NCT05063045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 30, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

November 21, 2025

Status Verified

October 1, 2025

Enrollment Period

3.3 years

First QC Date

September 15, 2021

Last Update Submit

November 18, 2025

Conditions

Dementia, SenileFamily Members

Outcome Measures

Primary Outcomes (27)

  • Time UP and Go

    Time spends while stand from an armed chair, walk for three meters and come back to sit down

    two months after installation

  • Time UP and Go

    Time spends while stand from an armed chair, walk for three meters and come back to sit down

    four months after installation

  • Time UP and Go

    Time spends while stand from an armed chair, walk for three meters and come back to sit down

    six months after installation

  • Barthel Activity of Daily Living Scale

    dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.

    two months after installation

  • Barthel Activity of Daily Living Scale

    dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.

    four months after installation

  • Barthel Activity of Daily Living Scale

    dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.

    six months after installation

  • IADL self-care ability

    dependency in instrumental activities of daily living

    two months after installation

  • IADL self-care ability

    dependency in instrumental activities of daily living

    four months after installation

  • IADL self-care ability

    dependency in instrumental activities of daily living

    six months after installation

  • cognitive function

    Mini-Mental State Examination

    two months after installation

  • cognitive function

    Mini-Mental State Examination

    four months after installation

  • cognitive function

    Mini-Mental State Examination

    six months after installation

  • Medical Outcome Short Form-36

    Health-related quality of life, from 0-100, higher score representing better health related quality of life

    two months after installation

  • Medical Outcome Short Form-36

    Health-related quality of life, from 0-100, higher score representing better health related quality of life

    four months after installation

  • Medical Outcome Short Form-36

    Health-related quality of life, from 0-100, higher score representing better health related quality of life

    six months after installation

  • Preparedness scale

    caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness

    two months after installation

  • Preparedness scale

    caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness

    four months after installation

  • Preparedness scale

    caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness

    six months after installation

  • Centre for epidemiological Studies Depression Scale

    caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms

    two months after installation

  • Centre for epidemiological Studies Depression Scale

    caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms

    four months after installation

  • Centre for epidemiological Studies Depression Scale

    caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms

    six months after installation

  • caregiver balance scale

    caregiving balance between competing needs, 0-3, higher score indicate more balanced

    two months after installation

  • caregiver balance scale

    caregiving balance between competing needs, 0-3, higher score indicate more balanced

    four months after installation

  • caregiver balance scale

    caregiving balance between competing needs, 0-3, higher score indicate more balanced

    six months after installation

  • Caregiver Medical Outcome Short Form-36

    caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life

    two months after installation

  • Caregiver Medical Outcome Short Form-36

    caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life

    four months after installation

  • Caregiver Medical Outcome Short Form-36

    caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life

    six months after installation

Study Arms (2)

smart-cloth

EXPERIMENTAL

Participants receive smart-cloth assisted home nursing care

Behavioral: smart-cloth assisted home nursing care

routine care

NO INTERVENTION

This group receive routine care

Interventions

smart-cloth assisted home nursing careBEHAVIORAL

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.

smart-cloth

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • years old responsible for providing direct care or supervising care received by the patient.

You may not qualify if:

  • Terminal ill Living in institution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chang Gung Memorial Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital, Taiwan

Taoyuan District, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 35996089DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Yea-Ing L Shyu, PhD

    School of Nursing, Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A quasi-experimental design using experimental and control group but without random assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2021

First Posted

September 30, 2021

Study Start

August 1, 2020

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

November 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)