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Smart-Cloth Care System for Dementia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05063045
Enrollment
60
Registered
2021-09-30
Start date
2020-08-01
Completion date
2023-11-30
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Senile, Family Members

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.

Interventions

BEHAVIORALsmart-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.

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

A quasi-experimental design using experimental and control group but without random assignment

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time UP and Gotwo months after installationTime spends while stand from an armed chair, walk for three meters and come back to sit down
Barthel Activity of Daily Living Scaletwo months after installationdependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
IADL self-care abilitytwo months after installationdependency in instrumental activities of daily living
cognitive functiontwo months after installationMini-Mental State Examination
Medical Outcome Short Form-36two months after installationHealth-related quality of life, from 0-100, higher score representing better health related quality of life
Preparedness scaletwo months after installationcaregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Centre for epidemiological Studies Depression Scaletwo months after installationcaregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
caregiver balance scaletwo months after installationcaregiving balance between competing needs, 0-3, higher score indicate more balanced
Caregiver Medical Outcome Short Form-36two months after installationcaregiver health-related quality of life, from 0-100, higher score representing better health related quality of life

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026