Clinical trial NCT05063045: Smart-Cloth Care System for Dementia
Official title: Development and Preliminary Effects of Smart Cloth Care System for Persons With Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia, Senile
Family Members
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A quasi-experimental design using experimental and control group but without random assignment
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Time UP and Go
timeFrame: two months after installation
measure: Time UP and Go
timeFrame: four months after installation
measure: Time UP and Go
timeFrame: six months after installation
measure: Barthel Activity of Daily Living Scale
timeFrame: two months after installation
measure: Barthel Activity of Daily Living Scale
timeFrame: four months after installation
measure: Barthel Activity of Daily Living Scale
timeFrame: six months after installation
measure: IADL self-care ability
timeFrame: two months after installation
measure: IADL self-care ability
timeFrame: four months after installation
measure: IADL self-care ability
timeFrame: six months after installation
measure: cognitive function
timeFrame: two months after installation
measure: cognitive function
timeFrame: four months after installation
measure: cognitive function
timeFrame: six months after installation
measure: Medical Outcome Short Form-36
timeFrame: two months after installation
measure: Medical Outcome Short Form-36
timeFrame: four months after installation
measure: Medical Outcome Short Form-36
timeFrame: six months after installation
measure: Preparedness scale
timeFrame: two months after installation
measure: Preparedness scale
timeFrame: four months after installation
measure: Preparedness scale
timeFrame: six months after installation
measure: Centre for epidemiological Studies Depression Scale
timeFrame: two months after installation
measure: Centre for epidemiological Studies Depression Scale
timeFrame: four months after installation
measure: Centre for epidemiological Studies Depression Scale
timeFrame: six months after installation
measure: caregiver balance scale
timeFrame: two months after installation
measure: caregiver balance scale
timeFrame: four months after installation
measure: caregiver balance scale
timeFrame: six months after installation
measure: Caregiver Medical Outcome Short Form-36
timeFrame: two months after installation
measure: Caregiver Medical Outcome Short Form-36
timeFrame: four months after installation
measure: Caregiver Medical Outcome Short Form-36
timeFrame: six months after installation
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Taiwan
Study officials:
affiliation: School of Nursing, Chang Gung University
name: Yea-Ing L Shyu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.