Upgraded Smart Cloth Home Care System for Persons With Dementia
Study Details
Study Description
Brief Summary
The purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver App, and to examine its effect on a randomized controlled trial.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver App, and to examine its effect on a randomized controlled trial. This 3-year study will spend the first 6 months to developed the upgraded smart-clothes home care model, and the later 2 and a half years on the clinical trial and follow-ups. In addition to the original function of abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks, this upgraded version will include monitoring for medication, abnormal life pattern, quality of hired help. The warning signals, along with weekly summary and related information will be sent to the family caregiver interactive App after the assessment of the home care nurses to provide guidance for family care.
During the first 6 months, the upgraded smart-clothes home care model will be developed according to qualitative and quantitative data of the prior study and expert reviews. For the clinical trial in later 2 1/2 years, a total of 60 participant families will be randomly assigned to experimental (N=30) and control (N=30) group, with experimental group receiving the upgraded smart-clothes home care for 6 months and control group received routine care with 6 month follow-ups. Outcomes including caregiver preparedness, balance between competing needs, health related quality of life and depressive symptoms, and fall, time up & go, activities of daily living (ADLs), instrumental ADLs, cognitive function and quality of life of the patient will be followed every 2 month for 6 months. Intention-to-treat and hierarchical linear models will be used to analyze the results.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: smart-cloth The upgraded smart-cloth assisted home nursing integrate smart-cloth monitoring system, home nursing, and family caregiver feedback app. The persons living with dementia will be asked to wear a smart cloth 24 hours a day and will be monitored on abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks. In addition, monitoring for medication, abnormal life pattern, quality of hired help will also be included. The warning signals, along with weekly summary and related information will be sent to the family caregiver interactive App after the assessment of the home care nurses to provide guidance for family care. |
Behavioral: smart-cloth assisted home nursing
The upgraded smart-cloth assisted home nursing integrate smart-cloth monitoring system, home nursing, and family caregiver feedback app. The persons living with dementia will be asked to wear a smart cloth 24 hours a day and will be monitored on abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks. In addition, monitoring for medication, abnormal life pattern, quality of hired help will also be included. The warning signals, along with weekly summary and related information will be sent to the family caregiver interactive App after the assessment of the home care nurses to provide guidance for family care.
|
| No Intervention: usual care Routine clinical care will be provided to the participants. |
Outcome Measures
Primary Outcome Measures
- caregiver preparedness [baseline]
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
- caregiver preparedness [2 months after baseline]
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
- caregiver preparedness [4 months after baseline]
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
- caregiver preparedness [6 months after baseline]
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
- caregiver depressive symptoms [baseline]
Centre for Epidemiologic Studies Depression Scale (CES-D)
- caregiver depressive symptoms [2 months after baseline]
Centre for Epidemiologic Studies Depression Scale (CES-D)
- caregiver depressive symptoms [4 months after baseline]
Centre for Epidemiologic Studies Depression Scale (CES-D)
- caregiver depressive symptoms [6 months after baseline]
Centre for Epidemiologic Studies Depression Scale (CES-D)
- Caregiving Balance [Baseline]
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
- Caregiving Balance [2 month after Baseline]
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
- Caregiving Balance [4 month after Baseline]
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
- Caregiving Balance [6 month after Baseline]
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
- Caregiving Health Related Quality of Life [Baseline]
Medical Outcome SF-36 Taiwan version
- Caregiving Health Related Quality of Life [2 month after Baseline]
Medical Outcome SF-36 Taiwan version
- Caregiving Health Related Quality of Life [4 month after Baseline]
Medical Outcome SF-36 Taiwan version
- Caregiving Health Related Quality of Life [6 month after Baseline]
Medical Outcome SF-36 Taiwan version
Secondary Outcome Measures
- Time Up and Go test [baseline]
assessing fall risk for the persons living with dementia
- Time Up and Go test [2 month after baseline]
assessing fall risk for the persons living with dementia
- Time Up and Go test [4 month after baseline]
assessing fall risk for the persons living with dementia
- Time Up and Go test [6 month after baseline]
assessing fall risk for the persons living with dementia (PLWD)
- Activities of Daily Living (ADL) [baseline]
Chinese Barthel Index leasing independence in ADL for PLWD
- Activities of Daily Living (ADL) [2 months after baseline]
Chinese Barthel Index leasing independence in ADL for PLWD
- Activities of Daily Living (ADL) [4 months after baseline]
Chinese Barthel Index leasing independence in ADL for PLWD
- Activities of Daily Living (ADL) [6 months after baseline]
Chinese Barthel Index leasing independence in ADL for PLWD
- Instrumental activities of daily living (IADL) [baseline]
Lawton and Brody's IADL measure
- Instrumental activities of daily living (IADL) [2 months after baseline]
Lawton and Brody's IADL measure
- Instrumental activities of daily living (IADL) [4 months after baseline]
Lawton and Brody's IADL measure
- Instrumental activities of daily living (IADL) [6 months after baseline]
Lawton and Brody's IADL measure
- Cognitive function [baseline]
Mini-Mental State Examination
- Cognitive function [2 month after baseline]
Mini-Mental State Examination
- Cognitive function [4 month after baseline]
Mini-Mental State Examination
- Cognitive function [6 month after baseline]
Mini-Mental State Examination
- Health related quality of life for PLWD [baseline]
Medical Outcomes SF-36 Taiwan Version
- Health related quality of life for PLWD [2 month after baseline]
Medical Outcomes SF-36 Taiwan Version
- Health related quality of life for PLWD [4 month after baseline]
Medical Outcomes SF-36 Taiwan Version
- Health related quality of life for PLWD [6 month after baseline]
Medical Outcomes SF-36 Taiwan Version
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed as having dementia
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can walk independently or with help
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able to communicate
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living in Northern Taiwan.
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Family caregiver age 20 or older
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taking primary responsibility in providing family care.
Exclusion Criteria:
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with terminal illness
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with severe diseases that can not be controlled.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New Taipei Tucheng hospital | New Taipei City | Taiwan | 236017 | |
| 2 | Chang Gung Memorial Hospital, Taiwan | Taoyuan | Taiwan |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Principal Investigator: Yea-Ing L Shyu, PhD, Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 111-2314-B-182 -010 -MY3