Dementia Clinical Trial
Official title:
Establishment and Application of Dementia Case Management Information System: A Preliminary Study - Phase 2
Verified date | January 2024 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 16, 2023 |
Est. primary completion date | May 16, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Dementia Case Managers: 1. Be at least 20 years old and could communicate in Chinese or Taiwanese. 2. Currently work for dementia center, dementia care center, or Community-Based Dementia Care Center in Taiwan. - Dementia family caregivers: 1. Be at least 20 years old and could communicate in Chinese or Taiwanese. 2. Primary caregivers 3. The people with dementia under care are diagnosed with dementia Clinical Dementia Rating(CDR) 0.5 or higher. 4. 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 Taiwan. - Dementia family caregivers: The people with dementia under care live in a long-term care facility or nursing home. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung University of Science and Technology | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | Chang Gung University of Science and Technology |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
The investigators will evaluate before the intervention. | |
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
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. | |
Primary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05686486 -
Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes
|
N/A | |
Terminated |
NCT05451693 -
Outreach-ER: A Dementia Care Intervention Program
|
||
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Enrolling by invitation |
NCT06040294 -
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
|
N/A | |
Completed |
NCT05114187 -
An Internet-Based Education Program for Care Partners of People Living With Dementia
|
N/A | |
Recruiting |
NCT06322121 -
Vascular Aspects in Dementia: Part 2
|
||
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT04426838 -
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
|
N/A | |
Recruiting |
NCT03462485 -
Pilot Study of the Effects of Playing Golf on People With Dementia
|
N/A | |
Active, not recruiting |
NCT03677284 -
Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia
|
N/A | |
Completed |
NCT03849937 -
Changing Talk Online (CHATO) Study
|
N/A | |
Recruiting |
NCT06284213 -
Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
|
||
Recruiting |
NCT05579236 -
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
|
||
Completed |
NCT05080777 -
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
|
N/A | |
Completed |
NCT04571697 -
A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
|
||
Completed |
NCT03583879 -
Using Gait Robotics to Improve Symptoms of Parkinson's Disease
|
N/A | |
Recruiting |
NCT06033066 -
Financial Incentives and Recruitment to the APT Webstudy
|
N/A | |
Active, not recruiting |
NCT05204940 -
Longitudinal Observational Biomarker Study
|
||
Recruiting |
NCT05684783 -
Dementia Champions in Homecare
|
||
Completed |
NCT03147222 -
Function Focused Care: Fracture Care at Home
|
N/A |