Smart-Cloth Care System for Dementia

Not Applicable

Recruiting

• Conditions: Family Members; Dementia, Senile

• Registration Number: NCT05063045
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (2)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital, Taiwan; 🇨🇳 Taoyuan, Taiwan