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Trial registered on ANZCTR


Registration number
ACTRN12612000090819
Ethics application status
Approved
Date submitted
17/01/2012
Date registered
18/01/2012
Date last updated
6/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Smart Patient Monitoring System for Older Adults to provide remote health care
Scientific title
Smart patient monitoring system for advanced remote health care for older adults
Secondary ID [1] 279683 0
Nil
Universal Trial Number (UTN)
U1111-1126-9410
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiological Monitoring 285510 0
Vital signs monitoring 285597 0
Condition category
Condition code
Public Health 285700 285700 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this system vital signs (with informed consent) will be gathered from patients and sent to a control unit for centralized monitoring. The system can complement the role of nurses in monitoring patients’ vital signs. They will be able to focus on holistic needs of patients thereby providing better personal care. Advance and complex medical algorithms will be developed in order to detect several events by using vital signs.

Wireless network technologies will be utilized for transmission of vital signs in the proposed system, as they provide flexibility and mobility to patients. The proposed system will be tested in real-time in public hospital wards after obtaining ethical approval. The capability, suitability and limitation of the chosen technology and the results will be evaluated and validated with two different methods, i.e. comparing with other systems and by agreement with expert using Kappa analysis.

Total 30 participants will be considered. Each participant will be monitored for 5 hours.
Intervention code [1] 283975 0
Diagnosis / Prognosis
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286304 0
Older patient monitoring: Older people can be monitored continuously or periodically from a remote place (home), older people home, rest home, handicap home, or hospital.
This will help reducing work load of medical staff and access to the patient's vital data. This outcome will be validated with two different methods, i.e. comparing with similar remote monitoring systems and by agreement using Kappa analysis.
Timepoint [1] 286304 0
at sixth month after the sample data collected
Primary outcome [2] 286305 0
Early and multiple disease detection: The early detection of the events, by giving a warning or alarm, so that any critical situation can be avoided and depending upon the input parameters, different events can be detected. This outcome will also be validated with two different methods, i.e. comparing with similar monitoring systems and by agreement using Kappa analysis.
Timepoint [2] 286305 0
at sixth month after the sample data collection
Secondary outcome [1] 295573 0
Better health monitoring: Proposed system will monitor patient's vital signs continuously, identify events and alerts medical staff in case of an emergency. This system can be implemented in hospital or home. In case of hospital it will reduce work load of medical staff and in case of home, it will reduce patient's travelling time, money, doctor's time, hospital cost and patient will have its environment freedom. This outcome will be validated by agreement with the expert using Kappa analysis.
Timepoint [1] 295573 0
at one year after the data collection

Eligibility
Key inclusion criteria
Participants above the age of 65 years are considered.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The key exclusion criteria are:
Exclusion of refusal of inform consent,
Hodkinson AMT 7/10 or less (Hodkinson H. M., 1972),
Patients deemed unsuitable by medical or nursing staff,
Terminally ill patients and,
Patients on any other monitoring device.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Kappa Analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
15/09/2012
Date of last participant enrolment
Anticipated
Actual
1/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 4047 0
New Zealand
State/province [1] 4047 0
Auckland

Funding & Sponsors
Funding source category [1] 284466 0
University
Name [1] 284466 0
Auckland University of Technology
Country [1] 284466 0
New Zealand
Primary sponsor type
Individual
Name
Professor Martin J. Connolly
Address
University of Auckland and Waitemata District Health Board,
Shakespeare Road, PO Box 93 503, Takapuna, North Shore 0740.
Country
New Zealand
Secondary sponsor category [1] 283452 0
Individual
Name [1] 283452 0
Dr. Hamid GholamHosseini
Address [1] 283452 0
31-33 Symonds Street,
Level 2, WL Building, School of Engineering,
AUT University, Auckland, 1142,
Private Bag: 92006
Country [1] 283452 0
New Zealand
Secondary sponsor category [2] 283453 0
Individual
Name [2] 283453 0
Mirza Mansoor Baig
Address [2] 283453 0
31-33 Symonds Street,
Level 2, WL Building, School of Engineering
AUT University, Auckland, 1142,
Private Bag: 92006
Country [2] 283453 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286448 0
Health and Disability Ethics Committee
Ethics committee address [1] 286448 0
Ethics committee country [1] 286448 0
New Zealand
Date submitted for ethics approval [1] 286448 0
01/03/2012
Approval date [1] 286448 0
01/06/2012
Ethics approval number [1] 286448 0
NTX/12/EXP/073/AM01
Ethics committee name [2] 294973 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 294973 0
Ethics committee country [2] 294973 0
New Zealand
Date submitted for ethics approval [2] 294973 0
13/01/2012
Approval date [2] 294973 0
07/05/2012
Ethics approval number [2] 294973 0
12/117

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33600 0
A/Prof Hamid GholamHosseini
Address 33600 0
31-33 Symonds Street, Level 2, WL Building, School of Engineering AUT University, Auckland, 1142, Private Bag: 92006
Country 33600 0
New Zealand
Phone 33600 0
+64 9 921 9999 ext: 8755
Fax 33600 0
Email 33600 0
hgholamh@aut.ac.nz
Contact person for public queries
Name 16847 0
Hamid GholamHosseini
Address 16847 0
31-33 Symonds Street,
Level 2, WL Building, School of Engineering
AUT University, Auckland, 1142,
Private Bag: 92006
Country 16847 0
New Zealand
Phone 16847 0
+64 9 921 9999 ext: 8755
Fax 16847 0
+64 9 921 9973
Email 16847 0
hgholamh@aut.ac.nz
Contact person for scientific queries
Name 7775 0
Hamid GholamHosseini
Address 7775 0
31-33 Symonds Street,
Level 2, WL Building, School of Engineering
AUT University, Auckland, 1142,
Private Bag: 92006
Country 7775 0
New Zealand
Phone 7775 0
+64 9 921 9999 ext: 8755
Fax 7775 0
+64 9 921 9973
Email 7775 0
hgholamh@aut.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.