Upgraded Smart Cloth Home Care System for Persons With Dementia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Clinical Trial on an Upgraded Smart Cloth Home Care System With Interactive Family Caregiver App for Persons With Dementia

Conditions
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Dementia, Family

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as having dementia can walk independently or with help able to communicate living in Northern Taiwan. Family caregiver age 20 or older taking primary responsibility in providing family care. Exclusion Criteria: with terminal illness with severe diseases that can not be controlled.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Current study plan to developed an advanced version of this smart-clothes care model based on prior study and the theory of Finding a Balance Point to further include monitoring for medication, abnormal life patter of the persons with dementia, and quality of hired care, and an interactive family caregiver app, and to examine this upgraded smart-clothes care system in a clinical trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: smart-cloth<br>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<br>* 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.<br>|
| No Intervention: usual care<br>Routine clinical care will be provided to the participants. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caregiver preparedness | 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. | baseline | 
| caregiver preparedness | 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. | 2 months after baseline | 
| caregiver preparedness | 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. | 4 months after baseline | 
| caregiver preparedness | 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. | 6 months after baseline | 
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) | baseline | 
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) | 2 months after baseline | 
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) | 4 months after baseline | 
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) | 6 months after baseline | 
| Caregiving Balance | The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002). | Baseline | 
| Caregiving Balance | The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002). | 2 month after Baseline | 
| Caregiving Balance | The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002). | 4 month after Baseline | 
| Caregiving Balance | The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002). | 6 month after Baseline | 
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | Baseline | 
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | 2 month after Baseline | 
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | 4 month after Baseline | 
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | 6 month after Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Up and Go test | assessing fall risk for the persons living with dementia | baseline | 
| Time Up and Go test | assessing fall risk for the persons living with dementia | 2 month after baseline | 
| Time Up and Go test | assessing fall risk for the persons living with dementia | 4 month after baseline | 
| Time Up and Go test | assessing fall risk for the persons living with dementia (PLWD) | 6 month after baseline | 
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | baseline | 
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | 2 months after baseline | 
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | 4 months after baseline | 
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | 6 months after baseline | 
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | baseline | 
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | 2 months after baseline | 
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | 4 months after baseline | 
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | 6 months after baseline | 
| Cognitive function | Mini-Mental State Examination | baseline | 
| Cognitive function | Mini-Mental State Examination | 2 month after baseline | 
| Cognitive function | Mini-Mental State Examination | 4 month after baseline | 
| Cognitive function | Mini-Mental State Examination | 6 month after baseline | 
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | baseline | 
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | 2 month after baseline | 
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | 4 month after baseline | 
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | 6 month after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, family caregiver, smart care, home nursing