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DementiaNCT05131789

Establishment and Application of Dementia Case Management Information System: A Preliminary Study

A study testing dementia case management information system in people with Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to develop and examine the preliminary effects of an information system for facilitating dementia case management in the home setting. This study is the second phase of the project. The first year is the development stage of the information system. 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?
dementia case management information system
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTaiwan
Study dates
2 Feb 2023to 16 May 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(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 and Application of Dementia Case Management Information System: A Preliminary Study - Phase 2

The purpose of this study is to develop and examine the preliminary effects of an information system for facilitating dementia case management in the home setting.

This study is the second phase of the project. The first year is the development stage of the information system. In the second year, the investigators will conduct a pilot study to examine the effectiveness of the case management information system.

Read the detailed description

The purpose of this study is to develop and examine the preliminary effects of an information system for facilitating dementia case management in the home setting. In the previous research (phase I), a mixed method was used to explore the content of case management and assess the needs of the information system.

This study is the second phase of the project. The first year is the development stage of the information system. Based on the data collected in the previous research (phase I), the content and method of dementia case management will be established by the Delphi method, and then the dementia case management information system will be constructed accordingly. In the second year, the investigators will conduct a pilot study to examine the effectiveness of the case management information system.

Conditions
Dementia
Being tested
dementia case management information system
Keywords
Dementia, Case management, Information system
Medical subject headings
Dementia

What participants receive

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

  • dementia case management information systemProcedure or surgery

    The investigators will develop an information system based on the data collected in our previous research, the content and method of dementia case management which will be established by the Delphi method, and then the dementia case management information system will be constructed accordingly.

Study groups in NCT05131789
Study groupRoleWhat they receive
Information System GroupExperimentalThe dementia case managers in the experiment group use information system to perform case management.
Receives: Procedure: dementia case management information system

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. Basic information of dementia and family caregivers

    1. The persons with dementia include age, gender, education level, marital status, degree of dementia, period of illness, Mini-Mental State Examination (MMSE), etc. The family caregivers include age, gender, education level, marital status, etc.
    2. This scale is used to evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention.

  5. 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, and 6 months. Change from Baseline behavioral problems (CMAI) at 1, 3, and 6 months.

  6. 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, and 6 months. Change from Baseline caregiver self-efficacy to handle behavioral problems (AMSS) at 1, 3, and 6 months.

  7. 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, and 6 months. Change from Baseline ADL at 1, 3, and 6 months.

  8. 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, and 6 months. Change from Baseline IADL at 1, 3, and 6 months.

  9. Caregiver competence Scale

    1. This scale was developed by our research team by referring to The measure of caregiver competence developed by Kosberg and Cairl. (Kosberg \& Cairl, 1991; Huang \& Shyu, 2003)
    2. This scale is used to assess the caregiver's ability to perform care tasks.
    3. Each item is scored from 1 to 5. Scores can range from 20 to 100, with higher scores representing the ability better.
    4. This scale is used to evaluate family caregivers.

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

  11. 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 evaluate family caregivers.

    Measured: The investigators will evaluate before the intervention, and after intervention for 1, 3, and 6 months. Change from Baseline quality of life (SF-36) at 1, 3, and 6 months.

  12. Qualitative interview

    Conduct qualitative interviews with dementia case managers, focusing on the use of information system.

    Measured: The investigators will conduct qualitative interviews before the intervention, and after intervention for 1 month.

Timeline

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

  1. First posted23 Nov 2021
  2. Study start2 Feb 2023
  3. Primary completion16 May 2023
  4. Study completion16 May 2023

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05131789
Sponsor's protocol ID
ZRRPF3L0041
Status last verified
Jan 2024
First submitted
31 Oct 2021
Last updated
9 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huang HL, Chao YP, Kuo CY, Sung YL, Shyu YL, Hsu WC. Development of a Dementia Case Management Information System App: Mixed Methods Study. JMIR Aging. 2024 Sep 23;7:e56549. doi: 10.2196/56549.

    PubMed 39312770

Questions about this trial

What is this clinical trial studying?

A study testing dementia case management information system 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: finished, as of the sponsor's last update on 9 Jan 2024. 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 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 NCT05131789, 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 9 Jan 2024.

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