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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.
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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.
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Secondary ID [1]
1519
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NA
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Universal Trial Number (UTN)
NA
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Trial acronym
ASSET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease
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Congestive heart failure
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Diabetes
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Condition category
Condition code
Respiratory
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0
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Chronic obstructive pulmonary disease
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Cardiovascular
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0
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Other cardiovascular diseases
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Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Early detection / Screening
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Intervention code [3]
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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This will be measured at baseline, three months and again at six months
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Secondary outcome [1]
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Decrease unplanned hospital attendance and admissions via a review of hospital and genreal practice medical records.
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Assessment method [1]
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Timepoint [1]
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This will be measured at baseline, three months and again at six months
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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.
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Previously used structured and monitored/managed telecare
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
However, there will only be a single cohort in Tairawhiti. They will all udertake the intervention.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/09/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
171
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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District Health Boards New Zealand
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Address [1]
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PO Box 5535
Wellington 6145
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Country [1]
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New Zealand
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Funding source category [2]
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Government body
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Name [2]
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Ministry of Health
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Address [2]
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PO Box 5013
Wellington 6145
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Country [2]
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New Zealand
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Primary sponsor type
Government body
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Name
Ministry of Health
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Address
PO Box 5013
Wellington 6145
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Country
New Zealand
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Auckland
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Address [1]
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Private Bag 92019
Auckland 1142
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Country [1]
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New Zealand
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Secondary sponsor category [2]
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University
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Name [2]
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UniServices Limited
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Address [2]
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Private Bag 92019
Auckland 1142
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Country [2]
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Ethics committee address [1]
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Ethics committee country [1]
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Date submitted for ethics approval [1]
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01/04/2010
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Approval date [1]
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Ethics approval number [1]
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Ethics committee name [2]
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Multi-region Ethics Committee
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Ethics committee address [2]
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133 Molesworth Street Wellington 6145
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Ethics committee country [2]
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New Zealand
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Date submitted for ethics approval [2]
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Approval date [2]
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12/08/2010
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Ethics approval number [2]
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MEC/10/04/031
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Summary
Brief summary
Telecare involves monitoring and caring for people at a distance, such as people with long term conditions, who often need more care as their illness progresses. Telecare is a relatively new development in New Zealand and combines self-monitoring, whereby people with long term conditions monitor their symptoms to track progress, modify behaviours, or medications accordingly or assess when to seek help from health professionals. ASSET will assess the effectiveness of a long term condition telecare intervention on Health Related Quality of Life, as assessed using the Short Form 36 (SF36) interview tool through distinct randomised controlled evaluations in Auckland and Counties Manukau as well as a formative and process evaluation of the telecare intervention in Tairawhiti. Participants will be assessed at baseline with follow up at three (immediately post intervention) and six months (three months post intervention). ASSET will aim to test the hypotheses that compared to conventional care in the community, telecare will (i) Increase the health related quality of life (HRQoL) of people with long term conditions; (ii) Increase time between first and subsequent hospital attendance for these people; (iii) Reduce ambulatory sensitive hospitilisations (ASH) rates; (iv) Improve the HRQoL of the primary informal caregiver; (v) Provide an economically more efficient means for the person, family / whanau, providers and funding agency to manage a person’s long term condition; and (vi) Increase client and family / whanau satisfaction and sense of control. Participating patients are invited to include family/whanau.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sarah Masson
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Address
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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
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Country
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New Zealand
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Phone
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+64 21 775 475
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Fax
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+64 9 367 7158
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Email
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s.masson@auckland.ac.nz
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Contact person for scientific queries
Name
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Professor Matthew Parsons
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Address
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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
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Country
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New Zealand
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Phone
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+64 9 373 7599 ext 83033
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Fax
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+64 9 367 7158
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Email
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m.parsons@auckland.ac.nz
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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
Source
Title
Year of Publication
DOI
Embase
Telecare for diabetes, CHF or COPD: Effect on quality of life, hospital use and costs. A randomised controlled trial and qualitative evaluation.
2015
https://dx.doi.org/10.1371/journal.pone.0116188
N.B. These documents automatically identified may not have been verified by the study sponsor.
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