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Trial registered on ANZCTR


Registration number
ACTRN12619001400156
Ethics application status
Approved
Date submitted
6/09/2019
Date registered
14/10/2019
Date last updated
14/10/2019
Date data sharing statement initially provided
14/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Short videos for patients to increase uptake of referral to pulmonary rehabilitation.
Scientific title
Determining the effectiveness of short videos for patients on uptake of referrals to pulmonary rehabilitation: A multi-centre randomised controlled trial.
Secondary ID [1] 299206 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 314316 0
Interstitial lung disease 314687 0
Pulmonary Hypertension 314688 0
Condition category
Condition code
Respiratory 312667 312667 0 0
Chronic obstructive pulmonary disease
Respiratory 313035 313035 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 patient educational videos, informed by behaviour change theory, will be utilised for the intervention. They have a total duration of 12 minutes, and address known barriers to patients attending pulmonary rehabilitation such as lack of understanding about the potential benefits and beliefs about the consequences of attending. The videos feature a respiratory physician, physiotherapist, clinical nurse consultant and a consumer.

Video one involves a respiratory physician discussing the benefits of pulmonary rehabilitation and the patients that are suitable to attend. It also includes a physiotherapist discussing what is involved in an initial assessment. Video two involves a respiratory physician discussing the expected outcomes of attending a pulmonary rehabilitation program, a physiotherapist discussing the exercise prescription and a clinical nurse consultant discussing the importance of taking medications as prescribed. Video three involves a patient discussing her pulmonary rehabilitation experience.

The videos were designed specifically for this study.

This is a pragmatic study - patients will not be supervised whilst watching the videos, nor will there be any video analytics to measure the viewing time. We have chosen this approach because it reflects how the videos are likely to be used in clinical practice if they're shown to be effective.

Materials involved in the intervention are laptops/iPads/desktop computers depending on the availability at the individual site.

All patients who meet the inclusion criteria at the participating hospitals will be randomised using a computer generated randomisation list with permuted blocks of four. Concealed allocation will be achieved using sequentially numbered opaque envelopes stored on each ward. As participants are recruited the next envelope will be opened and the patient will be allocated to either the intervention or control group accordingly. A study register detailing the participant's name, medical record number, group allocation and whether a referral to pulmonary rehabilitation was made will be kept in a secure file on each ward.

The intervention will be delivered by the physiotherapist working on the ward, and will be provided individually at the patients bedspace. Each video will only be viewed once by each patient. The videos will be viewed prior to them agreeing to attend pulmonary rehabilitation.
Intervention code [1] 315504 0
Behaviour
Comparator / control treatment
The control treatment will involve the provision of usual care - verbal patient education about pulmonary rehabilitation and a hospital specific pulmonary rehabilitation brochure. This will be provided by the physiotherapist on the ward, and discussion will be of approximately 5 minutes duration.

As this is a pragmatic study, all patients have a choice as to whether they read the brochure or not. We will not be recording how much they have read.
Control group
Active

Outcomes
Primary outcome [1] 321317 0
Number of participants that attend an initial pulmonary rehabilitation assessment. This will be recorded by the physiotherapist coordinating the pulmonary rehabilitation program in the usual pulmonary rehabilitation patient database. This database is maintained by the physiotherapists and is routinely collected data.
Timepoint [1] 321317 0
Collected at the time of contact by the pulmonary rehabilitation service at each hospital - this time will vary depending on the site's waiting list. Given the waiting list for pulmonary rehabilitation varies between sites, this data will be collected between one week and six months after viewing the videos.
Secondary outcome [1] 374616 0
Number of patients consenting to referral to pulmonary rehabilitation. A ward based study data collection sheet will be kept to record the number of patients that consent to referral to pulmonary rehabilitation, and the number that decline referral.
Timepoint [1] 374616 0
Immediately post delivering either the intervention or control.
Secondary outcome [2] 374617 0
Pulmonary rehabilitation completion rate (>70% of classes attended with one post program outcome measure reassessed). This will be recorded by the physiotherapist coordinating the pulmonary rehabilitation program in the usual pulmonary rehabilitation patient database. This database is maintained by the physiotherapists and is routinely collected data.
Timepoint [2] 374617 0
Collected at the time of discharge from the pulmonary rehabilitation program. This will vary depending on the waiting list at each participating site, but will be between 8 weeks to 9 months after receiving the intervention.
Secondary outcome [3] 374618 0
COPD Assessment Test
Timepoint [3] 374618 0
Collected at the time of discharge from the pulmonary rehabilitation program. This will vary depending on the waiting list at each participating site, but will be between 8 weeks to 9 months after receiving the intervention.
Secondary outcome [4] 375487 0
Six minute walk test
Timepoint [4] 375487 0
Collected at the time of discharge from the pulmonary rehabilitation program. This will vary depending on the waiting list at each participating site, but will be between 8 weeks to 9 months after receiving the intervention.
Secondary outcome [5] 375488 0
5 x repeated sit to stand test
Timepoint [5] 375488 0
Collected at the time of discharge from the pulmonary rehabilitation program. This will vary depending on the waiting list at each participating site, but will be between 8 weeks to 9 months after receiving the intervention.
Secondary outcome [6] 375489 0
St George Respiratory Questionnaire
Timepoint [6] 375489 0
Collected at the time of discharge from the pulmonary rehabilitation program. This will vary depending on the waiting list at each participating site, but will be between 8 weeks to 9 months after receiving the intervention.
Secondary outcome [7] 375490 0
Hospital Anxiety and Depression Scale
Timepoint [7] 375490 0
Collected at the time of discharge from the pulmonary rehabilitation program. This will vary depending on the waiting list at each participating site, but will be between 8 weeks to 9 months after receiving the intervention.

Eligibility
Key inclusion criteria
Patients admitted to the participating ward with a respiratory cause for admission, who meet the criteria for referral to pulmonary rehabilitation. This includes patients with a diagnosis of chronic obstructive pulmonary disease, interstitial lung disease, chronic asthma and pulmonary hypertension.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients currently participating in a pulmonary rehabilitation program.
Patients unable to understand basic spoken English.
Severe cognitive impairment.
Contraindications to exercise such as unstable cardiovascular disease

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allocation will be achieved using sequentially numbered opaque envelopes stored in each ward. As participants are recruited the next envelope will be opened and the patient will be allocated to either the intervention or control group accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation list will be used, with permuted blocks of four.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size was based on data collected from a pilot study. Assuming an increased in pulmonary rehabilitation referral from 24% to 40%, and an increase in uptake from 10% to 20% in the intervention group, then a total of 340 patients are required, with 80% power and alpha 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/09/2019
Date of last participant enrolment
Anticipated
31/08/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
340
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14734 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 14735 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 14736 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 14737 0
Canterbury Hospital - Campsie
Recruitment hospital [5] 14738 0
Fairfield Hospital - Prairiewood
Recruitment hospital [6] 14739 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 27776 0
2031 - Randwick
Recruitment postcode(s) [2] 27777 0
2229 - Caringbah
Recruitment postcode(s) [3] 27778 0
2050 - Camperdown
Recruitment postcode(s) [4] 27779 0
2194 - Campsie
Recruitment postcode(s) [5] 27780 0
2176 - Prairiewood
Recruitment postcode(s) [6] 27781 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 303749 0
Government body
Name [1] 303749 0
Agency For Clinical Innovation
Country [1] 303749 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Cnr Elizabeth and Goulburn Streets, Liverpool, NSW, 2170
Country
Australia
Secondary sponsor category [1] 303869 0
None
Name [1] 303869 0
Address [1] 303869 0
Country [1] 303869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304269 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304269 0
Ethics committee country [1] 304269 0
Australia
Date submitted for ethics approval [1] 304269 0
01/05/2019
Approval date [1] 304269 0
17/05/2019
Ethics approval number [1] 304269 0

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

Contacts
Principal investigator
Name 96354 0
Ms Zoe Elizabeth Colman
Address 96354 0
Physiotherapy Department,
Level 2 Health Services Building,
Liverpool Hospital,
Corner Campbell and Goulburn Street
Liverpool, NSW 2170
Country 96354 0
Australia
Phone 96354 0
+61 02 8738 4703
Fax 96354 0
Email 96354 0
Zoe.Colman@health.nsw.gov.au
Contact person for public queries
Name 96355 0
Zoe Elizabeth Colman
Address 96355 0
Physiotherapy Department,
Level 2 Health Services Building,
Liverpool Hospital,
Corner Campbell and Goulburn Street
Liverpool, NSW 2170
Country 96355 0
Australia
Phone 96355 0
+61 02 8738 4703
Fax 96355 0
Email 96355 0
Zoe.Colman@health.nsw.gov.au
Contact person for scientific queries
Name 96356 0
Zoe Elizabeth Colman
Address 96356 0
Physiotherapy Department,
Level 2 Health Services Building,
Liverpool Hospital,
Corner Campbell and Goulburn Street
Liverpool, NSW 2170
Country 96356 0
Australia
Phone 96356 0
+61 02 8738 4703
Fax 96356 0
Email 96356 0
Zoe.Colman@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified baseline and outcome data will be available from the researchers on request.
When will data be available (start and end dates)?
It will be available for 7 years after publication of the study, as required by the approving ethics committee.
Available to whom?
Researchers on request.
Available for what types of analyses?
For potential inclusion in a systematic review.
How or where can data be obtained?
Emailing the prinicipal investigator zoe.colman@health.nsw.gov.au or supervising investigator sarah.dennis@sydney.edu.au


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.