Upgraded Smart Cloth Home Care System for Persons With Dementia

NCT05476809 | Completed DMC

• 1 other identifier: 111-2314-B-182 -010 -MY3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Dementia; Family

Keywords

dementia; family caregiver; smart care; home nursing

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (20)

• Time Up and Go test

  baseline

• Time Up and Go test

  2 month after baseline

• Time Up and Go test

  4 month after baseline

• Time Up and Go test

  6 month after baseline

• Activities of Daily Living (ADL)

  baseline

Study Arms (2)

smart-cloth

EXPERIMENTAL

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

usual care

NO INTERVENTION

Routine clinical care will be provided to the participants.

Interventions

smart-cloth assisted home nursing BEHAVIORAL

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.

smart-cloth

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

New Taipei Tucheng hospital

New Taipei City, 236017, Taiwan

Location

Chang Gung Memorial Hospital, Taiwan

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yea-Ing L Shyu, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization to groups will follow a randomization table created by our university statistician. The project manager will create sequentially numbered sealed envelopes containing group assignment. Each consenting patient and their family caregiver will receive the envelope in the order in which they are enrolled. The project manager will have access to the spreadsheet that indicates the randomization order, but not the research nurses who assess outcomes. After randomization, patients and their family caregivers in the experimental group will receive the SCM, and those in the control group will receive usual care. Patients and families will not be aware of their group enrollment and will be masked to the care model they receive. Research nurses who collect data will be independent of those who deliver the interventions.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Current study plan to developed an advanced version of this smart-clothes care model based on prior study and the theory of Finding a Balance Point to further include monitoring for medication, abnormal life patter of the persons with dementia, and quality of hired care, and an interactive family caregiver app, and to examine this upgraded smart-clothes care system in a clinical trial.

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 27, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)