A Clinical Trial on an Upgraded Smart Cloth Home Care System With Interactive Family Caregiver App for Persons With Dementia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dementia
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Caregiving Balance
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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).
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: 6 months after baseline
Centre for Epidemiologic Studies Depression Scale (CES-D)
Caregiving Health Related Quality of Life
Time Frame: 6 month after Baseline
Medical Outcome SF-36 Taiwan version
Secondary Outcomes
- Activities of Daily Living (ADL)(6 months after baseline)
- Time Up and Go test(6 month after baseline)
- Cognitive function(6 month after baseline)
- Instrumental activities of daily living (IADL)(6 months after baseline)
- Health related quality of life for PLWD(6 month after baseline)