Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000517471
Ethics application status
Approved
Date submitted
2/10/2007
Date registered
9/10/2007
Date last updated
22/10/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian CareLink Quality and Impact
of Remote Follow-Up Evaluation Study (The ACQUIRE Study); to assess time and financial burden for device follow-up in patients with a pacemaker, implantable cardioverter defibrillator or cardiac resynchronisation therapy device.
Scientific title
The ACQUIRE Study: To assess the impact of remote device follow-up on time and financial burden in patients with a pacemaker, implantable cardioverter defibrillator or cardiac resynchronisation therapy device.
Universal Trial Number (UTN)
Trial acronym
The ACQUIRE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Remote monitoring of implanted cardiac devices: Pacemaker, Implantable Cardioverter Defibrillator (ICD) or cardiac resynchronisation therapy (CRT) device 2417 0
Condition category
Condition code
Cardiovascular 2524 2524 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Medtronic CareLink Network is a system which allows patients with a CareLink monitor, to transmit data from their implanted device to their doctor directly from home using their phone line. Over 9 months a combination of clinic visits and CareLink transmissions will occur allowing comparison of the characteristics of the 2 methods for device follow-up.
Intervention code [1] 2141 0
Not applicable
Comparator / control treatment
Data from all participants will be collected at both the in-clinic visit and a remote follow-up monitor transmission.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3422 0
Patient and clinician time burden
Timepoint [1] 3422 0
Baseline, 3 months, 6 months and study closure
Primary outcome [2] 3423 0
Patient and clinician financial burden
Timepoint [2] 3423 0
Baseline, 3 months, 6 months and study closure
Secondary outcome [1] 5683 0
Patient and Clinician Ease of Use and Acceptance of CareLink
Timepoint [1] 5683 0
3 months, 6 months and study closure

Eligibility
Key inclusion criteria
Patient is scheduled to receive (or has a previously implanted) IPG, ICD or CRT device that is supported by the Medtronic CareLink Network.
Patient has access to a telephone line where they reside, and are willing and able to use the Medtronic CareLink Monitor and perform the required duties at home or have a family member or assistant perform those duties.
Patient signs the study consent form and agrees to comply with all study requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient is enrolled in, or intends to participate in, another clinical trial that might conflict with this study.
Patient has medical conditions that would limit study participation (e.g. hearing or speech impaired with no family member or assistant available).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
225
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 442 0
4032
Recruitment postcode(s) [2] 443 0
4000
Recruitment postcode(s) [3] 444 0
3550
Recruitment postcode(s) [4] 445 0
5000
Recruitment postcode(s) [5] 446 0
4066

Funding & Sponsors
Funding source category [1] 2671 0
Commercial sector/Industry
Name [1] 2671 0
Medtronic Australasia Pty Ltd
Country [1] 2671 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Australasia Pty Ltd
Address
PO Box 386
Kew East, VIC 3102
Country
Australia
Secondary sponsor category [1] 2413 0
None
Name [1] 2413 0
Address [1] 2413 0
Country [1] 2413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4589 0
Ethics committee address [1] 4589 0
Ethics committee country [1] 4589 0
Date submitted for ethics approval [1] 4589 0
01/10/2007
Approval date [1] 4589 0
Ethics approval number [1] 4589 0
EC00168

Summary
Brief summary
Cardiology patients who receive an implanted device (pacemaker, implantable cardioverter defibrillator or cardiac resynchronisation therapy device) return to their doctor on a regular basis to have their device interrogated and followed-up. There is a new method of following-up these devices from the patient’s home called the Medtronic CareLink Network. Patients use a Monitor to interrogate their implanted device (that is, to collect information from the device using the antenna attached to the Monitor). The monitor then uses an analogue “landline” to send the encrypted data to the central database. Clinicians can access the information from the patient’s implanted devices by logging into the secure, password-protected Website.
The goal of the ACQUIRE Study is to assess the impact of remote device monitoring on time and financial burden for patients, clinicians and clinics themselves. Furthermore, the acceptance, ease of use, satisfaction and impact of the system will be assessed for both patients and clinicians, respectively. The time and financial impact will be investigated in order to better understand the potential value to economic stakeholders. The economic stakeholders include patients, caregivers, clinicians, and health care systems.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28085 0
Address 28085 0
Country 28085 0
Phone 28085 0
Fax 28085 0
Email 28085 0
Contact person for public queries
Name 11242 0
Arianne Lee
Address 11242 0
PO Box 386
Kew East VIC 3102
Country 11242 0
Australia
Phone 11242 0
+61 3 8851 1004 (for Melbourne Australia)
Fax 11242 0
+61 3 9857 0692 (for Melbourne Australia)
Email 11242 0
[email protected]
Contact person for scientific queries
Name 2170 0
Arianne Lee
Address 2170 0
PO Box 386
Kew East VIC 3102
Country 2170 0
Australia
Phone 2170 0
+61 3 8851 1004 (for Melbourne Australia)
Fax 2170 0
+61 3 9857 0692 (for Melbourne Australia)
Email 2170 0
[email protected]

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.