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Upgraded Smart Cloth Home Care System for Persons With Dementia

Primary Purpose

Dementia, Family

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
smart-cloth assisted home nursing
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring dementia, family caregiver, smart care, home nursing

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New Taipei Tucheng hospitalRecruiting
  • Chang Gung Memorial Hospital, TaiwanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

smart-cloth

usual care

Arm Description

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.

Routine clinical care will be provided to the participants.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2022
Last Updated
January 4, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05476809
Brief Title
Upgraded Smart Cloth Home Care System for Persons With Dementia
Official Title
A Clinical Trial on an Upgraded Smart Cloth Home Care System With Interactive Family Caregiver App for Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Family
Keywords
dementia, family caregiver, smart care, home nursing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
smart-cloth
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
Routine clinical care will be provided to the participants.
Intervention Type
Behavioral
Intervention Name(s)
smart-cloth assisted home nursing
Intervention Description
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 Outcome Measure Information:
Title
caregiver preparedness
Description
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
Title
caregiver preparedness
Description
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
Title
caregiver preparedness
Description
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
Title
caregiver preparedness
Description
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
Title
caregiver depressive symptoms
Description
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
baseline
Title
caregiver depressive symptoms
Description
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
2 months after baseline
Title
caregiver depressive symptoms
Description
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
4 months after baseline
Title
caregiver depressive symptoms
Description
Centre for Epidemiologic Studies Depression Scale (CES-D)
Time Frame
6 months after baseline
Title
Caregiving Balance
Description
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
Title
Caregiving Balance
Description
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
Title
Caregiving Balance
Description
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
Title
Caregiving Balance
Description
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
Title
Caregiving Health Related Quality of Life
Description
Medical Outcome SF-36 Taiwan version
Time Frame
Baseline
Title
Caregiving Health Related Quality of Life
Description
Medical Outcome SF-36 Taiwan version
Time Frame
2 month after Baseline
Title
Caregiving Health Related Quality of Life
Description
Medical Outcome SF-36 Taiwan version
Time Frame
4 month after Baseline
Title
Caregiving Health Related Quality of Life
Description
Medical Outcome SF-36 Taiwan version
Time Frame
6 month after Baseline
Secondary Outcome Measure Information:
Title
Time Up and Go test
Description
assessing fall risk for the persons living with dementia
Time Frame
baseline
Title
Time Up and Go test
Description
assessing fall risk for the persons living with dementia
Time Frame
2 month after baseline
Title
Time Up and Go test
Description
assessing fall risk for the persons living with dementia
Time Frame
4 month after baseline
Title
Time Up and Go test
Description
assessing fall risk for the persons living with dementia (PLWD)
Time Frame
6 month after baseline
Title
Activities of Daily Living (ADL)
Description
Chinese Barthel Index leasing independence in ADL for PLWD
Time Frame
baseline
Title
Activities of Daily Living (ADL)
Description
Chinese Barthel Index leasing independence in ADL for PLWD
Time Frame
2 months after baseline
Title
Activities of Daily Living (ADL)
Description
Chinese Barthel Index leasing independence in ADL for PLWD
Time Frame
4 months after baseline
Title
Activities of Daily Living (ADL)
Description
Chinese Barthel Index leasing independence in ADL for PLWD
Time Frame
6 months after baseline
Title
Instrumental activities of daily living (IADL)
Description
Lawton and Brody's IADL measure
Time Frame
baseline
Title
Instrumental activities of daily living (IADL)
Description
Lawton and Brody's IADL measure
Time Frame
2 months after baseline
Title
Instrumental activities of daily living (IADL)
Description
Lawton and Brody's IADL measure
Time Frame
4 months after baseline
Title
Instrumental activities of daily living (IADL)
Description
Lawton and Brody's IADL measure
Time Frame
6 months after baseline
Title
Cognitive function
Description
Mini-Mental State Examination
Time Frame
baseline
Title
Cognitive function
Description
Mini-Mental State Examination
Time Frame
2 month after baseline
Title
Cognitive function
Description
Mini-Mental State Examination
Time Frame
4 month after baseline
Title
Cognitive function
Description
Mini-Mental State Examination
Time Frame
6 month after baseline
Title
Health related quality of life for PLWD
Description
Medical Outcomes SF-36 Taiwan Version
Time Frame
baseline
Title
Health related quality of life for PLWD
Description
Medical Outcomes SF-36 Taiwan Version
Time Frame
2 month after baseline
Title
Health related quality of life for PLWD
Description
Medical Outcomes SF-36 Taiwan Version
Time Frame
4 month after baseline
Title
Health related quality of life for PLWD
Description
Medical Outcomes SF-36 Taiwan Version
Time Frame
6 month after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yea-Ing L Shyu, PhD
Phone
03-2118800
Ext
5736
Email
yeaing@mail.cgu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Taipei Tucheng hospital
City
New Taipei City
ZIP/Postal Code
236017
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Facility Name
Chang Gung Memorial Hospital, Taiwan
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ing L Shyu, PhD
Phone
+886-3-2118800
Ext
5736
Email
yeaing@mail.cgu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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Upgraded Smart Cloth Home Care System for Persons With Dementia

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