Upgraded Smart Cloth Home Care System for Persons With Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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. 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.

Conditions

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Dementia Family

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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smart-cloth

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.

Group Type EXPERIMENTAL

smart-cloth assisted home nursing

Intervention Type 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.

usual care

Routine clinical care will be provided to the participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.