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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)
Scientific title
A qualitative exploration of the needs of patients with severe chronic obstructive pulmonary disease (COPD)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease (COPD) 3952 0
Condition category
Condition code
Respiratory 4145 4145 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
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.
Intervention code [1] 3666 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5039 0
(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.
Timepoint [1] 5039 0
This will be observed/measured by a one-off semi-structured interview
Primary outcome [2] 5040 0
(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.
Timepoint [2] 5040 0
This will be observed/measured by a one-off semi-structured interview
Primary outcome [3] 5041 0
(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.
Timepoint [3] 5041 0
This will be observed/measured by a one-off semi-structured interview or focus group
Secondary outcome [1] 8802 0
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
Timepoint [1] 8802 0
This will be observed/measured by a one-off semi-structured interview or focus group

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non english speaking

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4131 0
Charities/Societies/Foundations
Name [1] 4131 0
Bethlehem Griffiths Research Foundation
Address [1] 4131 0
476 Kooyong Road, Caulfield, VIC 3162
Country [1] 4131 0
Australia
Primary sponsor type
University
Name
Centre for Palliative Care Education and Research
Address
St Vincent's & The University of Melbourne
PO Box 2900
Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 3716 0
None
Name [1] 3716 0
Address [1] 3716 0
Country [1] 3716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6201 0
The Alfred Hospital Research and Ethics Comittee
Ethics committee address [1] 6201 0
The Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Ethics committee country [1] 6201 0
Australia
Date submitted for ethics approval [1] 6201 0
Approval date [1] 6201 0
29/07/2008
Ethics approval number [1] 6201 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29109 0
Address 29109 0
Country 29109 0
Phone 29109 0
Fax 29109 0
Email 29109 0
Contact person for public queries
Name 12266 0
Suzanne Robson
Address 12266 0
Centre for Palliative Care Education & Research
St Vincent's & The University of Melbourne
PO Box 2900
Fitzroy Victoria 3065
Country 12266 0
Australia
Phone 12266 0
+61 3 94160000
Fax 12266 0
Email 12266 0
suzanne.robson@svhm.org.au
Contact person for scientific queries
Name 3194 0
Suzanne Robson
Address 3194 0
Centre for Palliative Care Education & Research
St Vincent's & The University of Melbourne
PO Box 2900
Fitzroy Victoria 3065
Country 3194 0
Australia
Phone 3194 0
+61 3 94160000
Fax 3194 0
Email 3194 0
suzanne.robson@svhm.org.au

No data has been provided for results reporting
Summary results
Not applicable