Comparative Study of QuietCare

September 25, 2014 updated by: Takayuki Hosoi, National Center for Geriatrics and Gerontology, Japan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Sun Home Ogori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QuietCare
QuieCare system installed
Device: QuietCare
Other Names:
  • passive monitoring system using infrared
No Intervention: control
no system installed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in score of Care Service Quetionnaire
Time Frame: The observation period is 6 months.
  • 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
Time Frame: The observation period is 6 months.
The observation period is 6 months.
Incidence of falls
Time Frame: The observation period is 6 months
The observation period is 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Geriatrics and Gerontology, Japan

Collaborators

GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 30, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 25, 2013

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 25, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 109-2012-GES-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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