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Completed

NCT Number: NCT05476809

Upgraded Smart Cloth Home Care System 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New Taipei Tucheng hospital, New Taipei City, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. caregiver preparedness

    Time frame: baseline

    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. caregiver preparedness

    Time frame: 2 months after baseline

    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.

  3. caregiver preparedness

    Time frame: 4 months after baseline

    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. caregiver preparedness

    Time frame: 6 months after baseline

    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.

  5. caregiver depressive symptoms

    Time frame: baseline

    Centre for Epidemiologic Studies Depression Scale (CES-D)

  6. caregiver depressive symptoms

    Time frame: 2 months after baseline

    Centre for Epidemiologic Studies Depression Scale (CES-D)

  7. caregiver depressive symptoms

    Time frame: 4 months after baseline

    Centre for Epidemiologic Studies Depression Scale (CES-D)

  8. caregiver depressive symptoms

    Time frame: 6 months after baseline

    Centre for Epidemiologic Studies Depression Scale (CES-D)

  9. Caregiving Balance

    Time frame: Baseline

    The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).

  10. Caregiving Balance

    Time frame: 2 month after Baseline

    The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).

  11. Caregiving Balance

    Time frame: 4 month after Baseline

    The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).

  12. Caregiving Balance

    Time frame: 6 month after Baseline

    The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).

  13. Caregiving Health Related Quality of Life

    Time frame: Baseline

    Medical Outcome SF-36 Taiwan version

  14. Caregiving Health Related Quality of Life

    Time frame: 2 month after Baseline

    Medical Outcome SF-36 Taiwan version

  15. Caregiving Health Related Quality of Life

    Time frame: 4 month after Baseline

    Medical Outcome SF-36 Taiwan version

  16. Caregiving Health Related Quality of Life

    Time frame: 6 month after Baseline

    Medical Outcome SF-36 Taiwan version

Secondary outcomes

  1. Time Up and Go test

    Time frame: baseline

    assessing fall risk for the persons living with dementia

  2. Time Up and Go test

    Time frame: 2 month after baseline

    assessing fall risk for the persons living with dementia

  3. Time Up and Go test

    Time frame: 4 month after baseline

    assessing fall risk for the persons living with dementia

  4. Time Up and Go test

    Time frame: 6 month after baseline

    assessing fall risk for the persons living with dementia (PLWD)

  5. Activities of Daily Living (ADL)

    Time frame: baseline

    Chinese Barthel Index leasing independence in ADL for PLWD

  6. Activities of Daily Living (ADL)

    Time frame: 2 months after baseline

    Chinese Barthel Index leasing independence in ADL for PLWD

  7. Activities of Daily Living (ADL)

    Time frame: 4 months after baseline

    Chinese Barthel Index leasing independence in ADL for PLWD

  8. Activities of Daily Living (ADL)

    Time frame: 6 months after baseline

    Chinese Barthel Index leasing independence in ADL for PLWD

  9. Instrumental activities of daily living (IADL)

    Time frame: baseline

    Lawton and Brody's IADL measure

  10. Instrumental activities of daily living (IADL)

    Time frame: 2 months after baseline

    Lawton and Brody's IADL measure

  11. Instrumental activities of daily living (IADL)

    Time frame: 4 months after baseline

    Lawton and Brody's IADL measure

  12. Instrumental activities of daily living (IADL)

    Time frame: 6 months after baseline

    Lawton and Brody's IADL measure

  13. Cognitive function

    Time frame: baseline

    Mini-Mental State Examination

  14. Cognitive function

    Time frame: 2 month after baseline

    Mini-Mental State Examination

  15. Cognitive function

    Time frame: 4 month after baseline

    Mini-Mental State Examination

  16. Cognitive function

    Time frame: 6 month after baseline

    Mini-Mental State Examination

  17. Health related quality of life for PLWD

    Time frame: baseline

    Medical Outcomes SF-36 Taiwan Version

  18. Health related quality of life for PLWD

    Time frame: 2 month after baseline

    Medical Outcomes SF-36 Taiwan Version

  19. Health related quality of life for PLWD

    Time frame: 4 month after baseline

    Medical Outcomes SF-36 Taiwan Version

  20. Health related quality of life for PLWD

    Time frame: 6 month after baseline

    Medical Outcomes SF-36 Taiwan Version

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2022
Registry last updated
Nov 21, 2025

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.

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