Clinical trial NCT05476809: 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
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Family
Keywords: dementia
family caregiver
smart care
home nursing
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: caregiver preparedness
timeFrame: baseline
measure: caregiver preparedness
timeFrame: 2 months after baseline
measure: caregiver preparedness
timeFrame: 4 months after baseline
measure: caregiver preparedness
timeFrame: 6 months after baseline
measure: caregiver depressive symptoms
timeFrame: baseline
measure: caregiver depressive symptoms
timeFrame: 2 months after baseline
measure: caregiver depressive symptoms
timeFrame: 4 months after baseline
measure: caregiver depressive symptoms
timeFrame: 6 months after baseline
measure: Caregiving Balance
timeFrame: Baseline
measure: Caregiving Balance
timeFrame: 2 month after Baseline
measure: Caregiving Balance
timeFrame: 4 month after Baseline
measure: Caregiving Balance
timeFrame: 6 month after Baseline
measure: Caregiving Health Related Quality of Life
timeFrame: Baseline
measure: Caregiving Health Related Quality of Life
timeFrame: 2 month after Baseline
measure: Caregiving Health Related Quality of Life
timeFrame: 4 month after Baseline
measure: Caregiving Health Related Quality of Life
timeFrame: 6 month after Baseline
Secondary outcomes:
measure: Time Up and Go test
timeFrame: baseline
measure: Time Up and Go test
timeFrame: 2 month after baseline
measure: Time Up and Go test
timeFrame: 4 month after baseline
measure: Time Up and Go test
timeFrame: 6 month after baseline
measure: Activities of Daily Living (ADL)
timeFrame: baseline
measure: Activities of Daily Living (ADL)
timeFrame: 2 months after baseline
measure: Activities of Daily Living (ADL)
timeFrame: 4 months after baseline
measure: Activities of Daily Living (ADL)
timeFrame: 6 months after baseline
measure: Instrumental activities of daily living (IADL)
timeFrame: baseline
measure: Instrumental activities of daily living (IADL)
timeFrame: 2 months after baseline
measure: Instrumental activities of daily living (IADL)
timeFrame: 4 months after baseline
measure: Instrumental activities of daily living (IADL)
timeFrame: 6 months after baseline
measure: Cognitive function
timeFrame: baseline
measure: Cognitive function
timeFrame: 2 month after baseline
measure: Cognitive function
timeFrame: 4 month after baseline
measure: Cognitive function
timeFrame: 6 month after baseline
measure: Health related quality of life for PLWD
timeFrame: baseline
measure: Health related quality of life for PLWD
timeFrame: 2 month after baseline
measure: Health related quality of life for PLWD
timeFrame: 4 month after baseline
measure: Health related quality of life for PLWD
timeFrame: 6 month after baseline
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: New Taipei Tucheng hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital, Taiwan
Study officials:
affiliation: Professor
name: Yea-Ing L Shyu, PhD
role: PRINCIPAL_INVESTIGATOR
References: