The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000952347p
Ethics application status
Not yet submitted
Date submitted
22/06/2017
Date registered
4/07/2017
Date last updated
4/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a 'take charge' intervention reduce incidence of repeat acute exacerbation of chronic obstructive pulmonary disease? A feasibility study
Scientific title
Can a 'take charge' intervention reduce incidence of repeat acute exacerbation of chronic obstructive pulmonary disease? A feasibility study
Secondary ID [1] 292246 0
None.
Universal Trial Number (UTN)
U1111-1198-1955
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 303749 0
Condition category
Condition code
Respiratory 303122 303122 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experimental intervention is a "Take Charge Session" (TCS). This intervention is delivered to people in their homes following hospitalisation for an acute exacerbation of chronic obstructive pulmonary disease (COPD). A single 90-minute TCS to be conducted with the participants and their families within two weeks of discharge from hospital. This TCS will be manualised (i.e. follow a process outlined in a ‘Take Charge’ manual) and involve the following:
• A trained lay research assistant will be allocated to each participant, matching for ethnicity as much as possible i.e. Maori research assistants will be allocated to Maori participants; Pacific Island research assistants will be allocated to Pacific Island participants.
• The participant will be given the ‘Taking Charge’ manual, which they can keep and use to develop their own personal health programme.
• The research assistant will conduct an individualised assessment with a structured risk factors and activity of daily living assessment designed to engage the patients and their family in the process of recovery. This will involve a process where they identify for themselves areas where they could make progress and set personal goals, i.e. self-directed rehabilitation. This assessment will be documented in the participant’s manual, and will use the following main headings: physical, emotional/mood, information needs, financial, family, work (paid and unpaid), and secondary prevention. However, participants will be able to add to these if other areas of personal development are identified.
• The research assistant will guide the participant and their family to identify and document goals under each heading where relevant, which they can add to over time as they choose.
• The participant and their family will then be encouraged to consider intermediate steps to the goals and how long it might take to achieve these. They will then be encouraged to think about ways of making these steps happen.
Following this process, the participants and their family will be introduced to pulmonary rehabilitation. While the term ‘pulmonary rehabilitation’ will be acknowledged, the word ‘rehabilitation’ will initially be avoided as it is potentially perceived as stigmatising (most often related in popular culture to drug & alcohol dependency). Instead, PR will be referred to as a ‘health and wellbeing class for people with lung problems’. Information sheets about pulmonary will be specifically tailored for Maori, Pacific Island, and non-Maori/non-Pacific participants. These information sheets will be presented primarily in English, but will include terminology and concepts specific to Maori and Pacific Island participants to make it clear how PR relates to people from these cultures (e.g. addressing the ‘kaupapa’ of pulmonary rehabilitation for Maori participants).
Throughout the TCS the participants and their families will be encouraged to ‘take charge’ of their recovery process, having seen for themselves where the key issues are and giving them basic skills and support to write a self-directed rehabilitation plan for themselves. The TCS manual will be retained by the person with COPD, to be used as they see fit, and they will not be required to share it with any health professionals.
The research assistants delivering the intervention will complete a five day training programme prior to starting the study and receive ongoing training during the study. This training will include information about COPD and its management, but will also address issues of language use (avoiding stigmatisation of COPD), facilitating open discussion, increasing participant self-worth, and empowering participants to feel capable of achieving goals they set out to pursue.
As this is a feasibility study (prior to a fully powered clinical trial) development of methods for evaluating intervention fidelity is one of the objectives of this trial. To do this we will undertake semi-structured interviews with all research assistants providing the TCS three months after they have received training in the intervention. These interviews will likewise be analysed using qualitative descriptive analysis and constant comparative methods, and will focus on the research assistants’ experience of the training and implementation of the behavioural intervention. To evaluate intervention fidelity we will video-record 12 episodes of the TCS being implemented with people from a range of different ethnicities, and compared these to a checklist of expected standards for implementation of the intervention. We will use both the interview and video data to refine and improve the training and support we provide the research assistants in the full study. Evaluation of treatment fidelity will be managed by the primary investigator (William Levack).
Intervention code [1] 298414 0
Rehabilitation
Comparator / control treatment
The control group will receive ‘usual care’ for COPD after hospital discharge, plus a pamphlet about COPD with general information about management of common problems. Participants in both the intervention and control group will receive onwards referral to pulmonary rehabilitation, with an offer of enrolling in pulmonary rehabilitation within two months of discharge from hospital. Referral to pulmonary rehabilitation will follow usual practice at the research locality (Capital & Coast District Health Board, Wellington, New Zealand), which includes referral of all Maori and Pacific Island participants to Whanau Care and Pacific Health Services to facilitate transport and social support for access to pulmonary rehabilitation classes.
Control group
Active

Outcomes
Primary outcome [1] 302509 0
Frequency of moderate to severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD). We will classify moderate AECOPD as those requiring treatment with oral corticosteroids or antibiotics and severe AECOPD as those requiring admission to hospital. We will collect data on prescription of oral corticosteroids and antibiotics from hospital, emergency department (ED), and general practice records.
Timepoint [1] 302509 0
Within 12 months of the index hospital admission.
Secondary outcome [1] 336261 0
Short-Form 36 Physical
Timepoint [1] 336261 0
At 3 months and 12 months following the index admission.
Secondary outcome [2] 336265 0
Short-Form 36 Mental
Timepoint [2] 336265 0
At 3 months and 12 months following the index admission.
Secondary outcome [3] 336266 0
Clinical COPD Questionnaire
Timepoint [3] 336266 0
At 3 months and 12 months following the index admission.
Secondary outcome [4] 336267 0
Hospital Anxiety and Depression Scale. Rasch analysis has demonstrated that this is a unidimensional measure of psychological distress (Pallant and Tennant. (2007) Br J Clin Psychol. 46:1-18.), i.e. it is a composite secondary outcome.
Timepoint [4] 336267 0
At 3 months and 12 months following the index admission.
Secondary outcome [5] 336268 0
Patient Activation Questionnaire
Timepoint [5] 336268 0
At 3 months and 12 months following the index admission.
Secondary outcome [6] 336269 0
Mortality rates.
Timepoint [6] 336269 0
Within first 12 months of index admission.
Secondary outcome [7] 336270 0
Smoking status by self-report. We will use the NZ 2013 Census questions on smoking to categorise people as either: 1) regular smoker; 2) ex-smoker; or 3) never smoked regularly.
Timepoint [7] 336270 0
At 3 months and 12 months following the index admission.
Secondary outcome [8] 336271 0
Hospitalisation rates. These will be based on hospital records at Capital & Coast DHB (the location of the index admission required for entry into the study). We will match the participants' National Health Index numbers to their hospital records to count the number of hospital admissions over the 12 months following the index admission. We will ask the participants about any hospital admissions they can remember as a minor check of the quality of this hospital record data and to estimate the number of hospital admission that might occur in other DHBs. However, we will only count hospital admissions that can be verified by patient records.
Timepoint [8] 336271 0
Within 12 months of index admission.
Secondary outcome [9] 336272 0
Admission to pulmonary rehabilitation. We will gather this information directly from the community services running the pulmonary rehabilitation programmes. An 'admission' will be counted as such if the participant turned up to their first pulmonary rehabilitation session within 6 months of the index admission.
Timepoint [9] 336272 0
Within 6 months of index admission.
Secondary outcome [10] 336273 0
Completion of pulmonary rehabilitation, classified as 'yes' or 'no' on the basis of attending or not attending 70% or more of prescribed sessions. We will gather this information directly from the community services running the pulmonary rehabilitation programmes.
Timepoint [10] 336273 0
Within 6 months of index admission.
Secondary outcome [11] 336345 0
Qualitative experience of participants. We will collect and analysis data qualitatively, using semi-structured interviews, on participants' experiences and perspectives of receiving the intervention. This will include qualitative examination of perceived acceptability and cultural appropriateness of the intervention. As acceptability and cultural appropriateness are interrelated qualitative issues, we will treat them as a composite secondary outcome.
Timepoint [11] 336345 0
3 months.
Secondary outcome [12] 336346 0
Cost of the "Take Charge" and control intervention. We will keep detailed descriptive accounts of all costs associated with implementation of the "Take Charge" and control interventions. This will include training, transport, personnel, equipment, participant reimbursement, and printing costs. We will use this data to inform development of options for economic analyses in a future full study.
Timepoint [12] 336346 0
3 months
Secondary outcome [13] 336347 0
Qualitative experiences of personnel. We will collect and analysis data qualitatively, using semi-structured interviews, on the research personnel's experience of the suitability of the training and support for
delivering the "Take Charge" intervention, to inform a future fully powered RCT.
Timepoint [13] 336347 0
3 months after initial training of the personnel
Secondary outcome [14] 336348 0
Testing of intervention fidelity. We will evaluate intervention fidelity qualitatively by video-recording 12 episodes of the "Take Charge" session being implemented with people from a range of different ethnicities, and compare these to a checklist of basic expected standards for implementation of the intervention. We will use both the interview and video data to refine and improve the training and support we provide the research assistants in the future full study.
Timepoint [14] 336348 0
6 months

Eligibility
Key inclusion criteria
People admitted to Capital & Coast DHB (CCDHB) with an acute exacerbation of COPD, confirmed by lung function tests and clinical history. Data from physiological lung function tests, as a measure of disease severity, will be gathered from clinical records or after discharge from hospital, but will not be possible to routinely gather during the hospital stay as severe episodes of AECOPD limit accurate performance of spirometry.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications for pulmonary rehabilitation such as advanced malignancies, unstable heart conditions, or active psychiatric disorders.

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)
Participants will be randomised to one of the two groups below by third-party methods (central administration of randomisation). The randomisation sequence will be concealed from investigators involved in participant recruitment, baseline and outcome data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence for allocation of participants to groups will be pre-established using block randomisation via www.randomization.com,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Participants will be recruited in hospital before discharge (preferred method), or by phone after discharge.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary analysis will be Poisson regression to estimate the relative rate of moderate or severe AECOPD, with an offset for the time of observation, and with co-variates including the number of COPD-related admissions and ED visits over the 12 months prior to index admission, and the randomised treatment. In a sub-group analysis we will add ethnicity and the interaction between randomised treatment and ethnicity. Continuous variables will be analysed by ANCOVA and categorical variables by logistic regression.

This study is a feasibility study however - to gather data in preparation for a fully powered RCT at a later date. The key element for the full RCT is estimation of rates of AECOPD. This will be estimated by a Poisson regression model with an intercept term only. A sample size of 55 has 80% power to rule out a lower 95% confidence limit for an AECOPD rate of less than 1 (should it in fact be 2). A sample size of 20 has over 80% power to rule out a lower 95% confidence limit of 2 (should it in fact be 3). Sixty participants allow us to randomised 30 into the intervention group to fully test other aspects of our study methods qualitatively. This includes collecting qualitative data on participants and personnel experience of receiving and delivering the intervention, which we will analyse using thematic analysis and constant comparative methods.

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 outside Australia
Country [1] 9010 0
New Zealand
State/province [1] 9010 0
Wellington

Funding & Sponsors
Funding source category [1] 296794 0
Government body
Name [1] 296794 0
Health Research Council of New Zealand
Address [1] 296794 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 296794 0
New Zealand
Primary sponsor type
Individual
Name
A/Prof William Levack
Address
Rehabilitation Teaching & Research Unit, Department of Medicine, University of Otago, Wellington, PO Box 7343, Wellington 6242.
Country
New Zealand
Secondary sponsor category [1] 295788 0
None
Name [1] 295788 0
Address [1] 295788 0
Country [1] 295788 0
Other collaborator category [1] 279610 0
Other
Name [1] 279610 0
Capital & Coast District Health Board
Address [1] 279610 0
c/o Marina Dzhelali, Research Office, Wellington Regional Hospital, Private Bag 7902, Wellington 6242
Country [1] 279610 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298029 0
Health & Disability Ethics Committees of New Zealand
Ethics committee address [1] 298029 0
Ministry of Health, Health and Disability Ethics Committees, PO Box 5013, Wellington 6140
Ethics committee country [1] 298029 0
New Zealand
Date submitted for ethics approval [1] 298029 0
07/07/2017
Approval date [1] 298029 0
Ethics approval number [1] 298029 0

Summary
Brief summary
Every year in NZ there are over 12,000 hospital admissions for acute exacerbation of
chronic obstructive pulmonary disease (AECOPD), costing $60 million annually. Many
of these admissions are due to repeat episodes of AECOPD. We propose to conduct a
clinical trial to test the effectiveness of a behavioural intervention to help people take
charge of their health condition after discharge from hospital for AECOPD and to
facilitate greater uptake of pulmonary rehabilitation – an existing programme of
exercise and education that is known to reduce hospitalisation rates for AECOPD, but
for which there is currently low uptake. Our feasibility study includes evaluation of
current AECOPD rates for the sample size calculation in the full study, plus evaluation
of recruitment and retention rates; the acceptability, cultural appropriateness, and cost
of the behaviour intervention; the suitability of training and support for personnel
delivering the intervention; and a test of intervention fidelity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75746 0
A/Prof William M M Levack
Address 75746 0
Rehabilitation Teaching & Research Unit, Department of Medicine, University of Otago, PO Box 7343, Wellington 6242.
Country 75746 0
New Zealand
Phone 75746 0
+6421918627
Fax 75746 0
Email 75746 0
william.levack@otago.ac.nz
Contact person for public queries
Name 75747 0
A/Prof William Levack
Address 75747 0
Rehabilitation Teaching & Research Unit, Department of Medicine, University of Otago, PO Box 7343, Wellington 6242.
Country 75747 0
New Zealand
Phone 75747 0
+6421918627
Fax 75747 0
Email 75747 0
william.levack@otago.ac.nz
Contact person for scientific queries
Name 75748 0
A/Prof William Levack
Address 75748 0
Rehabilitation Teaching & Research Unit, Department of Medicine, University of Otago, PO Box 7343, Wellington 6242.
Country 75748 0
New Zealand
Phone 75748 0
+6421918627
Fax 75748 0
Email 75748 0
william.levack@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable