Smart-Cloth Care System for Dementia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Family Members; Dementia, Senile
• Intervention / Treatment: Behavioral: smart-cloth assisted home nursing care

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yea-Ing L Shyu, PhD; Phone Number: 0978697460; Email: yeaing@mail.cgu.edu.tw
• Study Contact Backup: Name: Yea-Ing L Shyu, PhD

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Chang Gung memorial hospital
    • Contact: Yea-Ing L Shyu, PhD; Phone Number: 5736 +886 3 2118811; Email: yeaing@mail.cgu.edu.tw
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital, Taiwan
    • Contact: Yea-Ing L Shyu, PhD; Phone Number: 5736 +886-3-2118800; Email: yeaing@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smart-cloth; Participants receive smart-cloth assisted home nursing care	Behavioral: smart-cloth assisted home nursing care; 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.
No Intervention: routine care; This group receive routine care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yea-Ing L Shyu, PhD, School of Nursing, Chang Gung University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: MOST 107-2314-B-182-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No