Comparative Study of QuietCare | NCT01839825

Studies
Comparative Study of QuietCare

NCT01839825

Sponsor

National Center for Geriatrics and Gerontology, Japan

Status

Completed

Last Update Posted

Sep 26, 2014Estimated

Enrollment

202Actual

Phase

Not Applicable

Conditions

Elderly People
Living Alone in a Residence With Care Giver

Interventions

QuietCare

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 30, 2013

First Submission Date that Met QC Criteria

Apr 22, 2013

First Posted Date

Apr 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2014

Last Update Posted Date

Sep 26, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Takayuki Hosoi, Director, Clinical Research and Development, National Center for Geriatrics and Gerontology, JapanPrincipal Investigator

Lead Sponsor

National Center for Geriatrics and Gerontology, JapanOTHER

Collaborators

Name	Class
GE Healthcare	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QuietCare	Experimental	QuieCare system installed	Device: QuietCare
control	No Intervention	no system installed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QuietCare	Device		QuietCare	passive monitoring system using infrared

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.
Time required for staff to respond to events		The observation period is 6 months.
Incidence of falls		The observation period is 6 months

Secondary Outcomes

Measure	Description	Time Frame
Fee for medical and nursing care treatments		The observation period is 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ability to move independently or by using a walker (without assistance) inside
residents using a single room, age 65 or older, of either sex

Exclusion Criteria:

people who use wheel chairs,
people who are bed-ridden

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Home Ogori		Fukuoka	Fukuoka		Japan