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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
Scientific title
Multidisciplinary (TEAM) care of Chronic Obstructive Pulmonary Disease (COPD) for exercise capacity and functional health: TEAMcare for COPD
Secondary ID [1] 286289 0
Nil
Universal Trial Number (UTN)
Trial acronym
TEAMcare for COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 294372 0
Condition category
Condition code
Respiratory 294686 294686 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 291317 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297636 0
1. Walking endurance assessed using with the 6-minute walk test (6MWT)
Timepoint [1] 297636 0
10 weeks post randomisation
Primary outcome [2] 297670 0
2. Health-related quality of life scores assessed using the COPD assessment test (CAT, scores 0 to 40).
Timepoint [2] 297670 0
10 weeks post randomisation
Secondary outcome [1] 321658 0
1. Breathlessness assessed using the Modified British Research Council questionnaire (mMRC, severity, grades 0 to 4).
Timepoint [1] 321658 0
10 weeks post randomisation
Secondary outcome [2] 321659 0
2. Depressive symptoms assessed using the Patient Health Questionnaire 9-item (PHQ-9) scale.
Timepoint [2] 321659 0
10 weeks post randomisation
Secondary outcome [3] 321769 0
3. Anxiety symptoms assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale
Timepoint [3] 321769 0
10 weeks post randomisation
Secondary outcome [4] 321770 0
4. Physical symptoms assessed using the PHQ-15 scale
Timepoint [4] 321770 0
10 weeks post randomisation
Secondary outcome [5] 321771 0
5. Acceptability of TEAMcare to patients, assessed through semi-structured interviews of 30-45 minutes.
Timepoint [5] 321771 0
4 to 6 months post randomisation

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
12/11/2013
Date of last participant enrolment
Anticipated
Actual
27/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5416 0
Campbelltown Hospital - Campbelltown

Funding & Sponsors
Funding source category [1] 293083 0
Self funded/Unfunded
Name [1] 293083 0
Country [1] 293083 0
Primary sponsor type
University
Name
Western Sydney University
Address
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country
Australia
Secondary sponsor category [1] 291868 0
None
Name [1] 291868 0
Address [1] 291868 0
Country [1] 291868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294591 0
Research aEthics Office, South Western Sydney Local Health District (SWSLHD)
Ethics committee address [1] 294591 0
Ethics committee country [1] 294591 0
Australia
Date submitted for ethics approval [1] 294591 0
24/09/2012
Approval date [1] 294591 0
04/02/2013
Ethics approval number [1] 294591 0
HREC/12/LPOOL/349

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

Contacts
Principal investigator
Name 55438 0
Dr Evan Atlantis
Address 55438 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 55438 0
Australia
Phone 55438 0
+61 2 4620 3263
Fax 55438 0
Email 55438 0
E.Atlantis@westernsydney.edu.au
Contact person for public queries
Name 55439 0
Evan Atlantis
Address 55439 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 55439 0
Australia
Phone 55439 0
+61 2 4620 3263
Fax 55439 0
Email 55439 0
E.Atlantis@westernsydney.edu.au
Contact person for scientific queries
Name 55440 0
Evan Atlantis
Address 55440 0
Western Sydney University
Locked Bag 1797 Penrith NSW 2751 Australia
Country 55440 0
Australia
Phone 55440 0
+61 2 4620 3263
Fax 55440 0
Email 55440 0
E.Atlantis@westernsydney.edu.au

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.