NCT Number: NCT05063045
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.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Chang Gung Memorial Hospital, Taipei, Taiwan
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
Terminal ill Living in institution
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.
Time frame: two months after installation
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time frame: four months after installation
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time frame: six months after installation
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time frame: two months after installation
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Time frame: four months after installation
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Time frame: six months after installation
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Time frame: two months after installation
dependency in instrumental activities of daily living
Time frame: four months after installation
dependency in instrumental activities of daily living
Time frame: six months after installation
dependency in instrumental activities of daily living
Time frame: two months after installation
Mini-Mental State Examination
Time frame: four months after installation
Mini-Mental State Examination
Time frame: six months after installation
Mini-Mental State Examination
Time frame: two months after installation
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Time frame: four months after installation
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Time frame: six months after installation
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Time frame: two months after installation
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Time frame: four months after installation
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Time frame: six months after installation
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Time frame: two months after installation
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Time frame: four months after installation
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Time frame: six months after installation
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Time frame: two months after installation
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Time frame: four months after installation
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Time frame: six months after installation
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Time frame: two months after installation
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Time frame: four months after installation
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Time frame: six months after installation
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Chang Gung Memorial Hospital
Other
Development and Preliminary Effects of Smart Cloth Care System for Persons With Dementia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04627662
Alzheimer Disease, Behavior
Portland, Oregon, United States
View Trial DetailsNCT04335110
Alzheimer Disease, Behavior
Portland, Oregon, United States
View Trial DetailsNCT05776641
Alzheimer Disease, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT05929703
Aging, Alzheimer Disease
Orange, California, United States
View Trial Details