Comparative Study of QuietCare

Elderly People Clinical Trial

Official title:

Randomized Comparative Study of QuietCare (Motion Sensor System) in Elderly Subjects Living in Assisted/ Independent Living Facilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839825
• Other study ID #: 109-2012-GES-0001
• Status: Completed
• Phase: N/A
• First received: March 30, 2013
• Last updated: September 25, 2014
• Start date: December 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2014
• Source: National Center for Geriatrics and Gerontology, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to examine the efficacy and safety of QuietCare in a randomized, open study in elderly subjects living in assisted/ independent living facilities for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. ability to move independently or by using a walker (without assistance) inside

2. residents using a single room, age 65 or older, of either sex

Exclusion Criteria:

• people who use wheel chairs,

• people who are bed-ridden

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Elderly People
• Living Alone in a Residence With Care Giver

Intervention

Device:
• QuietCare

Locations

Country	Name	City	State
Japan	Sun Home Ogori	Fukuoka

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Geriatrics and Gerontology, Japan	GE Healthcare

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in score of Care Service Quetionnaire	improvement in care level assessment; improvement in care plannning; improvement in communication among staff; improvement in communication with residents and their family	The observation period is 6 months.	No
Primary	Time required for staff to respond to events		The observation period is 6 months.	No
Primary	Incidence of falls		The observation period is 6 months	No
Secondary	Fee for medical and nursing care treatments		The observation period is 6 months	No