DementiaNCT05476809
Upgraded Smart Cloth Home Care System for Persons With Dementia
A study testing smart-cloth assisted home nursing in people with Dementia and Family, run by Chang Gung Memorial Hospital at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- smart-cloth assisted home nursing
- 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 Nov 2022to 31 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- with terminal illness
- with severe diseases that can not be controlled.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
New Taipei Tucheng hospital
New Taipei City, 236017
Chang Gung Memorial Hospital, Taiwan
Taoyuan
About this study
Official title: A Clinical Trial on an Upgraded Smart Cloth Home Care System With Interactive Family Caregiver App 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.
Read the 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.
- Being tested
- smart-cloth assisted home nursing
- Keywords
- dementia, family caregiver, smart care, home nursing
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart-cloth assisted home nursingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| smart-cloth | Experimental | 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. Receives: Behavioral: smart-cloth assisted home nursing |
| usual care | No intervention | Routine clinical care will be provided to the participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
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.
Measured: 2 months after baseline
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.
Measured: 4 months after baseline
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.
Measured: 6 months after baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Measured: baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Measured: 2 months after baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Measured: 4 months after baseline
caregiver depressive symptoms
Centre for Epidemiologic Studies Depression Scale (CES-D)
Measured: 6 months after baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Measured: Baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Measured: 2 month after Baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Measured: 4 month after Baseline
Caregiving Balance
The degree of balance between competing needs will be measured by the Caregiving Process of Finding a Balance Point measure (Shyu, 2002).
Measured: 6 month after Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Measured: Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Measured: 2 month after Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Measured: 4 month after Baseline
Caregiving Health Related Quality of Life
Medical Outcome SF-36 Taiwan version
Measured: 6 month after Baseline
Secondary outcomes (20)
Time Up and Go test
assessing fall risk for the persons living with dementia
Measured: baseline
Time Up and Go test
assessing fall risk for the persons living with dementia
Measured: 2 month after baseline
Time Up and Go test
assessing fall risk for the persons living with dementia
Measured: 4 month after baseline
Time Up and Go test
assessing fall risk for the persons living with dementia (PLWD)
Measured: 6 month after baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Measured: baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Measured: 2 months after baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Measured: 4 months after baseline
Activities of Daily Living (ADL)
Chinese Barthel Index leasing independence in ADL for PLWD
Measured: 6 months after baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Measured: baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Measured: 2 months after baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Measured: 4 months after baseline
Instrumental activities of daily living (IADL)
Lawton and Brody's IADL measure
Measured: 6 months after baseline
Cognitive function
Mini-Mental State Examination
Measured: baseline
Cognitive function
Mini-Mental State Examination
Measured: 2 month after baseline
Cognitive function
Mini-Mental State Examination
Measured: 4 month after baseline
Cognitive function
Mini-Mental State Examination
Measured: 6 month after baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Measured: baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Measured: 2 month after baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Measured: 4 month after baseline
Health related quality of life for PLWD
Medical Outcomes SF-36 Taiwan Version
Measured: 6 month after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- 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, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476809
- Sponsor's protocol ID
- 111-2314-B-182 -010 -MY3
- Status last verified
- Oct 2025
- First submitted
- 26 Jul 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Clinical Trial on an Upgraded Smart Cloth Home Care System With Interactive Family Caregiver App for Persons With Dementia
- ClinicalTrials.gov ID
- NCT05476809
- Acronym / sponsor ID
- 111-2314-B-182 -010 -MY3
- Keywords
- dementia, family caregiver, smart care, home nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Jul 2022 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| smart-cloth | Experimental | Behavioral: smart-cloth assisted home nursingThe 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. |
| usual care | No intervention | –Routine clinical care will be provided to the participants. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Diagnosed as having dementia
- can walk independently or with help
- able to communicate
- living in Northern Taiwan.
- Family caregiver age 20 or older
Key exclusion criteria (2 listed)
- with terminal illness
- with severe diseases that can not be controlled.
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 nursingThe 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. | Behavioural | smart-cloth |
Primary outcome
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.
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.
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.
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.
caregiver depressive symptoms
Time frame: baseline
Centre for Epidemiologic Studies Depression Scale (CES-D)
caregiver depressive symptoms
Time frame: 2 months after baseline
Centre for Epidemiologic Studies Depression Scale (CES-D)
caregiver depressive symptoms
Time frame: 4 months after baseline
Centre for Epidemiologic Studies Depression Scale (CES-D)
caregiver depressive symptoms
Time frame: 6 months after baseline
Centre for Epidemiologic Studies Depression Scale (CES-D)
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).
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).
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).
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).
Caregiving Health Related Quality of Life
Time frame: Baseline
Medical Outcome SF-36 Taiwan version
Caregiving Health Related Quality of Life
Time frame: 2 month after Baseline
Medical Outcome SF-36 Taiwan version
Caregiving Health Related Quality of Life
Time frame: 4 month after Baseline
Medical Outcome SF-36 Taiwan version
Caregiving Health Related Quality of Life
Time frame: 6 month after Baseline
Medical Outcome SF-36 Taiwan version
20 secondary outcomes
Time Up and Go test
Time frame: baseline
Time Up and Go test
Time frame: 2 month after baseline
Time Up and Go test
Time frame: 4 month after baseline
Time Up and Go test
Time frame: 6 month after baseline
Activities of Daily Living (ADL)
Time frame: baseline
Activities of Daily Living (ADL)
Time frame: 2 months after baseline
Activities of Daily Living (ADL)
Time frame: 4 months after baseline
Activities of Daily Living (ADL)
Time frame: 6 months after baseline
Instrumental activities of daily living (IADL)
Time frame: baseline
Instrumental activities of daily living (IADL)
Time frame: 2 months after baseline
Instrumental activities of daily living (IADL)
Time frame: 4 months after baseline
Instrumental activities of daily living (IADL)
Time frame: 6 months after baseline
Cognitive function
Time frame: baseline
Cognitive function
Time frame: 2 month after baseline
Cognitive function
Time frame: 4 month after baseline
Cognitive function
Time frame: 6 month after baseline
Health related quality of life for PLWD
Time frame: baseline
Health related quality of life for PLWD
Time frame: 2 month after baseline
Health related quality of life for PLWD
Time frame: 4 month after baseline
Health related quality of life for PLWD
Time frame: 6 month after baseline
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.
- 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
Professor
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 in people with Dementia and Family, 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 6 inclusion and 2 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?
caregiver preparedness (time frame: baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.