NCT01839825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

7 months

First QC Date

March 30, 2013

Last Update Submit

September 25, 2014

Conditions

Elderly PeopleLiving Alone in a Residence With Care Giver

Keywords

elderlyfallacute illnesscare giver

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Fee for medical and nursing care treatments

    The observation period is 6 months

Study Arms (2)

QuietCare

EXPERIMENTAL

QuieCare system installed

Device: QuietCare

control

NO INTERVENTION

no system installed

Interventions

QuietCareDEVICE
Also known as: passive monitoring system using infrared
QuietCare

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Home Ogori

Fukuoka, Fukuoka, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Clinical Research and Development

Study Record Dates

First Submitted

March 30, 2013

First Posted

April 25, 2013

Study Start

December 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

September 26, 2014

Record last verified: 2014-09

Locations

JP(1)