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Trial registered on ANZCTR
Registration number
ACTRN12616000342415
Ethics application status
Approved
Date submitted
10/03/2016
Date registered
16/03/2016
Date last updated
16/03/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Multidisciplinary (TEAM) care of Chronic Obstructive Pulmonary Disease (COPD) for exercise capacity and functional health: TEAMcare for COPD
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Scientific title
Multidisciplinary (TEAM) care of Chronic Obstructive Pulmonary Disease (COPD) for exercise capacity and functional health: TEAMcare for COPD
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Secondary ID [1]
286289
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Nil
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Universal Trial Number (UTN)
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Trial acronym
TEAMcare for COPD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Collaborative, multidisciplinary care.
Subjects attended for follow up visits at five and ten months to ascertain clinical status, algorithm compliance and to review and revise management recommendations. The intervention was conducted using existing resources, involving collaboration with general practice and the publicly-funded local chronic disease management programme. Stakeholders provided qualitative feedback about the intervention in terms of feasibility, acceptability and barriers via structured and semi-structured interviews.
All participants received the TEAMcare intervention, which will entail pulmonary rehabilitation (regarded as standard care for COPD management) integrated within individualised structured management plans prescribed by the Chief Investigator (Dr Belinda Cochrane, Staff Specialist Respiratory and Sleep Physician) following a comprehensive baseline (pre-test) assessment of COPD and prognostic factors (biological, psychological, and behavioural), exercise capacity (cardiorespiratory fitness and muscle strength) and functional health (health-related quality of life/disability). Pulmonary rehabilitation will be a modified version of the national Healthy Eating Activity and Lifestyle (HEAL 'Trademark') program currently being delivered by South Western Sydney Medicare Local Ltd. HEAL 'Trademark', which consists of eight weekly group education (1 hour weekly) and group exercise sessions (1 hour weekly, aerobic and resistance exercise instruction for the home by accredited exercise physiologists and dietitians) as well as individual assessments before and after the program, and at five and 12 months follow-up. Each week participants undertook one hour of supervised group-based low to moderate intensity physical activity followed by a one hour group-based healthy lifestyle and disease education class, including recommendations for achieving sustainable ideal changes in body weight for patients with COPD. The HEAL staff recorded participant attendance. A nurse case officer was assigned to work with the patient to co-ordinate the pulmonary rehabilitation and any individualised health services according to their management plan (e.g. access to mental health or other medical specialists; disease and end of life education; smoking cessation program). After an initial face-to-face contact session of 30-40 minutes, subsequent contacts were by weekly telephone sessions of 15-20 minutes each over the 10 week period. The nurse case officer would monitor symptoms monthly (breathlessness, depression and anxiety), and reinforce information provided by Chief Investigator about their individualised management plan, and address any difficulties with its implementation, taking into account patients’ needs and preferences and keep a TEAMcare log for adherence.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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1. Walking endurance assessed using with the 6-minute walk test (6MWT)
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Assessment method [1]
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Timepoint [1]
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10 weeks post randomisation
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Primary outcome [2]
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2. Health-related quality of life scores assessed using the COPD assessment test (CAT, scores 0 to 40).
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Assessment method [2]
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Timepoint [2]
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10 weeks post randomisation
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Secondary outcome [1]
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1. Breathlessness assessed using the Modified British Research Council questionnaire (mMRC, severity, grades 0 to 4).
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Assessment method [1]
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Timepoint [1]
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10 weeks post randomisation
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Secondary outcome [2]
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2. Depressive symptoms assessed using the Patient Health Questionnaire 9-item (PHQ-9) scale.
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Assessment method [2]
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Timepoint [2]
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10 weeks post randomisation
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Secondary outcome [3]
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3. Anxiety symptoms assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale
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Assessment method [3]
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Timepoint [3]
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10 weeks post randomisation
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Secondary outcome [4]
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4. Physical symptoms assessed using the PHQ-15 scale
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Assessment method [4]
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Timepoint [4]
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10 weeks post randomisation
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Secondary outcome [5]
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5. Acceptability of TEAMcare to patients, assessed through semi-structured interviews of 30-45 minutes.
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Assessment method [5]
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Timepoint [5]
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4 to 6 months post randomisation
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Eligibility
Key inclusion criteria
Male or female patients aged 40 years or older with symptoms and spirometry consistent with moderate to severe COPD diagnosis, as defined by the GOLD criteria, who have given freely written informed consent will be eligible to participate, unless exclusion criteria are present
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with symptoms of unstable angina, or heart attack within the previous 8 weeks at the time of screening, who have previously participated in a pulmonary rehabilitation program, unable to walk, and not proficient in English will be excluded
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
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Actual
12/11/2013
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Date of last participant enrolment
Anticipated
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Actual
27/05/2014
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
University
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Name
Western Sydney University
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Address
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Research aEthics Office, South Western Sydney Local Health District (SWSLHD)
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Ethics committee address [1]
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Research and Ethics office
Locked Bag 7103, LIVERPOOL BC, NSW, 1871
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/09/2012
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Approval date [1]
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04/02/2013
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Ethics approval number [1]
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HREC/12/LPOOL/349
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Summary
Brief summary
Chronic obstructive pulmonary disease (COPD) is now considered a multisystem disease, in which comorbidities feature prominently. COPD guidelines recommend holistic assessment and management of relevant comorbid diseases but there is limited information as to how this is best achieved. This pilot study aimed to explore the views of stakeholders, including patients and the healthcare team, on the feasibility, acceptability and barriers to a collaborative, multidisciplinary team-based care intervention (TEAMcare) to improve health outcomes in COPD patients, within the context of a local hospital outpatient clinic.
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Trial website
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Trial related presentations / publications
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Public notes
The study was terminated prematurely due to poor recruitment and clear lack of feasibility.
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Contacts
Principal investigator
Name
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Dr Evan Atlantis
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Address
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Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
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Country
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Australia
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Phone
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+61 2 4620 3263
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Evan Atlantis
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Address
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Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
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Country
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Australia
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Phone
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+61 2 4620 3263
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Evan Atlantis
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Address
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Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
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Country
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Australia
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Phone
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+61 2 4620 3263
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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