Development of an Integrated Health Care Environment for... | NCT00748683

Studies
Development of an Integrated Health Care Environment for Elderly With RFID Technology

NCT00748683

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Dec 15, 2009Estimated

Enrollment

15Estimated

Phase

Early Phase 1

Conditions

Elderly

Interventions

RFID

Countries

Taiwan

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 2008

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

Sep 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Sep 1, 2008

First Submission Date that Met QC Criteria

Sep 5, 2008

First Posted Date

Sep 8, 2008Estimated

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

Dec 14, 2009

Last Update Posted Date

Dec 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

A falling prevention system will be established by RFID location and motion detection.

Using RFID to detect participants' allocation indoor.
Modifying environment parameters such as light, sound, to alert users if them enter a place with potential hazards.

Data exchange models will also developed in this project

Interchanging different data including physiological data and RFID data into a database
establishing interchange protocol according the HL7 standard

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RFID	Other	A RFID tag attached on subjects' clothes 24hr a day during 1 month.

Measure	Description	Time Frame
Falling rate of participants		End of study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age above 65 year old
Living in the Nursing home, Bei-Hu Branch, National Taiwan University Hospital
with ability to independent ambulation (with or without assistive devices)

Exclusion Criteria:

no ability to independent ambulation
with infective diseases.

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

Name	Affiliation	Role
Jin-Shin Lai, M.D.	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nursing Home, Bei-Hu Branch, National Taiwan University Hospital		Taipei		100	Taiwan

Intervention Browse Module

MeSH Terms

ID	Term
D057233	Radio Frequency Identification Device

Ancestor Terms

ID	Term
D004864	Equipment and Supplies
D010355	Patient Identification Systems
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided