Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000292976
Ethics application status
Approved
Date submitted
17/03/2011
Date registered
21/03/2011
Date last updated
19/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Can changing the way people with chronic lung disease think about breathlessness improve and sustain health outcomes?
Scientific title
In people with chronic obstructive pulmonary disease (COPD) does pulmonary rehabilitation combined with a cognitive behavioural therapy program for the sensation of breathlessness (BREVE) compared to pulmonary rehabilitation alone improve anxiety and functional exercise capacity at one, six and twelve months
Secondary ID [1] 259821 0
None
Universal Trial Number (UTN)
Trial acronym
BREVE RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breathlessness 261060 0
Condition category
Condition code
Respiratory 259205 259205 0 0
Chronic obstructive pulmonary disease
Public Health 265555 265555 0 0
Health promotion/education
Physical Medicine / Rehabilitation 265556 265556 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eight week comprehensive pulmonary rehabilitation (CPR) with a cognitive behavioural therapy program for the sensation of breathlessness (CPR + BREVE). The pulmonary rehabilitation program adheres to the recommendations of the COPD-X Plan 2008, and includes three exercise sessions (circuit training group therapy) and a two-hour education session each week (group therapy). The eight week CBT program (BREVE –Breathless. Recognise sensations, Explore thoughts and beliefs, Validate whether thoughts are useful or harmful, Evolve and change behaviour) includes one hour group work facilitated by a psychologist supported by an eight module workbook. Each module includes an educational component, individual reflective activity, practice tasks for the exercise sessions and homework.

Interventions and control occur seperately (i.e cycles of pulmonary rehabilation with and without the active intervention occur in randomised sequence)
Intervention code [1] 257941 0
Rehabilitation
Intervention code [2] 264248 0
Treatment: Other
Intervention code [3] 264249 0
Behaviour
Comparator / control treatment
Eight week comprehensive pulmonary rehabilitation (CPR). The pulmonary rehabilitation program adheres to the recommendations of the COPD-X Plan 2008, and includes three exercise sessions (circuit training) and a two-hour education session each week.
Control group
Active

Outcomes
Primary outcome [1] 262050 0
The six minute walk test (6MWT) assesses function exercise capacity (metres walked during six minutes)
Timepoint [1] 262050 0
Baseline (one month prior to intervention), one, six and twelve months after completion of intervention
Primary outcome [2] 262051 0
The Hospital Anxiety and Depression Scale (HADS)
Timepoint [2] 262051 0
Baseline (one month prior to intervention), one, six and twelve months after completion of intervention
Secondary outcome [1] 273030 0
The sensation of dyspnoea assessed via structured interview which includes, volunteered and endorsed descriptors and 10cm visual analogue scales for intensity and unpleasantness (anchored between 0 = no breathlessness / not unpleasant at all and 10cm = worse possible breathlessness / worst unpleasantness imaginable) .
Timepoint [1] 273030 0
Assessed at rest and immediately following the six minute walk test (6MWT) at timepoints, baseline (one month prior to intervention), one, six and twelve months after completion of intervention
Secondary outcome [2] 273031 0
The Chronic Respiratory Questionnaire (CRQ) -a self-administered respiratory related quality of life questionnaire with four domains: dyspnoea, fatigue, emotional function and mastery.
Timepoint [2] 273031 0
Baseline (one month prior to intervention), one, six and twelve months after completion of intervention
Secondary outcome [3] 273032 0
Frequency of exacerbations and Health care usage. An exacerbation of COPD is defined as a change in self perceived symptomology necessitating a change of management classified as mild (increase in usual therapy), moderate (addition of steroids, antibiotics or both) or severe (requiring hospital attendance). Participants will keep a daily symptom diary including planned and unplanned attendance at health care providers.
Timepoint [3] 273032 0
Monthly for twelve months following completion of intervention
Secondary outcome [4] 273133 0
Accelerometery using the Actigraph GT1X3e to assess participants physical activity (minutes spent in moderate to vigorous physical activity, sedentary behaviours).
Timepoint [4] 273133 0
Baseline (one month prior to intervention), one, six and twelve months after completion of intervention
Secondary outcome [5] 273134 0
Use of time using the Multimedia Activity Recall for Children and Adults (MARCA) -a computer-assisted 24-hour recall instrument that adopts a time-diary approach asking respondents to recall their previous day in pre determined time slice
Timepoint [5] 273134 0
Baseline (one month prior to intervention), one, six and twelve months afer completion of intervention

Eligibility
Key inclusion criteria
People referred to Repatriation General Hospital to undertake the Comprehensive Pulmonary Rehabilitation (CPR) program will be eligible for inclusion in this study if they have a clinical diagnosis of COPD, intend to undertake the eight week CPR and have a forced expiratory volume (FEV1) < 80 percent predicted and best recorded ratio of FEV1 to forced vital capacity of < 70 percent (FEV1/FVC <70%).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be only be excluded from this RCT due to the presence of cognitive or memory impairments (Mini-Mental State Examination score < 23/30), have clinically unstable COPD or co-morbidities which are likely to render exercise unsafe (determined by respiratory physician based upon change in medication or symptoms over the past two months) or are currently registered for lung volume reduction surgery or lung transplantation (risk of withdrawal from RCT).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The staff of the CPR program will retain responsibility for receiving patient referrals, scheduling appointments for CPR and posting materials for the CPR program including an information sheet outlining this RCT. On attending the first assessment for CPR, the project officer will meet each potential participant to provide information, clarification and invite participation in the study prior to requesting written consent. The process of randomisation will be clearly conveyed. That is that in accepting the invitation to participate in this study, participants will attend one additional session per week which will provide an opportunity either to socialise with their group or to practice changing the way they think about breathlessness. The intervention offered is predetermined and will not be known by the project officer . The participant will only know which intervention has been allocated after the baseline assessments are completed. Potential participants will not be able to choose the intervention. Regardless of which group the participant is allocated to, all participants will receive the same CPR. Intervention and schedule will be provided to the participant in sealed envelop.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pre-determined concealed, block randomisation using random numbers tables . Cycles of pulmonary rehabilitation (8 weeks each) are randomised to either intervention rather than individuals being randomised to intervention or control within each eight week block of pulmonary rehabilitation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2011
Actual
9/05/2011
Date of last participant enrolment
Anticipated
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264685 0
Government body
Name [1] 264685 0
NHMRC
Country [1] 264685 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Heath Sciences
City East Campus
North Terrace
Adelaide 5000
Country
Australia
Secondary sponsor category [1] 263818 0
None
Name [1] 263818 0
Address [1] 263818 0
Country [1] 263818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266678 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 266678 0
Ethics committee country [1] 266678 0
Australia
Date submitted for ethics approval [1] 266678 0
Approval date [1] 266678 0
05/01/2011
Ethics approval number [1] 266678 0
P153/07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32151 0
Dr Marie T Williams
Address 32151 0
School of Population Health Division of Health Sciences, University of South Australia, P4-27D Playford Building, City East Campus, Internal Post Code CEA-09
Country 32151 0
Australia
Phone 32151 0
+61 8 8302 1153
Fax 32151 0
Email 32151 0
[email protected]
Contact person for public queries
Name 15398 0
Dr Marie Williams
Address 15398 0
Associate Head, School of Population Health Division of Health Sciences, University of South Australia, P4-27D Playford Building, City East Campus, Internal Post Code CEA-09
Country 15398 0
Australia
Phone 15398 0
+61 8 8302 1153
Fax 15398 0
+61 8 8302 2794
Email 15398 0
[email protected]
Contact person for scientific queries
Name 6326 0
Dr Marie Williams
Address 6326 0
Associate Head, School of Population Health, Division of Health Sciences,University of South Australia,P4-27D Playford Building, City East Campus, Internal Post Code CEA-09
Country 6326 0
Australia
Phone 6326 0
+61 8 8302 1153
Fax 6326 0
+61 8 8302 2794
Email 6326 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
SourceTitleYear of PublicationDOI
EmbaseComparison of the Dyspnoea-12 and Multidimensional Dyspnoea Profile in people with COPD.2017https://dx.doi.org/10.1183/13993003.00773-2016
EmbaseUse of time in chronic obstructive pulmonary disease: Longitudinal associations with symptoms and quality of life using a compositional analysis approach.2019https://dx.doi.org/10.1371/journal.pone.0214058
N.B. These documents automatically identified may not have been verified by the study sponsor.