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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| usual care | No Intervention | Routine clinical care will be provided to the participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smart-cloth assisted home nursing | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) | baseline |
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) | 2 months after baseline |
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) |
| Measure | Description | Time Frame |
|---|---|---|
| Time Up and Go test | assessing fall risk for the persons living with dementia | baseline |
| Time Up and Go test | assessing fall risk for the persons living with dementia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yea-Ing L Shyu, PhD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Taipei Tucheng hospital | New Taipei City | 236017 | Taiwan | |||
| Chang Gung Memorial Hospital, Taiwan |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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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.
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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.
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| 4 months after baseline |
| caregiver depressive symptoms | Centre for Epidemiologic Studies Depression Scale (CES-D) | 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). | 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). | 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). | 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). | 6 month after Baseline |
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | Baseline |
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | 2 month after Baseline |
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | 4 month after Baseline |
| Caregiving Health Related Quality of Life | Medical Outcome SF-36 Taiwan version | 6 month after Baseline |
| 2 month after baseline |
| Time Up and Go test | assessing fall risk for the persons living with dementia | 4 month after baseline |
| Time Up and Go test | assessing fall risk for the persons living with dementia (PLWD) | 6 month after baseline |
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | baseline |
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | 2 months after baseline |
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | 4 months after baseline |
| Activities of Daily Living (ADL) | Chinese Barthel Index leasing independence in ADL for PLWD | 6 months after baseline |
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | baseline |
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | 2 months after baseline |
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | 4 months after baseline |
| Instrumental activities of daily living (IADL) | Lawton and Brody's IADL measure | 6 months after baseline |
| Cognitive function | Mini-Mental State Examination | baseline |
| Cognitive function | Mini-Mental State Examination | 2 month after baseline |
| Cognitive function | Mini-Mental State Examination | 4 month after baseline |
| Cognitive function | Mini-Mental State Examination | 6 month after baseline |
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | baseline |
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | 2 month after baseline |
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | 4 month after baseline |
| Health related quality of life for PLWD | Medical Outcomes SF-36 Taiwan Version | 6 month after baseline |
| Taoyuan |
| Taiwan |
| D001523 | Mental Disorders |