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Trial registered on ANZCTR


Registration number
ACTRN12619000020189
Ethics application status
Approved
Date submitted
4/01/2019
Date registered
9/01/2019
Date last updated
1/09/2024
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Breathlessness Intervention Service (BLIS) program pilot study
Scientific title
Breathlessness Intervention Services (BLIS) program in people with chronic lung and heart conditions: a pilot study of feasibility, personal, clinical and cost effectiveness.
Secondary ID [1] 296969 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic breathlessness 310930 0
Condition category
Condition code
Respiratory 309594 309594 0 0
Chronic obstructive pulmonary disease
Cardiovascular 309595 309595 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation in a brief intervention based on existing clinical research evidence, directed toward reducing the impact of breathlessness by helping the person to better manage their symptoms. The interventions delivered will not impact on their usual care provided and will be an addition to care once they have been medically and pharmacologically optimised. This brief intervention will involve 2-4 home-based or clinic visits (over the first 4 weeks) from a physiotherapist or nurse and 3-4 telephone contacts (over the next 4 weeks) by the same clinicians. The timing and number of these visits will be flexible within this time frame based on participant need and collaboration between participants and clinician. Visits are anticipated to be conducted in the participant's home unless they have a preference for clinic visits.
The visits will involve comprehensive assessment, collaborative goal setting and therapy using non-drug, symptom management-based therapies that fit the patient’s needs in line with existing evidence (eg Brighton LJ et al Thorax 2018;0:1–12. doi:10.1136/thoraxjnl-2018-211589; Booth S et al Managing breathlessness in clinical practice, Springer Verlag, London 2014) The specific evidence-based therapies that will be delivered help people manage breathlessness by addressing issues related to breathing (examples include hand-held fan, breathing techniques, body position) thinking (action plan for breathlessness, cognitive behavioural therapy strategies; relaxation techniques) and functioning (exercise plan using pedometer; walking aids; activity pacing). The intervention will also include care coordination, facilitation of self-management and integration with all other health and community service providers.
Intervention code [1] 313240 0
Rehabilitation
Intervention code [2] 313241 0
Behaviour
Comparator / control treatment
No control group, this is a feasibility of translation study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318555 0
Program feasibility: composite outcome made up of meeting a priori criteria pre-set with regards to program uptake, participant retention, completion of measures, fidelity of program delivery, and participant experience.
Timepoint [1] 318555 0
Post program, week 9
Secondary outcome [1] 365372 0
Distress due to breathlessness on Multidimensional Dyspnea Profile
Timepoint [1] 365372 0
At post-program (ie 9 weeks), then 3 and 6 months post program, compared with baseline.
Secondary outcome [2] 365373 0
Perceived control of breathlessness using the CRQ-Self Administered Scale (mastery subscale)
Timepoint [2] 365373 0
At post-program (ie 9 weeks), then 3 and 6 months post program, compared with baseline
Secondary outcome [3] 365427 0
Perceived ability to manage or live with breathlessness on NRS scale
Timepoint [3] 365427 0
At post-program (ie 9 weeks), then 3 and 6 months post program, compared with baseline
Secondary outcome [4] 365428 0
Brief Illness Perception Questionnaire
Timepoint [4] 365428 0
At post-program (ie 9 weeks), then 3 and 6 months post program, compared with baseline
Secondary outcome [5] 365429 0
Depression, Anxiety and Stress Scale (DASS21)
Timepoint [5] 365429 0
At post-program (ie 9 weeks), then 3 and 6 months post program, compared with baseline
Secondary outcome [6] 365430 0
Number of days admitted to hospital from SA Health electronic record
Timepoint [6] 365430 0
calculate for the 3 and 6 months before and after program commencement
Secondary outcome [7] 365431 0
Number of emergency department presentations form the SA Health electronic record
Timepoint [7] 365431 0
calculate for the 3 and 6 months before and after program commencement

Eligibility
Key inclusion criteria
At SALHN: Diagnosis of chronic obstructive pulmonary disease (COPD) OR diagnosis of heart failure with chronic respiratory comorbidity (eg COPD / asthma / bronchiectasis / suppurative lung disease / interstitial lung disease). At CAHLN: Diagnosed chronic lung condition.
- Minimum of 1 admission for an acute exacerbation in the past 12 months
- Lives within the SALHN/CALHN demographic area
- Troubled by breathlessness in spite of optimal medical and pharmacological treatment for underlying condition.
-Stable condition (at least 4 weeks after discharge from hospital) at the time commences pilot study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving case management from other existing programs
Patients receiving end-stage Palliative Care Services

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
How will you measure, manipulate and/or analyse the information collected?
The aim of this pilot study is to translate an evidence-based chronic Breathlessness Intervention Service to the Adelaide region and (1) examine the feasibility, acceptability, and participant experience of this program;(2) report on the direction and extent of change in patient and carer reported outcome measures; (3) compare hospital-related health care costs in the 3 and 6 months before and after program participation and estimate cost per quality adjusted life year (QALY) gained from the intervention.
Participant characteristics, feasibility and acceptability data and group information about patient and carer reported outcomes and hospital-related health care utilisation will be descriptively reported and summarised. Non-parametric statistics will be used to examine the direction of changes (ie improvement or deterioration) in pre-post program measures of patient and carer reported outcomes and hospital based health care utilisation. Transcripts of post-program interviews will be examined using content analysis to describe participants feedback on their experiences of and acceptability of the program..


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2019
Actual
13/05/2019
Date of last participant enrolment
Anticipated
4/11/2019
Actual
18/11/2019
Date of last data collection
Anticipated
31/07/2020
Actual
29/07/2020
Sample size
Target
30
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 301537 0
Government body
Name [1] 301537 0
Medical Research Future Fund
Country [1] 301537 0
Australia
Primary sponsor type
Individual
Name
Kylie Johnston
Address
School of Health Sciences, University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 301240 0
None
Name [1] 301240 0
Address [1] 301240 0
Country [1] 301240 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302276 0
Southern Adelaide Clinical HREC
Ethics committee address [1] 302276 0
Ethics committee country [1] 302276 0
Australia
Date submitted for ethics approval [1] 302276 0
Approval date [1] 302276 0
20/11/2018
Ethics approval number [1] 302276 0
HREC/18/SAC/62
Ethics committee name [2] 302277 0
University of South Australia HREC
Ethics committee address [2] 302277 0
Ethics committee country [2] 302277 0
Australia
Date submitted for ethics approval [2] 302277 0
Approval date [2] 302277 0
15/11/2018
Ethics approval number [2] 302277 0
201493

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

Contacts
Principal investigator
Name 89662 0
Dr Kylie Johnston
Address 89662 0
School of Health Sciences, University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 89662 0
Australia
Phone 89662 0
+61 8 8302 2086
Fax 89662 0
Email 89662 0
kylie.johnston@unisa.edu.au
Contact person for public queries
Name 89663 0
Kylie Johnston
Address 89663 0
School of Health Sciences, University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 89663 0
Australia
Phone 89663 0
+61 8 8302 2086
Fax 89663 0
Email 89663 0
kylie.johnston@unisa.edu.au
Contact person for scientific queries
Name 89664 0
Kylie Johnston
Address 89664 0
School of Health Sciences, University of South Australia
GPO Box 2471, Adelaide SA 5001
Country 89664 0
Australia
Phone 89664 0
+61 8 8302 2086
Fax 89664 0
Email 89664 0
kylie.johnston@unisa.edu.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.