Upgraded Smart Cloth Home Care System for Persons With Dementia

A Clinical Trial on an Upgraded Smart Cloth Home Care System With Interactive Family Caregiver App for Persons With Dementia

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Family
• Intervention / Treatment: Behavioral: smart-cloth assisted home nursing

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 236017
    • New Taipei Tucheng hospital
  • Taoyuan District, Taiwan
    • Chang Gung Memorial Hospital, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed as having dementia
• can walk independently or with help
• able to communicate
• living in Northern Taiwan.
• Family caregiver age 20 or older
• taking primary responsibility in providing family care.

Exclusion Criteria:

• with terminal illness
• with severe diseases that can not be controlled.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: smart-cloth; 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; 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.
No Intervention: usual care; Routine clinical care will be provided to the participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 months after baseline
caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	baseline
caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	2 months after baseline
caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	4 months after baseline
caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	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).	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).	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).	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).	6 month after Baseline
Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	Baseline
Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	2 month after Baseline
Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	4 month after Baseline
Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	6 month after Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Up and Go test	assessing fall risk for the persons living with dementia	baseline
Time Up and Go test	assessing fall risk for the persons living with dementia	2 month after baseline
Time Up and Go test	assessing fall risk for the persons living with dementia	4 month after baseline
Time Up and Go test	assessing fall risk for the persons living with dementia (PLWD)	6 month after baseline
Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	baseline
Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	2 months after baseline
Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	4 months after baseline
Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	6 months after baseline
Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	baseline
Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	2 months after baseline
Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	4 months after baseline
Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	6 months after baseline
Cognitive function	Mini-Mental State Examination	baseline
Cognitive function	Mini-Mental State Examination	2 month after baseline
Cognitive function	Mini-Mental State Examination	4 month after baseline
Cognitive function	Mini-Mental State Examination	6 month after baseline
Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	baseline
Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	2 month after baseline
Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	4 month after baseline
Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	6 month after baseline

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yea-Ing L Shyu, PhD, Professor

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: dementia; family caregiver; smart care; home nursing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 111-2314-B-182 -010 -MY3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No