NCT05131789

Brief 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. In the second year, the investigators will conduct a pilot study to examine the effectiveness of the case management information system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 31, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

October 31, 2021

Last Update Submit

January 5, 2024

Conditions

Keywords

DementiaCase managementInformation system

Outcome Measures

Primary Outcomes (12)

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    The investigators will evaluate before the intervention.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • 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.

    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.

  • Qualitative interview

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

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

Study Arms (1)

Information System Group

EXPERIMENTAL

The dementia case managers in the experiment group use information system to perform case management.

Procedure: dementia case management information system

Interventions

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.

Information System Group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University of Science and Technology

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Huei-Ling Huang, PhD

    Chang Gung University of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD, RN, Department of Gerontology and Health Care Management, College of Nursing, Chang Gung University of Science and Technology, Taoyuan, Taiwan, R.O.C

Study Record Dates

First Submitted

October 31, 2021

First Posted

November 23, 2021

Study Start

February 2, 2023

Primary Completion

May 16, 2023

Study Completion

May 16, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations