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Trial registered on ANZCTR


Registration number
ACTRN12619001122145
Ethics application status
Approved
Date submitted
1/07/2019
Date registered
12/08/2019
Date last updated
12/08/2019
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Early home-based pulmonary rehabilitation after hospitalisation in chronic obstructive pulmonary disease (COPD)
Scientific title
The effect of early home-based pulmonary rehabilitation after hospitalisation on hospital readmission in chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 298393 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 313084 0
Condition category
Condition code
Respiratory 311570 311570 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People who agree to take part in the study will be randomly allocated to undertake pulmonary rehabilitation at home (early HomeBase)(commenced within 2 weeks of hospital discharge) or usual post-hospital care. People allocated to undertake early home-based pulmonary rehabilitation (n=83) will receive, in addition to standard (usual) care, an initial home visit from a physiotherapist to establish the exercise training program, facilitate setting of exercise goals and to ensure safety. This will be followed by seven once-weekly phone consultations with a physiotherapist, specially trained in motivational interviewing, to undertake self-management training and promote exercise progression. The total program duration is 8-weeks.

The home-based exercise training program will consist of a walking program (including use of a pedometer) and light weights for the arms and legs using readily available equipment in the home (eg. water bottles). Participants will be encouraged to undertake exercise on at least 5 days in the week, and to record their exercise participation in a home exercise diary. The overall goal of the program is for participants to work towards achieving at least thirty minutes of aerobic training on most days of the week. Exercise training intensity and session duration will be individualised and guided by participants perceived breathlessness (e.g BORG breathlessness scale, range 3-4). Home exercise diaries will be reviewed during the weekly telephone call consultation with the physiotherapist.

All participants will receive standard (usual) care, including medical management for their exacerbation based on COPD-X guidelines (which may include inhaled bronchodilators, systemic glucocorticoids and antibiotic therapy as indicated, controlled oxygen therapy and ventilatory assistance as required) and physiotherapy, commencing on the first day of admission. In line with guideline recommendations for management of an acute exacerbation of COPD, standard (usual) care may include referral to traditional outpatient (centre-based) pulmonary rehabilitation after discharge from hospital.

Participants randomised to the intervention (early HomeBase) group will be precluded from attending outpatient pulmonary rehabiliation during the intervention period (ie. Weeks 0-10 post hospital discharge). This is to prevent participants undertaking two pulmonary rehabilitation programs at the same time (home and centre-based). Participants in the intervention group will not be precluded from referral to or attending outpatient pulmonary rehabilitation at any time during the 12 month followup period.

At the beginning and end of the 8 weeks of the intervention phase, and after 12-months followup, participants will undergo measurements of functional capacity and health status. Hospital medical records and GP records will be reviewed to determine the need and frequency of hospital admissions. This will be tracked for 12 months for all participants.
Intervention code [1] 314636 0
Treatment: Other
Intervention code [2] 314637 0
Rehabilitation
Comparator / control treatment
All participants will receive standard (usual) care, including medical management for their exacerbation based on COPD-X guidelines (which may include inhaled bronchodilators, systemic glucocorticoids and antibiotic therapy as indicated, controlled oxygen therapy and ventilatory assistance as required) and physiotherapy, commencing on the first day of admission. In line with guideline recommendations for management of an acute exacerbation of COPD, standard (usual) care may include referral to traditional outpatient (centre-based) pulmonary rehabilitation after discharge from hospital.

In addition to standard care, participants randomised to the standard (usual) care control group will also receive a weekly telephone call for the period of the intervention (8 weeks), provided by a researcher not experienced in pulmonary rehabilitation. Telephone calls will not include any health information or advice on physical activity or exercise and are designed to serve as attention control. Specifically, control group participants will be asked about their general health status, and if they have needed to attend their GP or the hospital emergency department in the preceding week.

At the beginning and end of the 8 weeks of the intervention phase, and after 12-months followup, participants will undergo measurements of exercise capacity and health status. Hospital medical records and GP records will be reviewed to determine the need and frequency of hospital admissions. This will be tracked for 12 months for all participants.
Control group
Active

Outcomes
Primary outcome [1] 320301 0
Hospital readmission (all cause) - from hospital medical record review.
Timepoint [1] 320301 0
From end of intervention (T1) to 12 months followup (T2) (data collection to take place at 12 months)
Secondary outcome [1] 371105 0
Change in functional capacity assessed by the 1 minute sit to stand test (number of repetitions)
Timepoint [1] 371105 0
Baseline (T0)
End of intervention (T1 ie. week 9)
12 months followup (T2)
Secondary outcome [2] 371106 0
Change in health-related quality of life will be measured using two instruments:
- Chronic Respiratory Disease Questionnaire; and,
- EQ-5D-5L
Timepoint [2] 371106 0
Baseline (T0)
End intervention (T1 ie. week 9)
12 months followup (T2)
Secondary outcome [3] 371107 0
Change in Hospital Anxiety and Depression Scale
Timepoint [3] 371107 0
Baseline (T0)
End intervention (T1 ie. week 9)
12 months followup (T2)
Secondary outcome [4] 371108 0
Change in self efficacy will be measured using the Pulmonary Rehabilitation Adapted Index of Self Efficacy (PRAISE) tool
Timepoint [4] 371108 0
Baseline (T0)
End intervention (T1 ie. week 9)
12 months followup (T2)
Secondary outcome [5] 371109 0
Change in perception of health status using the Modifed Medical Research Council Dyspnoea Scale (mMRC)
Timepoint [5] 371109 0
Baseline (T0)
End intervention (T1 ie. week 9)
12 months followup (T2)
Secondary outcome [6] 371110 0
Change in physical activity participation - objectively measured via accelerometery
Timepoint [6] 371110 0
Baseline (T0)
End intervention (T1 ie. week 9)
12 months followup (T2)
Secondary outcome [7] 373746 0
Healthcare costs will be assessed from healthcare utilisation data collected from the medical record and MBS/PBS data
Timepoint [7] 373746 0
From end intervention (T1 ie. week 9) to 12 months followup (T2) (data collection to take place at 12 months followup)

Eligibility
Key inclusion criteria
- Have a diagnosis of COPD
- Be admitted to hospital for an acute exacerbation of their COPD
- Aged 40 years and older
- Able to read and speak English
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Life expectancy less than 6 months
- Comorbidities which preclude exercise training
- Inability to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
- Unable to provide informed consent

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)
Central allocation by phone/fax/computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with stratification for:
i) disease severity (forced expiratory volume in one second (FEV1) greater than or equal to 50%predicted vs less than 50%predicted)
(ii) age (greater than or equal to 75 years vs less than 75 years)
(iii) site of recruitment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To detect a difference in hospital readmission between the intervention group (early HomeBase pulmonary rehabilitation) and standard (usual) care control group at 12-months following the intervention period, a total of 132 participants (66 participants in each group) will be required to detect a reduction in readmission rate to 30% with 80% power and a significance level of p<0.05. This assumes a rate of readmission of 57% in the standard (usual) care group. An additional 34 participants will be recruited to allow for 20% dropout. This is a conservative estimate for attrition, with our previous studies of home-based pulmonary rehabilitation demonstrating around 15% dropout rate; we will therefore randomise a total of 166 participants.

Analysis will use intention-to-treat principles, with inclusion of all participants regardless of program completion. For the primary hypothesis (readmission), the relative risk in the intervention group compared to control group will be reported with a 95% confidence interval. Secondary continuous outcomes will be examined using linear mixed models. A per protocol analysis will be undertaken including those who complete the program (greater than or equal to 70% of sessions attended). We will explore time to readmission using Cox regression.

Recruitment
Recruitment status
Not yet 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)
NSW,VIC
Recruitment hospital [1] 13900 0
The Alfred - Prahran
Recruitment hospital [2] 13901 0
Wimmera Health Care Group - Horsham - Horsham
Recruitment hospital [3] 13902 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 13903 0
Prince of Wales Hospital - Randwick
Recruitment hospital [5] 13904 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment postcode(s) [1] 26673 0
3004 - Prahran
Recruitment postcode(s) [2] 26674 0
3400 - Horsham
Recruitment postcode(s) [3] 26675 0
2050 - Camperdown
Recruitment postcode(s) [4] 26676 0
2031 - Randwick
Recruitment postcode(s) [5] 26677 0
2450 - Coffs Harbour

Funding & Sponsors
Funding source category [1] 302935 0
Government body
Name [1] 302935 0
National Health and Medical Research Council
Address [1] 302935 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 302935 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Level 4, The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 302896 0
None
Name [1] 302896 0
Address [1] 302896 0
Country [1] 302896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303497 0
Alfred Health HREC
Ethics committee address [1] 303497 0
Ethics and Research Governance
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 303497 0
Australia
Date submitted for ethics approval [1] 303497 0
06/03/2019
Approval date [1] 303497 0
04/04/2019
Ethics approval number [1] 303497 0
51216

Summary
Brief summary
After a period of hospitalisation, pulmonary rehabilitation can improve symptoms and function and reduce healthcare costs in people with chronic obstructive pulmonary disease (COPD). Yet less than 10% of people with COPD access pulmonary rehabilitation after a hospital stay.
This multi-site randomised controlled trial will examine the benefits and costs of home-based pulmonary rehabilitation undertaken immediately following hospitalisation, compared to usual care, for people with COPD. It is hypothesised that Early HomeBase pulmonary rehabilitation will reduce hospital readmissions, and provide clinically significant improvements in exercise capacity and health-related quality of life, which are greater than those seen in the usual care group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93866 0
Dr Narelle Cox
Address 93866 0
La Trobe University
Level 4, The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 93866 0
Australia
Phone 93866 0
+61394976871
Fax 93866 0
+61395332104
Email 93866 0
n.cox@latrobe.edu.au
Contact person for public queries
Name 93867 0
Dr Narelle Cox
Address 93867 0
La Trobe University
Level 4, The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 93867 0
Australia
Phone 93867 0
+61394976871
Fax 93867 0
+61395332104
Email 93867 0
n.cox@latrobe.edu.au
Contact person for scientific queries
Name 93868 0
Dr Narelle Cox
Address 93868 0
La Trobe University
Level 4, The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country 93868 0
Australia
Phone 93868 0
+61394976871
Fax 93868 0
+61395332104
Email 93868 0
n.cox@latrobe.edu.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?
Individual participant data can be shared once approval has been obtained from the
relevant Human Research Ethics Committee.
When will data be available (start and end dates)?
Data will not be available prior to publication of the main trial results. There is no specific end date until which data will be available.
Available to whom?
Data will be available on a case by case basis, at the discretion of the Coordinating Principal Investigator and after protocol review and approval of the relevant Human Research Ethics Committees.
Available for what types of analyses?
Data will be available for analyses that are approved by the relevant Human Research Ethics Committees.
How or where can data be obtained?
Access to data will be subject to approval by the Coordinating Principal Investigator (email request to n.cox@latrobe.edu.au) and approval by the Alfred Health Human Research Ethics Committee. Individuals requesting data will also need to apply to the Alfred Health HREC specifying their intended use of the data. Data will only be released once all relevant approvals have been obtained.
What supporting documents are/will be available?
No other documents available
Summary results
No Results