Dementia, SenileNCT05063045
Smart-Cloth Care System for Dementia
A study testing smart-cloth assisted home nursing care in people with Dementia, Senile and Family Members, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
Trial summary
The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Senile, Family Members
- What is being tested?
- smart-cloth assisted home nursing care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Aug 2020to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older persons were included by these criteria:
- age 60 or older diagnosed with dementia, or received surgery for a hip fracture could walk independently or with assistance living with family members in northern Taiwan.
- Family caregivers were included by these criteria:
- 20 years old responsible for providing direct care or supervising care received by the patient.
Who cannot join
- Terminal ill Living in institution
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Chang Gung Memorial Hospital
Taipei
Chang Gung Memorial Hospital, Taiwan
Taoyuan
About this study
Official title: Development and Preliminary Effects of Smart Cloth Care System for Persons With Dementia
The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. This will be a three-year study, with the first two years to explore the feasibility of such a smart cloth care system and the third year to pilot test its effects. During the third year, a quasi experimental design will be implemented and the outcomes of caregivers and persons with dementia will be followed for 6 months.
Read the detailed description
The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. A smart-care model, using smart clothing with a remote monitoring system, was developed to assist home-nursing care. Older persons with dementia are asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors are installed in bedrooms and living areas to receive signals from the smart clothing. Alarm at door, emergency button and smoke detector are also installed. The signals and emergency information are transmitted to the mobile phones of responsible home care nurses, who have downloaded an app to their phones. After the home care nurse receive a sensor signal, she would then give feedback to family caregivers about the care receiver, including emergency calls, frequent getting up at night, staying in the bathroom for more than 30 minutes, inadequate or abnormal activity level, not moving during the day for more than 2 hours, leaving the house alone, and a sensor being disconnected from the system. Based on information and signals from smart-care sensors, home care nurses will discuss caregiving activities and planning with family caregivers.Participants were asked to wear smart clothing for at least 4 days/week for 6 months. A home care research nurse will visit the home setting to assess it for sensor installation and suggest environmental modifications for potential hazards. A second visit will be made by an engineer with the research nurse to install the sensors. The research nurse visit the participants' homes once a week during the first month and once every month from the second to third month after the sensor installation to conduct in-home interventions and resolve problems using the smart-care system.
During the first two years, this smart cloth care system will be developed. During the third year. The investigators plan to recruit at least 60 participants and randomize them into an intervention group (N=30) that receives the smart cloth care model and a control group (N=30) that receives usual care. Patient and caregiver outcomes will be followed every two months for a period of 6 months after the smart cloth care system has been implemented. Finally Intention-to-treat and hierarchical linear models will be used to analyze the results.
- Conditions
- Dementia, Senile, Family Members
- Being tested
- smart-cloth assisted home nursing care
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart-cloth assisted home nursing careBehavioural
Older persons with dementia or hip fracture were asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors were installed in bedrooms and living areas to receive signals from the smart clothing. The home care nurses then gave feedback from the sensor signals to family caregivers.
| Study group | Role | What they receive |
|---|---|---|
| smart-cloth | Experimental | Participants receive smart-cloth assisted home nursing care Receives: Behavioral: smart-cloth assisted home nursing care |
| routine care | No intervention | This group receive routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time UP and Go
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Measured: two months after installation
Time UP and Go
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Measured: four months after installation
Time UP and Go
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Measured: six months after installation
Barthel Activity of Daily Living Scale
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Measured: two months after installation
Barthel Activity of Daily Living Scale
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Measured: four months after installation
Barthel Activity of Daily Living Scale
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Measured: six months after installation
IADL self-care ability
dependency in instrumental activities of daily living
Measured: two months after installation
IADL self-care ability
dependency in instrumental activities of daily living
Measured: four months after installation
IADL self-care ability
dependency in instrumental activities of daily living
Measured: six months after installation
cognitive function
Mini-Mental State Examination
Measured: two months after installation
cognitive function
Mini-Mental State Examination
Measured: four months after installation
cognitive function
Mini-Mental State Examination
Measured: six months after installation
Medical Outcome Short Form-36
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Measured: two months after installation
Medical Outcome Short Form-36
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Measured: four months after installation
Medical Outcome Short Form-36
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Measured: six months after installation
Preparedness scale
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Measured: two months after installation
Preparedness scale
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Measured: four months after installation
Preparedness scale
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Measured: six months after installation
Centre for epidemiological Studies Depression Scale
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Measured: two months after installation
Centre for epidemiological Studies Depression Scale
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Measured: four months after installation
Centre for epidemiological Studies Depression Scale
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Measured: six months after installation
caregiver balance scale
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Measured: two months after installation
caregiver balance scale
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Measured: four months after installation
caregiver balance scale
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Measured: six months after installation
Caregiver Medical Outcome Short Form-36
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Measured: two months after installation
Caregiver Medical Outcome Short Form-36
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Measured: four months after installation
Caregiver Medical Outcome Short Form-36
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Measured: six months after installation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Aug 2020
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dementia, SenileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A quasi-experimental design using experimental and control group but without random assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yea-Ing L Shyu, PhD, Principal investigator, School of Nursing, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063045
- Sponsor's protocol ID
- MOST 107-2314-B-182-007
- Status last verified
- Oct 2025
- First submitted
- 15 Sep 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung YL, Huang HL, Chen MC, Lin CC, Hsu WC, Shyu YL. Effect of a Smart Clothes-Assisted Care System for Persons Living With Dementia on Family Caregivers: Longitudinal Nonblinded Quasi-Experimental Study. J Med Internet Res. 2025 Dec 1;27:e66783. doi: 10.2196/66783.
PubMed 41328502Sung YL, Huang HL, Lin CC, Kroger T, Hsu WC, Hsu JL, Lin YE, Shyu YL. Experiences of family caregivers of persons living with dementia with and without a smart- clothes assisted home nursing program during the heightened COVID-19 alert. BMC Geriatr. 2022 Aug 23;22(1):697. doi: 10.1186/s12877-022-03379-8.
PubMed 35996089
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Preliminary Effects of Smart Cloth Care System for Persons With Dementia
- ClinicalTrials.gov ID
- NCT05063045
- Acronym / sponsor ID
- MOST 107-2314-B-182-007
- Conditions
- Dementia, Senile, Family Members
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. This will be a three-year study, with the first two years to explore the feasibility of such a smart cloth care system and the third year to pilot test its effects. During the third year, a quasi experimental design will be implemented and the outcomes of caregivers and persons with dementia will be followed for 6 months.
Detailed description
The purpose of this study is to develop and examine the preliminary effects of a smart cloth care system for facilitating family caregiving for persons with dementia in the home setting. A smart-care model, using smart clothing with a remote monitoring system, was developed to assist home-nursing care. Older persons with dementia are asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors are installed in bedrooms and living areas to receive signals from the smart clothing. Alarm at door, emergency button and smoke detector are also installed. The signals and emergency information are transmitted to the mobile phones of responsible home care nurses, who have downloaded an app to their phones. After the home care nurse receive a sensor signal, she would then give feedback to family caregivers about the care receiver, including emergency calls, frequent getting up at night, staying in the bathroom for more than 30 minutes, inadequate or abnormal activity level, not moving during the day for more than 2 hours, leaving the house alone, and a sensor being disconnected from the system. Based on information and signals from smart-care sensors, home care nurses will discuss caregiving activities and planning with family caregivers.Participants were asked to wear smart clothing for at least 4 days/week for 6 months. A home care research nurse will visit the home setting to assess it for sensor installation and suggest environmental modifications for potential hazards. A second visit will be made by an engineer with the research nurse to install the sensors. The research nurse visit the participants' homes once a week during the first month and once every month from the second to third month after the sensor installation to conduct in-home interventions and resolve problems using the smart-care system.
During the first two years, this smart cloth care system will be developed. During the third year. The investigators plan to recruit at least 60 participants and randomize them into an intervention group (N=30) that receives the smart cloth care model and a control group (N=30) that receives usual care. Patient and caregiver outcomes will be followed every two months for a period of 6 months after the smart cloth care system has been implemented. Finally Intention-to-treat and hierarchical linear models will be used to analyze the results.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A quasi-experimental design using experimental and control group but without random assignment
| Arm | Type | Receives |
|---|---|---|
| smart-cloth | Experimental | Behavioral: smart-cloth assisted home nursing careParticipants receive smart-cloth assisted home nursing care |
| routine care | No intervention | –This group receive routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 60 or older diagnosed with dementia, or received surgery for a hip fracture could walk independently or with assistance living with family members in northern Taiwan.
- 20 years old responsible for providing direct care or supervising care received by the patient.
Key exclusion criteria (1 listed)
- Terminal ill Living in institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smart-cloth assisted home nursing careOlder persons with dementia or hip fracture were asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors were installed in bedrooms and living areas to receive signals from the smart clothing. The home care nurses then gave feedback from the sensor signals to family caregivers. | Behavioural | smart-cloth |
Primary outcome
Time UP and Go
Time frame: two months after installation
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time UP and Go
Time frame: four months after installation
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Time UP and Go
Time frame: six months after installation
Time spends while stand from an armed chair, walk for three meters and come back to sit down
Barthel Activity of Daily Living Scale
Time frame: two months after installation
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Barthel Activity of Daily Living Scale
Time frame: four months after installation
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
Barthel Activity of Daily Living Scale
Time frame: six months after installation
dependency in activities of daily living, 0-100, higher score indicate better activities of daily living.
IADL self-care ability
Time frame: two months after installation
dependency in instrumental activities of daily living
IADL self-care ability
Time frame: four months after installation
dependency in instrumental activities of daily living
IADL self-care ability
Time frame: six months after installation
dependency in instrumental activities of daily living
cognitive function
Time frame: two months after installation
Mini-Mental State Examination
cognitive function
Time frame: four months after installation
Mini-Mental State Examination
cognitive function
Time frame: six months after installation
Mini-Mental State Examination
Medical Outcome Short Form-36
Time frame: two months after installation
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Medical Outcome Short Form-36
Time frame: four months after installation
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Medical Outcome Short Form-36
Time frame: six months after installation
Health-related quality of life, from 0-100, higher score representing better health related quality of life
Preparedness scale
Time frame: two months after installation
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Preparedness scale
Time frame: four months after installation
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Preparedness scale
Time frame: six months after installation
caregiver preparedness for caregiving, 10-50, higher score indicate better preparedness
Centre for epidemiological Studies Depression Scale
Time frame: two months after installation
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Centre for epidemiological Studies Depression Scale
Time frame: four months after installation
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
Centre for epidemiological Studies Depression Scale
Time frame: six months after installation
caregiver depressive symptoms, 0-60, higher score indicate more depressive symptoms
caregiver balance scale
Time frame: two months after installation
caregiving balance between competing needs, 0-3, higher score indicate more balanced
caregiver balance scale
Time frame: four months after installation
caregiving balance between competing needs, 0-3, higher score indicate more balanced
caregiver balance scale
Time frame: six months after installation
caregiving balance between competing needs, 0-3, higher score indicate more balanced
Caregiver Medical Outcome Short Form-36
Time frame: two months after installation
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Caregiver Medical Outcome Short Form-36
Time frame: four months after installation
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Caregiver Medical Outcome Short Form-36
Time frame: six months after installation
caregiver health-related quality of life, from 0-100, higher score representing better health related quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 41328502Sung YL, Huang HL, Chen MC, Lin CC, Hsu WC, Shyu YL. Effect of a Smart Clothes-Assisted Care System for Persons Living With Dementia on Family Caregivers: Longitudinal Nonblinded Quasi-Experimental Study. J Med Internet Res. 2025 Dec 1;27:e66783. doi: 10.2196/66783.
- Derived from this study: PubMed 35996089Sung YL, Huang HL, Lin CC, Kroger T, Hsu WC, Hsu JL, Lin YE, Shyu YL. Experiences of family caregivers of persons living with dementia with and without a smart- clothes assisted home nursing program during the heightened COVID-19 alert. BMC Geriatr. 2022 Aug 23;22(1):697. doi: 10.1186/s12877-022-03379-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yea-Ing L Shyu, PhD principal investigator
School of Nursing, Chang Gung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart-cloth assisted home nursing care in people with Dementia, Senile and Family Members, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time UP and Go (time frame: two months after installation). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05063045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.