Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000269033
Ethics application status
Approved
Date submitted
19/03/2010
Date registered
1/04/2010
Date last updated
31/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Application of Self-management Systems Trial (ASSET) across three District Health Board regions in New Zealand: A trial to evaluate the effect of telecare self-management devices on quality of life and change in the use of health services in three populations of people suffering from long term conditions including chronic obstructive pulmonary disease, congestive heart failure or diabetes.
Scientific title
Three populations of people suffering from long term conditions working with telecare devices in their home to improve their self-management ability, target clinical intervention and reduce unplanned hospital admissions when compared to three groups who receive usual care.
Secondary ID [1] 1519 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
ASSET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 256996 0
Congestive heart failure 256997 0
Diabetes 256998 0
Condition category
Condition code
Respiratory 257156 257156 0 0
Chronic obstructive pulmonary disease
Cardiovascular 257157 257157 0 0
Other cardiovascular diseases
Metabolic and Endocrine 257199 257199 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the discretion of their health professional, patients will be given technology to use in their homes to monitor their vital statisitics, and have this data then transmitted to a database for clinicians to review and action as necessary. These devices may include such items as a blood pressure cuff and weighing scales, which the intervention group will be asked to use daily for up to 3 months. Patients will receive an initial triaining session, and a follow up session, on how to use the equipment, once they have consented.
Intervention code [1] 256173 0
Treatment: Devices
Intervention code [2] 256213 0
Early detection / Screening
Intervention code [3] 256214 0
Prevention
Comparator / control treatment
Usual care. This is defined as best practice clinical intervention for the 3 disease-states being investigated. This could include the use of vital sign measurement devices, but the patient data will not be electronically transmitted to a database for review, but rather retained in, for a example, a patient diary. the researchers on the ASSET project will ensure they capture what 'usual care' entails for each of the cohorts.
Control group
Active

Outcomes
Primary outcome [1] 258043 0
Increase the health related quality of life and satisfaction with health services for patients and family / whanau via a HRQoL questionnaire (the SF36), an accepted measurement tool.
Timepoint [1] 258043 0
This will be measured at baseline, three months and again at six months
Secondary outcome [1] 263621 0
Decrease unplanned hospital attendance and admissions via a review of hospital and genreal practice medical records.
Timepoint [1] 263621 0
This will be measured at baseline, three months and again at six months

Eligibility
Key inclusion criteria
Age 16+, living permanently at home, expected to be available for 3 months, expected to survive study period, able to communicate in English (or someone in household able to translate), able to physically manage the equipment (or someone available to assist), for the Counties Manukau cohort - must suffer with chronic obstructive pulmonary disease, for the Auckland cohort - must suffer from congestive heart failure, for the Ngati Porou Hauroa cohort - must suffer from diabetes or one of the above disease states.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously used structured and monitored/managed telecare

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The researcher will phone an Interactive Voice Response (IVR) system via an 0800 number, provide basic patient identification data and be assigned a study group for that patient. Simple randomisation will be applied by using a randomisation table created by a computer software (i.e., computerised sequence generation).

Eligible > consent > baseline data collection > individual randomly assigned to intervention or control

In Tairawhiti, patients will not be assigned to separate groups - they will all be part of the intervention group.

Eligible > consent > baseline data collection > followed in telecare programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
However, there will only be a single cohort in Tairawhiti. They will all udertake the intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
171
Accrual to date
Final
Recruitment outside Australia
Country [1] 2553 0
New Zealand
State/province [1] 2553 0

Funding & Sponsors
Funding source category [1] 256673 0
Government body
Name [1] 256673 0
District Health Boards New Zealand
Country [1] 256673 0
New Zealand
Funding source category [2] 256674 0
Government body
Name [2] 256674 0
Ministry of Health
Country [2] 256674 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Health
Address
PO Box 5013
Wellington 6145
Country
New Zealand
Secondary sponsor category [1] 255961 0
University
Name [1] 255961 0
The University of Auckland
Address [1] 255961 0
Private Bag 92019
Auckland 1142
Country [1] 255961 0
New Zealand
Secondary sponsor category [2] 255962 0
University
Name [2] 255962 0
UniServices Limited
Address [2] 255962 0
Private Bag 92019
Auckland 1142
Country [2] 255962 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258700 0
Ethics committee address [1] 258700 0
Ethics committee country [1] 258700 0
Date submitted for ethics approval [1] 258700 0
01/04/2010
Approval date [1] 258700 0
Ethics approval number [1] 258700 0
Ethics committee name [2] 267035 0
Multi-region Ethics Committee
Ethics committee address [2] 267035 0
Ethics committee country [2] 267035 0
New Zealand
Date submitted for ethics approval [2] 267035 0
Approval date [2] 267035 0
12/08/2010
Ethics approval number [2] 267035 0
MEC/10/04/031

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

Contacts
Principal investigator
Name 30961 0
Address 30961 0
Country 30961 0
Phone 30961 0
Fax 30961 0
Email 30961 0
Contact person for public queries
Name 14208 0
Sarah Masson
Address 14208 0
University of Auckland
School of Nursing
Faculty of Medical and Health Sciences
4th Floor ECOM House, 3 Ferncroft Street Grafton
Private Bag 92019
AUCKLAND 1142
Country 14208 0
New Zealand
Phone 14208 0
+64 21 775 475
Fax 14208 0
+64 9 367 7158
Email 14208 0
s.masson@auckland.ac.nz
Contact person for scientific queries
Name 5136 0
Professor Matthew Parsons
Address 5136 0
University of Auckland
School of Nursing
Faculty of Medical and Health Sciences
4th Floor ECOM House, 3 Ferncroft Street Grafton
Private Bag 92019
AUCKLAND 1142
Country 5136 0
New Zealand
Phone 5136 0
+64 9 373 7599 ext 83033
Fax 5136 0
+64 9 367 7158
Email 5136 0
m.parsons@auckland.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
SourceTitleYear of PublicationDOI
EmbaseTelecare for diabetes, CHF or COPD: Effect on quality of life, hospital use and costs. A randomised controlled trial and qualitative evaluation.2015https://dx.doi.org/10.1371/journal.pone.0116188
N.B. These documents automatically identified may not have been verified by the study sponsor.