Upgraded Smart Cloth Home Care System for Persons With Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476809
• Other study ID #: 111-2314-B-182 -010 -MY3
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: July 2022
• Source: Chang Gung Memorial Hospital
• Contact: Yea-Ing L Shyu, PhD
• Phone: 03-2118800
• Email: yeaing[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia
• Family

Intervention

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.

Locations

Country	Name	City	State
Taiwan	New Taipei Tucheng hospital	New Taipei City
Taiwan	Chang Gung Memorial Hospital, Taiwan	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	baseline
Primary	caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	2 months after baseline
Primary	caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	4 months after baseline
Primary	caregiver depressive symptoms	Centre for Epidemiologic Studies Depression Scale (CES-D)	6 months after baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	Baseline
Primary	Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	2 month after Baseline
Primary	Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	4 month after Baseline
Primary	Caregiving Health Related Quality of Life	Medical Outcome SF-36 Taiwan version	6 month after Baseline
Secondary	Time Up and Go test	assessing fall risk for the persons living with dementia	baseline
Secondary	Time Up and Go test	assessing fall risk for the persons living with dementia	2 month after baseline
Secondary	Time Up and Go test	assessing fall risk for the persons living with dementia	4 month after baseline
Secondary	Time Up and Go test	assessing fall risk for the persons living with dementia (PLWD)	6 month after baseline
Secondary	Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	baseline
Secondary	Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	2 months after baseline
Secondary	Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	4 months after baseline
Secondary	Activities of Daily Living (ADL)	Chinese Barthel Index leasing independence in ADL for PLWD	6 months after baseline
Secondary	Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	baseline
Secondary	Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	2 months after baseline
Secondary	Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	4 months after baseline
Secondary	Instrumental activities of daily living (IADL)	Lawton and Brody's IADL measure	6 months after baseline
Secondary	Cognitive function	Mini-Mental State Examination	baseline
Secondary	Cognitive function	Mini-Mental State Examination	2 month after baseline
Secondary	Cognitive function	Mini-Mental State Examination	4 month after baseline
Secondary	Cognitive function	Mini-Mental State Examination	6 month after baseline
Secondary	Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	baseline
Secondary	Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	2 month after baseline
Secondary	Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	4 month after baseline
Secondary	Health related quality of life for PLWD	Medical Outcomes SF-36 Taiwan Version	6 month after baseline