Upgraded Smart Cloth Home Care System for Persons With Dementia

Chang Gung Medical Foundation

Status: Completed

Conditions: Family; Dementia

Treatments: Behavioral: smart-cloth assisted home nursing

Study type: Interventional

Funder types: Other

Identifiers

NCT05476809

111-2314-B-182 -010 -MY3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

smart-cloth

Experimental group

Description:

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.

Treatment:

Behavioral: smart-cloth assisted home nursing

usual care

No Intervention group

Description:

Routine clinical care will be provided to the participants.