Back to resultsEstablishment and Application of Dementia Case Management Information System: A Preliminary Study
Primary Purpose
Dementia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
dementia case management information system
Sponsored by
About this trial
This is an interventional health services research trial for Dementia focused on measuring Dementia, Case management, Information system
Eligibility Criteria
Inclusion Criteria:
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 northern Taiwan (including Taipei, New Taipei, Taoyuan, and Hsinchu).
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).
Exclusion Criteria:
- Dementia Case Managers:
No longer working for dementia center, dementia care center, or Community-Based Dementia Care Center in northern Taiwan (including Taipei, New Taipei, Taoyuan, and Hsinchu).
- Dementia family caregivers:
The people with dementia under care live in a long-term care facility or nursing home.
Sites / Locations
- Chang Gung University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Information System Group
Arm Description
The dementia case managers in the control group perform routine case management. The family caregivers in the control group receive routine services.
The dementia case managers in the experiment group use information system to perform case management. The family caregivers in the control group receive case management with an information system.
Outcomes
Primary Outcome Measures
Dementia Care Professional Competency Assessment Scale
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).
This Scale contains nine subscales (74 items), using Likert 5-point Likert scale from 1 to 5. A higher score means better competencies.
This scale is used to evaluate the competence of dementia case managers.
Problem solving, Teamwork Competency Assessment Scale
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).
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.
This scale is used to evaluate the competence of dementia case managers.
Caregiver Preparedness Scale - Professional version
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).
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.
This scale is used to evaluate the competence of dementia case managers.
Basic information of dementia and family caregivers
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.
This scale is used to evaluate family caregivers.
Cohen-Mansfield Agitation Inventory (CMAI)
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.).
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.
This scale is used to evaluate family caregivers.
Agitation Management Self-Efficacy Scale (AMSS)
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)
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.
This scale is used to evaluate family caregivers.
Activities of daily living (ADL)
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.
The ADL refers to activities oriented toward taking care of one's own body.
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.
This scale is used to evaluate family caregivers.
Instrumental Activities of Daily Living (IADL)
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.
The IADL refers to activities oriented toward interacting with the environment and that are often complex-generally optional in nature.
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.
This scale is used to evaluate family caregivers.
Caregiver competence Scale
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)
This scale is used to assess the caregiver's ability to perform care tasks.
Each item is scored from 1 to 5. Scores can range from 20 to 100, with higher scores representing the ability better.
This scale is used to evaluate family caregivers.
Caregiver Preparedness Scale - family caregiver version
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).
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.
This scale is used to evaluate family caregivers.
36-item short-form health survey (SF-36)
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.
The SF-36 measures eight scales, with higher scores representing the greater quality of life.
This scale is used to evaluate family caregivers.
Qualitative interview
Conduct qualitative interviews with dementia case managers, focusing on the use of information system.
Secondary Outcome Measures
Full Information
NCT ID
NCT05131789
First Posted
October 31, 2021
Last Updated
February 6, 2023
Sponsor
Chang Gung Memorial Hospital
Collaborators
Chang Gung University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05131789
Brief Title
Establishment and Application of Dementia Case Management Information System: A Preliminary Study
Official Title
Establishment and Application of Dementia Case Management Information System: A Preliminary Study - Phase 2
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Chang Gung University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Case management, Information system
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The dementia case managers in the control group perform routine case management.
The family caregivers in the control group receive routine services.
Arm Title
Information System Group
Arm Type
Experimental
Arm Description
The dementia case managers in the experiment group use information system to perform case management.
The family caregivers in the control group receive case management with an information system.
Intervention Type
Procedure
Intervention Name(s)
dementia case management information system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dementia Care Professional Competency Assessment Scale
Description
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).
This Scale contains nine subscales (74 items), using Likert 5-point Likert scale from 1 to 5. A higher score means better competencies.
This scale is used to evaluate the competence of dementia case managers.
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.
Title
Problem solving, Teamwork Competency Assessment Scale
Description
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).
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.
This scale is used to evaluate the competence of dementia case managers.
Time Frame
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.
Title
Caregiver Preparedness Scale - Professional version
Description
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).
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.
This scale is used to evaluate the competence of dementia case managers.
Time Frame
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.
Title
Basic information of dementia and family caregivers
Description
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.
This scale is used to evaluate family caregivers.
Time Frame
The investigators will evaluate before the intervention.
Title
Cohen-Mansfield Agitation Inventory (CMAI)
Description
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.).
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.
This scale is used to evaluate family caregivers.
Time Frame
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.
Title
Agitation Management Self-Efficacy Scale (AMSS)
Description
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)
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.
This scale is used to evaluate family caregivers.
Time Frame
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.
Title
Activities of daily living (ADL)
Description
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.
The ADL refers to activities oriented toward taking care of one's own body.
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.
This scale is used to evaluate family caregivers.
Time Frame
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.
Title
Instrumental Activities of Daily Living (IADL)
Description
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.
The IADL refers to activities oriented toward interacting with the environment and that are often complex-generally optional in nature.
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.
This scale is used to evaluate family caregivers.
Time Frame
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.
Title
Caregiver competence Scale
Description
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)
This scale is used to assess the caregiver's ability to perform care tasks.
Each item is scored from 1 to 5. Scores can range from 20 to 100, with higher scores representing the ability better.
This scale is used to evaluate family caregivers.
Time Frame
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.
Title
Caregiver Preparedness Scale - family caregiver version
Description
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).
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.
This scale is used to evaluate family caregivers.
Time Frame
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.
Title
36-item short-form health survey (SF-36)
Description
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.
The SF-36 measures eight scales, with higher scores representing the greater quality of life.
This scale is used to evaluate family caregivers.
Time Frame
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.
Title
Qualitative interview
Description
Conduct qualitative interviews with dementia case managers, focusing on the use of information system.
Time Frame
The investigators will conduct qualitative interviews before the intervention, and after intervention for 1 month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 northern Taiwan (including Taipei, New Taipei, Taoyuan, and Hsinchu).
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).
Exclusion Criteria:
Dementia Case Managers:
No longer working for dementia center, dementia care center, or Community-Based Dementia Care Center in northern Taiwan (including Taipei, New Taipei, Taoyuan, and Hsinchu).
Dementia family caregivers:
The people with dementia under care live in a long-term care facility or nursing home.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huei-Ling Huang, PhD
Phone
+886-3-2118999
Ext
5803
Email
hlhuang@gw.cgust.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huei-Ling Huang, PhD
Organizational Affiliation
Chang Gung University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung University of Science and Technology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huei-Ling Huang, PhD
Phone
+886-3-2118999
Ext
5803
Email
hlhuang@gw.cgust.edu.tw
12. IPD Sharing Statement
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Establishment and Application of Dementia Case Management Information System: A Preliminary Study
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