis for developing the training program.

This study is the second phase of the project. The first year is the establishment of the training program and the pilot-test stage. The data collected in the previous period will be integrated to plan a preliminary training program structure, and then the content and training methods of the training program for dementia case managers will be established using the Delphi method. Then, use this training program to carry out the pilot test of the dementia case managers training program. The second year is the project implementation and effectiveness evaluation stage, the intervention effectiveness evaluation of the training course for dementia case managers will be conducted. The results of this study will serve as a reference for the training program of dementia case managers in future.

Conditions
Dementia
Being tested
Case Management Service Program
Keywords
dementia, case management, core competence, training program
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Case Management Service ProgramOther

    The dementia case manager in experiment group will undergo training (Competency-based Dementia Case Management Train-the-trainer Program; CDCMTP); The family caregiver in experiment group will receive competency-based Dementia Case Management Service Program: Needs Assessment, Intervention, evaluation and follow up, etc. The case management program is provided by a trained case manager in a dementia clinic, as well as telephone consultations and follow-up are provided.

Study groups in NCT05151185
Study groupRoleWhat they receive
Control groupNo interventionThe dementia case manager in the control group undergo existing training. The family caregiver in the control group receive routine service.
training programExperimentalThe dementia case manager in experiment group will undergo training (Competency-based Dementia Case Management Train-the-trainer Program; CDCMTP); The family caregiver in experiment group will receive competency-based Dementia Case Management Service Program.
Receives: Other: Case Management Service Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dementia Care Professional Competency Assessment Scale

    1. The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). The scale is used to evaluate dementia care competency in dementia case managers (Huang et al., 2018).
    2. This Scale contains nine subscales (74 items), using Likert 5-point Likert scale from 1 to 5. A higher score means better competencies.
    3. This scale is used to evaluate the competence of dementia case managers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, and 6 months. Change from Baseline Dementia Care Professional Competency at 1, 3, and 6 months.

  2. Problem solving, Teamwork Competency Assessment Scale

    1. The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 106-2511-S-255-002-MY3). There are 22 questions on this scale. The scale is used to evaluate the problem solving and teamwork competency of Dementia case managers. (Huang et al. 2018).
    2. This scale contains 22 items.10 items were used to evaluate problem solving competencies, 12 items were used to evaluate teamwork competencies. A higher score means better competencies.
    3. This scale is used to evaluate the competence of dementia case managers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, and 6 months. Change from Baseline Problem solving, Teamwork Competency at 1, 3, and 6 months.

  3. Caregiver Preparedness Scale - Professional version

    1. This scale was developed by our research team by referring to The Preparedness for Caregiving Scale (PCS) developed by Archbold et al. This scale is to rate how well prepared they believe they are for caregiving (Archbold et al.,1990; Huang, Kuo, et al., 2013).
    2. This 11-items scale was scored on a 5-point Likert scale from 1 (unprepared) to 5 (well prepared). Scores range from 11 to 55, with higher scores representing greater preparedness for caregiving tasks. A final question is an open-end question.
    3. This scale is used to evaluate the competence of dementia case managers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, and 6 months. Change from Baseline Caregiver Preparedness - Professional at 1,3, and 6 months.

  4. Qualitative interview

    Conduct qualitative interviews with dementia case managers, focusing on the effectiveness of the training program.

    Measured: The investigators will conduct qualitative interviews after intervention for 1 month. Change from Baseline Qualitative interview at 1 month.

  5. Demographic data of persons with dementia and family caregivers

    1. The persons with dementia include age, gender, education level, marital status, period of illness, etc.
    2. The family caregivers include age, gender, education level, marital status, etc.

    Measured: We will collect demographic data of dementia and family caregivers on the day before the start date of intervention.

  6. 36-item short-form health survey (SF-36)

    1. Ware J. E., \& Sherbourne, C. D. (1992). The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Medical care, 473-483.
    2. The SF-36 measures eight scales, with higher scores representing the greater quality of life.
    3. This scale is used to assess the quality of life for people with dementia and their family caregivers .

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, 6, and 12 months.Change from Baseline 36-item short-form health survey at 1,3,6 and 12 months.

  7. Dementia Case Management Needs Scale

    1. The scale was developed by our past research that was supported by the Taiwan Ministry of Science and Technology (Grant Number 109-2511-H-255-004 -). This scale was used to Investigate the needs of case management for family caregivers with dementia in the community.
    2. This Scale uses Likert 5-point Likert scale from 1 to 5, with higher scores representing greater demand for family caregivers.
    3. This scale is used to evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, 6, and 12 months. Change from Baseline Dementia Case Management Needs at 1, 3, 6, and 12 months.

  8. Cohen-Mansfield Agitation Inventory (CMAI)

    1. Dementia's behavioral problems were measured by the Chinese version of the CMAI, community form (Cohen-Mansfield, J et al. 1989, 1991, C.K.Y. Lai, pers. comm.).
    2. The 43-item CMAI has four subscales that assess four groups of behavioral problems: physically non-aggressive behavior, physically aggressive behavior, verbally aggressive behavior and verbally non-aggressive behavior. Each item's score ranges from 1 (never happened) to 7 (several times in an hour). Scores can range from 43-301, with higher scores representing more frequent or more types of behavioral problems.
    3. This scale is used to evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, 6, and 12 months. Change from Baseline behavioral problems (CMAI) at 1, 3, 6, and 12 months.

  9. Agitation Management Self-Efficacy Scale (AMSS)

    1. Family caregivers' self-efficacy for caring agitated behavior of older people with dementia was measured by the Agitation Management Self-Efficacy Scale (AMSS), which was developed by our research team. (Huang, Shyu, Chen, \& Hsu, 2009)
    2. For each of the 43 behavioral problems identified by the Chinese version of the CMAI, caregivers are asked how confident they feel about handling the problem. Each AMSS item is scored on a Likert-type scale from 1 (not able to handle at all) to 5 (totally able to handle). Total scores range from 43-215. Higher scores represent greater caregiver self-efficacy to handle behavioral problems.
    3. This scale is used to evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, 6, and 12 months. Change from Baseline caregiver self-efficacy to handle behavioral problems (AMSS) at 1, 3, 6, and 12 months.

  10. Caregiver Preparedness Scale - family caregiver version

    1. This scale was developed by our research team by referring to The Preparedness for Caregiving Scale (PCS) developed by Archbold et al. This scale is to rate how well prepared they believe they are for caregiving (Archbold et al.,1990; Huang, Kuo, et al., 2013).
    2. This 11-items scale was scored on a 5-point Likert scale from 1 (unprepared) to 5 (well prepared). Scores range from 11 to 55, with higher scores representing greater preparedness for caregiving tasks. A final question is an open-end question.
    3. This scale is used to evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, 6, and 12 months. Change from Baseline Caregiver Preparedness -family caregiver at 1, 3, 6, and 12 months.

  11. Activities of daily living (ADL)

    1. García-Casal JA, Loizeau A, Csipke E, Franco-Martín M, Perea-Bartolomé MV, Orrell M. Computer-based cognitive interventions for people living with dementia: a systematic literature review and meta-analysis. Aging Ment Health.2016; 25: 1-14.
    2. The ADL refers to activities oriented toward taking care of one's own body.
    3. This scale assesses 10 items related to the activity including feeding, transfer, grooming, toilet use, bathing, mobility, stairs, dressing, bowels, and bladder. Each item is scored from 0 (maximum disability and dependency) to 20 (maximum strength and independence). Scores can range from 0 to 100, with higher scores representing more independence.
    4. This scale is used to evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, 6, and 12 months. Change from Baseline ADL at 1, 3, 6, and 12 months.

  12. Instrumental Activities of Daily Living (IADL)

    1. Ryu SY, Lee SB, Kim TW, Lee TJ. Subjective memory complaints, depressive symptoms and instrumental activities of daily living in mild cognitive impairment. Int Psychogeriatr. 2015; 11: 1-8.
    2. The IADL refers to activities oriented toward interacting with the environment and that are often complex-generally optional in nature.
    3. This scale assesses 8 items related to the activity including the ability to use a phone, shopping, the model of transportation, meal preparation, housekeeping, laundry, the responsibility for owns medication, and the ability to handle finance. Each item is scored from 0 (dependency) to 3 (independence). Scores can range from 0 to 24, with higher scores representing more independence.
    4. This scale is used to evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, 6, and 12 months. Change from Baseline IADL at 1, 3 ,6, and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2021
  2. Study start3 Nov 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05151185
Sponsor's protocol ID
MOST 110-2511-H-255 -003 -MY2
Other IDs
NMRPF3L0051
Status last verified
Aug 2023
First submitted
31 Oct 2021
Last updated
18 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huang HL, Liao YT, Kung PC, Shyu YL, Hsu WC, Hsu JL. Caregiving management needs and predictors for family caregivers of persons with dementia: a cross-sectional study. BMC Geriatr. 2024 Aug 30;24(1):724. doi: 10.1186/s12877-024-05316-3.

    PubMed 39215257

Questions about this trial

What is this clinical trial studying?

A study testing Case Management Service Program in people with Dementia, run by Chang Gung Memorial Hospital 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?

The sponsor lists 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Aug 2023. 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?

Results are not available in the source record.

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 Care Professional Competency Assessment Scale (time frame: The investigators will evaluate before the intervention, and after intervention for 1, 3, and 6 months. Change from Baseline Dementia Care Professional Competency at 1, 3, and 6 months.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05151185, which also lists 1 linked publication.

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 18 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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