Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000295549
Ethics application status
Not yet submitted
Date submitted
7/07/2006
Date registered
11/07/2006
Date last updated
11/07/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Care Assessment Platform Research Project
Scientific title
The use of ambulatory monitoring devices to develop a software platform that can support the delivery of community based care for people with or at risk of developing cardiovascular or chronic obstructive pulmonary disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular diseases (coronary heart disease, heart failure and stroke). 1269 0
Chronic Obstructive Pulmonary Disease (COPD) 1270 0
Condition category
Condition code
Cardiovascular 1355 1355 0 0
Coronary heart disease
Stroke 1356 1356 0 0
Respiratory 1357 1357 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study involves continuous monitoring of movement and cardiac signals in three patient groups:
1. Management and tertiary prevention: patients with developed cardiovascular diseases and/or COPD that are assessed and managed by Home Based Acute Care services.
2. Secondary prevention: early detection and early management of disease markers. These patients live at home at attend rehab clinics twice weekly for exercise and other intervention therapy.
3. Primary prevention: preventing and reducing risk factors. This cohort will be healthy community participants, serving as a control group.
Participants will be monitored 24hours/day for 10-15 weeks, using a device worn on the hip, containing accelerometers and a single channel ECG module, connected to the chest via leads & adhesive electrode pads.
The following observations will be made at the completion of the study:
• Degree of adjustment to patient therapy as a result of frequent / continuous assessment of mobility;
• Ability to identify patients that respond well to certain exercise /education from those that don’t respond;
• Patient activity levels through the week between visits to rehabilitation clinics;
• Extent of changes in activity levels as a direct consequence of modifying medications;
• Contribution of ECG monitoring to the management and care of participants;
• Duplication levels in patient assessment;
• Ability to use monitoring for benchmarking rehabilitation services;
• Patient and clinician perceived continuum of care and communication of health information;
• Activity levels of study participants over previous levels;
• Hospital admission and length of stay data for participants in the study.
Intervention code [1] 1191 0
Rehabilitation
Comparator / control treatment
3. Primary prevention: preventing and reducing risk factors. This cohort will be healthy community participants, serving as a control group.
Control group

Outcomes
Primary outcome [1] 1850 0
The outcome of this trial is primarily to develop a software platform based on the results of the monitoring.
Timepoint [1] 1850 0
The development of the software platform will be undertaken throughout the study period.
Secondary outcome [1] 3250 0
In addition to the development of a software tool (primary outcome) there may be health benefits delivered by this study. These additional outcomes may include:
Timepoint [1] 3250 0
Secondary outcome [2] 3251 0
• adjustments to patient therapy that could not be made in the absence of continuous personal monitoring;
Timepoint [2] 3251 0
Secondary outcome [3] 3252 0
• identification of patients that respond well to certain exercise /education programs from those that don’t respond;
Timepoint [3] 3252 0
Secondary outcome [4] 3253 0
• quantifying patient activity levels at home;
Timepoint [4] 3253 0
Secondary outcome [5] 3254 0
• quantifying impact of modifying medications on patient activity levels;
Timepoint [5] 3254 0
Secondary outcome [6] 3255 0
• identification of the role of Electrocardiogram (ECG) monitoring to the management and care of participants;
Timepoint [6] 3255 0
Secondary outcome [7] 3256 0
• reductions in duplication of patient assessment;
Timepoint [7] 3256 0
Secondary outcome [8] 3257 0
• availability of a new tool for benchmarking rehabilitation services;
Timepoint [8] 3257 0
Secondary outcome [9] 3258 0
• improved continuum of care and communication of health information;
Timepoint [9] 3258 0
Secondary outcome [10] 3259 0
• increased activity levels of study participants over previous levels;
Timepoint [10] 3259 0
Secondary outcome [11] 3260 0
• reduced hospital admissions and lengths of hospital stay for participants in the study.
Timepoint [11] 3260 0
Secondary outcome [12] 3261 0
These benefits are desired outcomes from the software development and measured at the completion of the study period.
Timepoint [12] 3261 0

Eligibility
Key inclusion criteria
Accessing clinical services through the North Lakes Models of Care, displaying symptoms or risk factors of cardiovascular diseases or COPD.• Community volunteers consenting to act as a healthy control group.• Participants who are assessed as being competent to consent to their participation in the study, or who have a competent caregiver who can consent on their behalf.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with permanent or temporary cardiac pacemakers and other implantable devices.• Patients using electrical infusion devices. • People fitted with other patient-borne electronic devices except external hearing aids.• People assessed as having an “at risk” skin assessment.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1486 0
Government body
Name [1] 1486 0
Queensland Health
Country [1] 1486 0
Australia
Funding source category [2] 1487 0
Government body
Name [2] 1487 0
CSIRO
Country [2] 1487 0
Australia
Primary sponsor type
Government body
Name
CSIRO (E-Health Research Centre)
Address
Country
Australia
Secondary sponsor category [1] 1309 0
Government body
Name [1] 1309 0
Queensland Health
Address [1] 1309 0
Country [1] 1309 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2911 0
Redcliffe - Caboolture Health Service District HREC
Ethics committee address [1] 2911 0
Ethics committee country [1] 2911 0
Australia
Date submitted for ethics approval [1] 2911 0
Approval date [1] 2911 0
12/07/2006
Ethics approval number [1] 2911 0

Summary
Brief summary
The project will involve monitoring a patient’s activity levels and vital signs to determine their response to targeted exercise therapy, education programs and changes in medications. This data will be measured using an externally worn monitoring device. Changes in medications and related health observations will be captured using a form.
Patient’s perceived Quality-of-Life, self assessed activity levels and trial feedback (satisfaction, inconvenience etc) will also be captured by questionnaire.
It is also desired to link hospital readmission and length of stay measures with the involvement of participants in the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35481 0
Address 35481 0
Country 35481 0
Phone 35481 0
Fax 35481 0
Email 35481 0
Contact person for public queries
Name 10380 0
Jo Walters
Address 10380 0
North Lakes Project
Redcliffe Hospital
Anzac Ave, Redcliffe, Qld, 4020
Country 10380 0
Australia
Phone 10380 0
07 38837851
Fax 10380 0
Email 10380 0
[email protected]
Contact person for scientific queries
Name 1308 0
Justin Boyle
Address 1308 0
PO Box 10842
Adelaide St
Brisbane Qld 4000
Country 1308 0
Australia
Phone 1308 0
07 30241606
Fax 1308 0
Email 1308 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.