Smart-Cloth Care System for Dementia
Primary Purpose
Dementia, Senile, Family Members
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
smart-cloth assisted home nursing care
Sponsored by
About this trial
This is an interventional health services research trial for Dementia, Senile
Eligibility Criteria
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
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
- Chang Gung Memorial Hospital, TaiwanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
smart-cloth
routine care
Arm Description
Participants receive smart-cloth assisted home nursing care
This group receive routine care
Outcomes
Primary Outcome Measures
Time UP and Go
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time UP and Go
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time UP and Go
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Barthel Activity of Daily Living Scale
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Barthel Activity of Daily Living Scale
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Barthel Activity of Daily Living Scale
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
IADL self-care ability
dependency in instrumental activities of daily living
IADL self-care ability
dependency in instrumental activities of daily living
IADL self-care ability
dependency in instrumental activities of daily living
cognitive function
Mini-Mental State Examination
cognitive function
Mini-Mental State Examination
cognitive function
Mini-Mental State Examination
Medical Outcome Short Form-36
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Medical Outcome Short Form-36
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Medical Outcome Short Form-36
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Preparedness scale
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Preparedness scale
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Preparedness scale
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Centre for epidemiological Studies Depression Scale
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Centre for epidemiological Studies Depression Scale
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Centre for epidemiological Studies Depression Scale
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
caregiver balance scale
caregiving balance between competing needs, 0-3, higher score indicate more balanced
caregiver balance scale
caregiving balance between competing needs, 0-3, higher score indicate more balanced
caregiver balance scale
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Caregiver Medical Outcome Short Form-36
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Caregiver Medical Outcome Short Form-36
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Caregiver Medical Outcome Short Form-36
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT05063045
First Posted
September 15, 2021
Last Updated
August 28, 2023
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05063045
Brief Title
Smart-Cloth Care System for Dementia
Official Title
Development and Preliminary Effects of Smart Cloth Care System for Persons With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Senile, Family Members
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A quasi-experimental design using experimental and control group but without random assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
smart-cloth
Arm Type
Experimental
Arm Description
Participants receive smart-cloth assisted home nursing care
Arm Title
routine care
Arm Type
No Intervention
Arm Description
This group receive routine care
Intervention Type
Behavioral
Intervention Name(s)
smart-cloth assisted home nursing care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time UP and Go
Description
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time Frame
two months after installation
Title
Time UP and Go
Description
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time Frame
four months after installation
Title
Time UP and Go
Description
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time Frame
six months after installation
Title
Barthel Activity of Daily Living Scale
Description
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Time Frame
two months after installation
Title
Barthel Activity of Daily Living Scale
Description
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Time Frame
four months after installation
Title
Barthel Activity of Daily Living Scale
Description
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Time Frame
six months after installation
Title
IADL self-care ability
Description
dependency in instrumental activities of daily living
Time Frame
two months after installation
Title
IADL self-care ability
Description
dependency in instrumental activities of daily living
Time Frame
four months after installation
Title
IADL self-care ability
Description
dependency in instrumental activities of daily living
Time Frame
six months after installation
Title
cognitive function
Description
Mini-Mental State Examination
Time Frame
two months after installation
Title
cognitive function
Description
Mini-Mental State Examination
Time Frame
four months after installation
Title
cognitive function
Description
Mini-Mental State Examination
Time Frame
six months after installation
Title
Medical Outcome Short Form-36
Description
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Time Frame
two months after installation
Title
Medical Outcome Short Form-36
Description
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Time Frame
four months after installation
Title
Medical Outcome Short Form-36
Description
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Time Frame
six months after installation
Title
Preparedness scale
Description
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Time Frame
two months after installation
Title
Preparedness scale
Description
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Time Frame
four months after installation
Title
Preparedness scale
Description
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Time Frame
six months after installation
Title
Centre for epidemiological Studies Depression Scale
Description
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Time Frame
two months after installation
Title
Centre for epidemiological Studies Depression Scale
Description
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Time Frame
four months after installation
Title
Centre for epidemiological Studies Depression Scale
Description
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Time Frame
six months after installation
Title
caregiver balance scale
Description
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Time Frame
two months after installation
Title
caregiver balance scale
Description
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Time Frame
four months after installation
Title
caregiver balance scale
Description
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Time Frame
six months after installation
Title
Caregiver Medical Outcome Short Form-36
Description
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Time Frame
two months after installation
Title
Caregiver Medical Outcome Short Form-36
Description
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Time Frame
four months after installation
Title
Caregiver Medical Outcome Short Form-36
Description
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Time Frame
six months after installation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yea-Ing L Shyu, PhD
Phone
0978697460
Email
yeaing@mail.cgu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Yea-Ing L Shyu, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Organizational Affiliation
School of Nursing, Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Phone
+886 3 2118811
Ext
5736
Email
yeaing@mail.cgu.edu.tw
Facility Name
Chang Gung Memorial Hospital, Taiwan
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Phone
+886-3-2118800
Ext
5736
Email
yeaing@mail.cgu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35996089
Citation
Sung YL, Huang HL, Lin CC, Kroger T, Hsu WC, Hsu JL, Lin YE, Shyu YL. Experiences of family caregivers of persons living with dementia with and without a smart- clothes assisted home nursing program during the heightened COVID-19 alert. BMC Geriatr. 2022 Aug 23;22(1):697. doi: 10.1186/s12877-022-03379-8.
Results Reference
derived
Learn more about this trial
Smart-Cloth Care System for Dementia
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