Smart-Cloth Care System for Dementia

Family Members Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063045
• Other study ID #: MOST 107-2314-B-182-007
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: Yea-Ing L Shyu, PhD
• Phone: 0978697460
• Email: yeaing[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Family Members

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, Taiwan	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	IADL self-care ability	dependency in instrumental activities of daily living	two months after installation
Primary	IADL self-care ability	dependency in instrumental activities of daily living	four months after installation
Primary	IADL self-care ability	dependency in instrumental activities of daily living	six months after installation
Primary	cognitive function	Mini-Mental State Examination	two months after installation
Primary	cognitive function	Mini-Mental State Examination	four months after installation
Primary	cognitive function	Mini-Mental State Examination	six months after installation
Primary	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
Primary	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
Primary	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
Primary	Preparedness scale	caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness	two months after installation
Primary	Preparedness scale	caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness	four months after installation
Primary	Preparedness scale	caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness	six months after installation
Primary	Centre for epidemiological Studies Depression Scale	caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms	two months after installation
Primary	Centre for epidemiological Studies Depression Scale	caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms	four months after installation
Primary	Centre for epidemiological Studies Depression Scale	caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms	six months after installation
Primary	caregiver balance scale	caregiving balance between competing needs, 0-3, higher score indicate more balanced	two months after installation
Primary	caregiver balance scale	caregiving balance between competing needs, 0-3, higher score indicate more balanced	four months after installation
Primary	caregiver balance scale	caregiving balance between competing needs, 0-3, higher score indicate more balanced	six months after installation
Primary	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
Primary	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
Primary	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