Smart-Cloth Care System for Dementia

Study Overview
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Brief Summary
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The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. This will be a three-year study, with the first two years to explore the feasibility of such a smart cloth care system and the third year to pilot test its effects. During the third year, a quasi experimental design will be implemented and the outcomes of caregivers and persons with dementia will be followed for 6 months.

Detailed Description
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The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. A smart-care model, using smart clothing with a remote monitoring system, was developed to assist home-nursing care. Older persons with dementia are asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors are installed in bedrooms and living areas to receive signals from the smart clothing. Alarm at door, emergency button and smoke detector are also installed. The signals and emergency information are transmitted to the mobile phones of responsible home care nurses, who have downloaded an app to their phones. After the home care nurse receive a sensor signal, she would then give feedback to family caregivers about the care receiver, including emergency calls, frequent getting up at night, staying in the bathroom for more than 30 minutes, inadequate or abnormal activity level, not moving during the day for more than 2 hours, leaving the house alone, and a sensor being disconnected from the system. Based on information and signals from smart-care sensors, home care nurses will discuss caregiving activities and planning with family caregivers.Participants were asked to wear smart clothing for at least 4 days/week for 6 months. A home care research nurse will visit the home setting to assess it for sensor installation and suggest environmental modifications for potential hazards. A second visit will be made by an engineer with the research nurse to install the sensors. The research nurse visit the participants' homes once a week during the first month and once every month from the second to third month after the sensor installation to conduct in-home interventions and resolve problems using the smart-care system. During the first two years, this smart cloth care system will be developed. During the third year. The investigators plan to recruit at least 60 participants and randomize them into an intervention group (N=30) that receives the smart cloth care model and a control group (N=30) that receives usual care. Patient and caregiver outcomes will be followed every two months for a period of 6 months after the smart cloth care system has been implemented. Finally Intention-to-treat and hierarchical linear models will be used to analyze the results.

Official Title
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Development and Preliminary Effects of Smart Cloth Care System for Persons With Dementia

Conditions
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Dementia, Senile, Family Members

Intervention / Treatment
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* Behavioral: smart-cloth assisted home nursing care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older persons were included by these criteria: age 60 or older diagnosed with dementia, or received surgery for a hip fracture could walk independently or with assistance living with family members in northern Taiwan. Family caregivers were included by these criteria: 20 years old responsible for providing direct care or supervising care received by the patient. Exclusion Criteria: Terminal ill Living in institution

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A quasi-experimental design using experimental and control group but without random assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smart-cloth<br>Participants receive smart-cloth assisted home nursing care | Behavioral: smart-cloth assisted home nursing care<br>* Older persons with dementia or hip fracture were asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors were installed in bedrooms and living areas to receive signals from the smart clothing. The home care nurses then gave feedback from the sensor signals to family caregivers.<br>|
| No Intervention: routine care<br>This group receive routine care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time UP and Go | Time spends while stand from an armed chair, walk for three meters and come back to sit down | two months after installation | 
| Time UP and Go | Time spends while stand from an armed chair, walk for three meters and come back to sit down | four months after installation | 
| Time UP and Go | Time spends while stand from an armed chair, walk for three meters and come back to sit down | six months after installation | 
| Barthel Activity of Daily Living Scale | dependency in activities of daily living, 0-100, higher score indicate better activities of daily living. | two months after installation | 
| Barthel Activity of Daily Living Scale | dependency in activities of daily living, 0-100, higher score indicate better activities of daily living. | four months after installation | 
| Barthel Activity of Daily Living Scale | dependency in activities of daily living, 0-100, higher score indicate better activities of daily living. | six months after installation | 
| IADL self-care ability | dependency in instrumental activities of daily living | two months after installation | 
| IADL self-care ability | dependency in instrumental activities of daily living | four months after installation | 
| IADL self-care ability | dependency in instrumental activities of daily living | six months after installation | 
| cognitive function | Mini-Mental State Examination | two months after installation | 
| cognitive function | Mini-Mental State Examination | four months after installation | 
| cognitive function | Mini-Mental State Examination | six months after installation | 
| Medical Outcome Short Form-36 | Health-related quality of life, from 0-100, higher score representing better health related quality of life | two months after installation | 
| Medical Outcome Short Form-36 | Health-related quality of life, from 0-100, higher score representing better health related quality of life | four months after installation | 
| Medical Outcome Short Form-36 | Health-related quality of life, from 0-100, higher score representing better health related quality of life | six months after installation | 
| Preparedness scale | caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness | two months after installation | 
| Preparedness scale | caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness | four months after installation | 
| Preparedness scale | caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness | six months after installation | 
| Centre for epidemiological Studies Depression Scale | caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms | two months after installation | 
| Centre for epidemiological Studies Depression Scale | caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms | four months after installation | 
| Centre for epidemiological Studies Depression Scale | caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms | six months after installation | 
| caregiver balance scale | caregiving balance between competing needs, 0-3, higher score indicate more balanced | two months after installation | 
| caregiver balance scale | caregiving balance between competing needs, 0-3, higher score indicate more balanced | four months after installation | 
| caregiver balance scale | caregiving balance between competing needs, 0-3, higher score indicate more balanced | six months after installation | 
| Caregiver Medical Outcome Short Form-36 | caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life | two months after installation | 
| Caregiver Medical Outcome Short Form-36 | caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life | four months after installation | 
| Caregiver Medical Outcome Short Form-36 | caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life | six months after installation |