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Trial registered on ANZCTR
Registration number
ACTRN12609000017224
Ethics application status
Approved
Date submitted
7/11/2008
Date registered
8/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
A qualitative exploration of the needs of patients with severe chronic obstructive pulmonary disease (COPD)
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Scientific title
A qualitative exploration of the needs of patients with severe chronic obstructive pulmonary disease (COPD)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease (COPD)
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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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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Observational study - end of life issues for patients with severe COPD and their family members.
a) Chronic obstructive pulmonary disease (COPD) is a common diagnosis, representing the 4th most common cause of death in Australia. It is associated with a similar symptom burden and prognosis as many cancer diagnoses, yet patients suffering this illness frequently do not receive coordinated end of life care, including palliative care.
This study aims to (1) identify the concerns of patients with severe COPD and their families including physical, emotional, and social, (2) obtain insights into bereaved families’ experiences of caring for someone with COPD and their end of life care, (3) explore staff perceptions of the palliative care needs of COPD patients (and their families), and (4) explore the information needs of patients, families, bereaved families and staff with particular focus upon the illness course, prognosis and goals of care.
b) Semi-structured in-depth interviews will take place with patients who have COPD, with family members and with bereaved family members. Focus groups will be held with health care professionals.
c) It is anticipated that the information obtained from the study will be combined with results from epidemiological and quantitative investigations to inform how palliative care may best serve the COPD population. In turn it is anticipated this will assist with the management of the significant symptom burden and care planning associated with advanced COPD. The revised model of palliative care based upon COPD will potentially have broad and helpful applications to other chronic, non-malignant illnesses which follow a relapsing progressive course, such as congestive cardiac failure.
d) Semi-structured interviews will be conducted by a palliative care research nurse and the focus groups will be conducted by a palliative care physician.
e) Semi-structured interviews and focus groups will be conducted at a time and place suitable to the participant. The project is anticipated to run from April 2008 to April 2009.
f) The semi-structured interviews and focus groups will take approximately 1 hour.
g) Patients, family members and bereaved family members will particpate in ONE semi-structured interviews. Health care professionals will particpate in ONE focus group.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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(1) identify the concerns of patients with severe COPD and their families including physical, emotional, and social.
This will be observed/measured by means of a semi-structured interview.
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Assessment method [1]
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Timepoint [1]
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This will be observed/measured by a one-off semi-structured interview
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Primary outcome [2]
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(2) obtain insights into bereaved families experiences of caring for someone with COPD and their end of life care.
This will be observed/measured by means of a semi-structured interview.
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Assessment method [2]
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Timepoint [2]
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This will be observed/measured by a one-off semi-structured interview
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Primary outcome [3]
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(3) explore staff perceptions of the palliative care needs of COPD patients (and their families)
This will be observed/measured by a semi-structured interview or focus group.
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Assessment method [3]
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Timepoint [3]
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This will be observed/measured by a one-off semi-structured interview or focus group
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Secondary outcome [1]
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Explore the information needs of patients, families, bereaved families and staff with particular focus upon the illness course, prognosis and goals of care.
This will be observed/measured by a one-off semi-structured interview or focus group
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Assessment method [1]
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Timepoint [1]
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This will be observed/measured by a one-off semi-structured interview or focus group
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Eligibility
Key inclusion criteria
Patients with severe COPD
Family members of patients with severe COPD
Bereaved family members of patients with severe COPD
Health Care Professionals who work with patients with severe COPD
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Minimum age
18
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
Non english speaking
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Both
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/10/2008
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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
52
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Bethlehem Griffiths Research Foundation
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Address [1]
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476 Kooyong Road, Caulfield, VIC 3162
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Centre for Palliative Care Education and Research
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Address
St Vincent's & The University of Melbourne
PO Box 2900
Fitzroy Victoria 3065
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Alfred Hospital Research and Ethics Comittee
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Ethics committee address [1]
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The Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
6201
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Approval date [1]
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29/07/2008
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Ethics approval number [1]
6201
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Summary
Brief summary
This study is exploratory in focus, and aims to (1) identify the concerns of patients with severe COPD and their families including physical, emotional and social, (2) obtain insights into bereaved families’ experiences of caring for someone with COPD and their end of life care, (3) explore the staff perceptions of the palliative care needs of patients (and their families) with
severe COPD, and (4) identify points when information about illness course, prognosis and goals of care are perceived as critical by patients, families, bereaved families and staff.
Semi-structured in-depth interviews will take place with patients who have COPD, with family members and with bereaved family members. Focus groups will be held with health care professionals. Data will be analysed using a phenomenological approach, giving rise to a thematic analysis, and the identification of general themes and theme-clusters.
It is anticipated that a synthesis of results from this and related quantitative investigations into the end of life care needs of patients with COPD will inform the development of a model of palliative care that may best serve this population.
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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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Suzanne Robson
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Address
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Centre for Palliative Care Education & Research
St Vincent's & The University of Melbourne
PO Box 2900
Fitzroy Victoria 3065
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Country
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Australia
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Phone
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+61 3 94160000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Suzanne Robson
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Address
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Centre for Palliative Care Education & Research
St Vincent's & The University of Melbourne
PO Box 2900
Fitzroy Victoria 3065
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Country
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Australia
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Phone
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+61 3 94160000
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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