Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12608000139370
Ethics application status
Approved
Date submitted
10/02/2008
Date registered
18/03/2008
Date last updated
15/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quality of life assessment in pulmonary arterial hypertension
Scientific title
Quality of life assessment in pulmonary arterial hypertension. The validation and investigation of responsiveness of the Cambridge Pulmonary Hypertension Outcome Review in an Australian and New Zealand population with pulmonary arterial hypertension
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of life 2805 0
Pulmonary arterial hypertension 2806 0
Condition category
Condition code
Cardiovascular 2942 2942 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a quality of life (QoL) measure with three subscales: symptoms, activities and QoL. This study aims to validate the CAMPHOR in Australia and New Zealand. Firstly, interviews will be conducted to ensure the language and content of the CAMPHOR is appropriate for our population. Subsequently, test-retest reliability of the CAMPHOR will be performed at several hospitals within Australia and New Zealand.
Intervention code [1] 2544 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3824 0
Quality of life questionnaire (CAMPHOR) scores
Timepoint [1] 3824 0
test, retest (2 weeks)
Secondary outcome [1] 6449 0
Nil
Timepoint [1] 6449 0
Nil

Eligibility
Key inclusion criteria
Diagnosis of pulmonary arterial hypertension
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking
Major psychological or mood disorders
Cognitive impairment that precludes informed consent and ability to complete questionnaires and follow instructions
Severe musculoskeletal limitations that impair exercise performance
Severe neurological limitations
Co-morbid cardiovascular and/or pulmonary disease

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 571 0
6000
Recruitment outside Australia
Country [1] 784 0
New Zealand
State/province [1] 784 0
4710

Funding & Sponsors
Funding source category [1] 3067 0
Charities/Societies/Foundations
Name [1] 3067 0
Western Australian Heart and Lung Transplant Foundation
Country [1] 3067 0
Australia
Funding source category [2] 3068 0
Commercial sector/Industry
Name [2] 3068 0
Bayer Schering Pharma
Country [2] 3068 0
Australia
Primary sponsor type
University
Name
Curtin University of Technology
Address
Kent Street
Bentley
Perth Western Australia 6102
Country
Australia
Secondary sponsor category [1] 2764 0
Hospital
Name [1] 2764 0
Royal Perth Hospital
Address [1] 2764 0
Wellington Street
Perth Western Australia 6000
Country [1] 2764 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5015 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 5015 0
Royal Perth Hospital
Wellington Street
Perth Western Australia 6000
Ethics committee country [1] 5015 0
Australia
Date submitted for ethics approval [1] 5015 0
Approval date [1] 5015 0
18/01/2008
Ethics approval number [1] 5015 0
Ethics committee name [2] 5016 0
Curtin University of Technology Human Research Ethics Committee
Ethics committee address [2] 5016 0
GP Box U1987
Perth Western Australia 6845
Ethics committee country [2] 5016 0
Australia
Date submitted for ethics approval [2] 5016 0
Approval date [2] 5016 0
08/02/2008
Ethics approval number [2] 5016 0

Summary
Brief summary
The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is the only available questionnaire specifically developed for patients with pulmonary arterial hypertension (PAH). The CAMPHOR has been used in the United Kingdom to measure quality of life (QoL) in patients with PAH. This study aims to investigate whether the CAMPHOR is a useful questionnaire for an Australian and New Zealand group of patients with PAH, as well as to see whether it more accurately reflects changes in QoL in this group when compared to a widely used generic QoL questionnaire (the Short Form 36). Measuring QoL is important outcome measure to determine the effectiveness of treatment from the patient’s perspective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28360 0
Address 28360 0
Country 28360 0
Phone 28360 0
Fax 28360 0
Email 28360 0
Contact person for public queries
Name 11517 0
Louise Ganderton
Address 11517 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 11517 0
Australia
Phone 11517 0
+61 8 92242076
Fax 11517 0
Email 11517 0
[email protected]
Contact person for scientific queries
Name 2445 0
Louise Ganderton
Address 2445 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 2445 0
Australia
Phone 2445 0
+61 8 92242076
Fax 2445 0
Email 2445 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.