Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000018910
Ethics application status
Approved
Date submitted
16/12/2019
Date registered
14/01/2020
Date last updated
3/06/2022
Date data sharing statement initially provided
14/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain and breathlessness in chronic obstructive pulmonary disease (COPD)
Scientific title
The experience of pain and its relationship to dyspnoea in acute exacerbations of chronic obstructive pulmonary disease
Secondary ID [1] 300103 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 315630 0
Condition category
Condition code
Respiratory 313927 313927 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participation in this study will involve the completion of seven short questionnaires, relating to participants' current and past experience of pain and breathlessness. These questionnaires will be completed within 24 hours of admission and take place on the ward to which participants are admitted. Completion of the questionnaires will take approximately 30 minutes.

Based on their responses to the questionnaires, participants may then be asked to participate in a face-to-face interview with research staff, which will take between 30-45 minutes and will be conducted at participants' convenience during their admission in a quiet location on the ward to which they are admitted. They will be asked questions about their experience of pain, and they will be asked to reflect on some of the responses provided in the questionnaires. The interview will be audio-recorded and transcribed. From the participants' medical file, information related to their age, smoking history, social history, past medical history, lung condition and current medical and physiotherapy treatment will be collected.

Participants for this project are being recruited over an 18-month period. However, your participation will be limited to completion of the questionnaires in a single session and one interview (where applicable).
Intervention code [1] 316382 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322320 0
Prevalence of pain, as measured as a ratio of participants responding YES to the prevalence of pain on the Brief Pain Inventory - Short Form, to the total number of participants.
Timepoint [1] 322320 0
In the 24 hours prior to admission to hospital
Primary outcome [2] 322321 0
Presence and location of pain as measured by the Brief Pain Inventory - Short Form
Timepoint [2] 322321 0
In the 24 hours prior to admission to hospital
Primary outcome [3] 322382 0
Intensity of dyspnoea discomfort and dyspnoea qualities as measured by the Multidimensional Dyspnoea Profile
Timepoint [3] 322382 0
Within 24 hours of admission to hospital
Secondary outcome [1] 378078 0
Degree of pain catastrophizing as measured by the Pain Catastrophizing Scale
Timepoint [1] 378078 0
Within 24 hours of admission to hospital
Secondary outcome [2] 378270 0
Degree of breathlessness catastrophizing as measured by the Breathlessness Catastrophizing Scale
Timepoint [2] 378270 0
Within 24 hours of admission to hospital
Secondary outcome [3] 378271 0
Health related quality of life as measured by the COPD Assessement Test
Timepoint [3] 378271 0
Within 24 hours of admission

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion in the study if they have a confirmed diagnosis of an exacerbation of COPD and sufficient English communication skills to respond to questionnaires and participate in an interview. This will be established during the initial screening process.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have a primary diagnosis of a respiratory condition other than COPD including but not limited to bronchiectasis, asthma or interstitial lung disease or if they have been admitted to the high dependency or intensive care units.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Based on result of a previous study in which the prevalence of pain was 39.5% (van Dam van Isselt et al., 2019), with a precision of 5%, a 95% confidence level of 95% and a population size of 226 participants admitted with an acute exacerbation of COPD to the Angliss Hospital annually, a total of 141 participants are required.
Point prevalence will be calculated by the number of participant responses of “Yes” to question 1 of the BPI-SF, as a percentage of the total number of participants. Relationships between variables (pain, dyspnoea, pain catastrophizing, breathlessness catastrophizing, HRQoL) will be explored using either Pearson’s correlation coefficient or Spearman’s rank correlation coefficient, depending on the distribution. The significance of these relationships will be interpreted according to Cohen’s effect size for correlation coefficients. Alpha will be set at <0.05.

Recruitment
Recruitment status
Suspended
Date of first participant enrolment
Anticipated
1/02/2020
Actual
5/02/2020
Date of last participant enrolment
Anticipated
30/07/2021
Actual
16/03/2020
Date of last data collection
Anticipated
30/07/2021
Actual
Sample size
Target
141
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15515 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 28879 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 304547 0
Charities/Societies/Foundations
Name [1] 304547 0
Eastern Health Foundation
Country [1] 304547 0
Australia
Primary sponsor type
Hospital
Name
Angliss Hospital - Eastern Health
Address
39 Albert Street
Upper Ferntree Gully
VIC 3156
Country
Australia
Secondary sponsor category [1] 304824 0
University
Name [1] 304824 0
Monash University - Peninsula Campus
Address [1] 304824 0
Moorooduc Highway
Frankston
VIC 3199
Country [1] 304824 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304974 0
Eastern Health HREC
Ethics committee address [1] 304974 0
5 Arnold Street
Box Hill
VIC 3128
Ethics committee country [1] 304974 0
Australia
Date submitted for ethics approval [1] 304974 0
19/11/2019
Approval date [1] 304974 0
09/12/2019
Ethics approval number [1] 304974 0
LR19/108

Summary
Brief summary
This project is investigating the presence and experience of pain in people admitted to hospital with an acute exacerbation or flare-up of COPD.

Participants will be asked to complete a series of questionnaires, investigating the presence and experience of pain and breathlessness during an exacerbation of COPD. Based on the results of the questionnaires, participants who report experiencing pain will be invited to participate in an interview to further investigate the experience of pain and how they believe that the symptoms of pain and breathlessness interact during acute exacerbations of COPD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98822 0
Mrs Stephanie Clarke
Address 98822 0
Angliss Hospital
39 Albert Street
Upper Ferntree Gully
VIC 3156
Country 98822 0
Australia
Phone 98822 0
+61 03 97646469
Fax 98822 0
Email 98822 0
stephanie.clarke@easternhealth.org.au
Contact person for public queries
Name 98823 0
Mrs Stephanie Clarke
Address 98823 0
Angliss Hospital
39 Albert Street
Upper Ferntree Gully
VIC 3156
Country 98823 0
Australia
Phone 98823 0
+61 03 97646469
Fax 98823 0
Email 98823 0
stephanie.clarke@easternhealth.org.au
Contact person for scientific queries
Name 98824 0
Mrs Stephanie Clarke
Address 98824 0
Angliss Hospital
39 Albert Street
Upper Ferntree Gully
VIC 3156
Country 98824 0
Australia
Phone 98824 0
+61 03 97646469
Fax 98824 0
Email 98824 0
stephanie.clarke@easternhealth.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.