An interventional study of smart-cloth assisted home nursing in Dementia and Family, sponsored by Chang Gung Memorial Hospital. Completed at 2 sites in Taiwan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Health services research
The purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver App, and to examine its effect on a randomized controlled trial.
The purposes of this study are to develop an upgraded version of the smart-clothes home care model that include an interactive family caregiver App, and to examine its effect on a randomized controlled trial. This 3-year study will spend the first 6 months to developed the upgraded smart-clothes home care model, and the later 2 and a half years on the clinical trial and follow-ups. In addition to the original function of abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks, this upgraded version will include monitoring for medication, abnormal life pattern, quality of hired help. The warning signals, along with weekly summary and related information will be sent to the family caregiver interactive App after the assessment of the home care nurses to provide guidance for family care.
During the first 6 months, the upgraded smart-clothes home care model will be developed according to qualitative and quantitative data of the prior study and expert reviews. For the clinical trial in later 2 1/2 years, a total of 60 participant families will be randomly assigned to experimental (N=30) and control (N=30) group, with experimental group receiving the upgraded smart-clothes home care for 6 months and control group received routine care with 6 month follow-ups. Outcomes including caregiver preparedness, balance between competing needs, health related quality of life and depressive symptoms, and fall, time up \& go, activities of daily living (ADLs), instrumental ADLs, cognitive function and quality of life of the patient will be followed every 2 month for 6 months. Intention-to-treat and hierarchical linear models will be used to analyze the results.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The upgraded smart-cloth assisted home nursing integrate smart-cloth monitoring system, home nursing, and family caregiver feedback app. The persons living with dementia will be asked to wear a smart cloth 24 hours a day and will be monitored on abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks. In addition, monitoring for medication, abnormal life pattern, quality of hired help will also be included. The warning signals, along with weekly summary and related information will be sent to the family caregiver interactive App after the assessment of the home care nurses to provide guidance for family care.
Behavioral: smart-cloth assisted home nursing
Routine clinical care will be provided to the participants.
The upgraded smart-cloth assisted home nursing integrate smart-cloth monitoring system, home nursing, and family caregiver feedback app. The persons living with dementia will be asked to wear a smart cloth 24 hours a day and will be monitored on abnormal activity level, going out alone, abnormal number of getting-up at night, fall risks. In addition, monitoring for medication, abnormal life pattern, quality of hired help will also be included. The warning signals, along with weekly summary and related information will be sent to the family caregiver interactive App after the assessment of the home care nurses to provide guidance for family care.
caregiver preparedness
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
Time frame: baseline
caregiver preparedness
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
Time frame: 2 months after baseline
caregiver preparedness
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
Time frame: 4 months after baseline
caregiver preparedness
Preparedness is measured by self-report with an 8-item scale. This scale asks caregivers to rate how well-prepared they think they are for seven domains of caregiving.
Time frame: 6 months after baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time frame: baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 2 months after baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 4 months after baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time frame: 6 months after baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Time frame: Baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Time frame: 2 month after Baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Time frame: 4 month after Baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Time frame: 6 month after Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Time frame: Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Time frame: 2 month after Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Time frame: 4 month after Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Time frame: 6 month after Baseline
Time Up and Go test
assessing fall risk for the persons living with dementia
Time frame: baseline
Time Up and Go test
assessing fall risk for the persons living with dementia
Time frame: 2 month after baseline
Time Up and Go test
assessing fall risk for the persons living with dementia
Time frame: 4 month after baseline
Time Up and Go test
assessing fall risk for the persons living with dementia (PLWD)
Time frame: 6 month after baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Time frame: baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Time frame: 2 months after baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Time frame: 4 months after baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Time frame: 6 months after baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Time frame: baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Time frame: 2 months after baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Time frame: 4 months after baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Time frame: 6 months after baseline
Cognitive function
Mini-Mental State Examination
Time frame: baseline
Cognitive function
Mini-Mental State Examination
Time frame: 2 month after baseline
Cognitive function
Mini-Mental State Examination
Time frame: 4 month after baseline
Cognitive function
Mini-Mental State Examination
Time frame: 6 month after baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Time frame: baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Time frame: 2 month after baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Time frame: 4 month after baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Time frame: 6 month after baseline
Plan to share: No
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Chang Gung Memorial Hospital