Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000112369
Ethics application status
Approved
Date submitted
26/02/2008
Date registered
28/02/2008
Date last updated
5/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Pathways to Lung Health:a comprehensive
Self-Management Programme for Chronic
Obstructive Pulmonary Disease in the community
Scientific title
The effect of telphone delivered health-mentoring by community and practice nurses on quality of life in Chronic Obstructive Pulmonary Disease compared to usual care in the community.
Secondary ID [1] 259652 0
not required
Secondary ID [2] 259653 0
not required
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 2869 0
Condition category
Condition code
Respiratory 3005 3005 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient participants recruited in practices in the active arm will have an individual management plan developed by the research team in consultation with their general practitioner. Community and practice nurses, trained in a model of behaviour change based on motivational interviewing to improve self-efficacy, will work in partnership with participants to achieve behavioural change through a cycle of goal setting and action planning during regular telephone contacts over 12 months. Goals will focus on health behaviours identified in the management plan to support patients to develop capacity to self-manage their chronic illness.
Intervention code [1] 2599 0
Behaviour
Intervention code [2] 2600 0
Treatment: Other
Intervention code [3] 2601 0
Lifestyle
Comparator / control treatment
Patient participants recruited in practices in the the usual care arm will have an individual management plan developed by the research team in consultation with their general practitioner.
Control group
Active

Outcomes
Primary outcome [1] 3887 0
Medical Outcomes Study SF-36 v2 quality of life (generic health related)
Timepoint [1] 3887 0
Baseline, 6 months and 12 months after intervention commencement, at 6 months and 12 months following intervention cessation
Primary outcome [2] 290170 0
St George's Respiratory Questionnaire quality of life (respiratory related)
Timepoint [2] 290170 0
Baseline, 6 months and 12 months after intervention commencement.
6 months and 12 months following intervention cessation.
Secondary outcome [1] 6530 0
Center for Epidemiologic Studies Depression Scale
Timepoint [1] 6530 0
Baseline, 6 months and 12 months after intervention commencement, at 6 months and 12 months following intervention cessation
Secondary outcome [2] 6531 0
PTSD Checklist-Civilian Version (PCL-C) anxiety measure
Timepoint [2] 6531 0
Baseline, 6 months and 12 months after intervention commencement, at 6 months and 12 months following intervention cessation
Secondary outcome [3] 6532 0
Hospital Anxiety and Depression scale
Timepoint [3] 6532 0
Baseline, 6 months and 12 months after intervention commencement, at 6 months and 12 months following intervention cessation.
Secondary outcome [4] 6533 0
Satisfaction With Life Survey
Timepoint [4] 6533 0
Baseline, 6 months and 12 months after intervention commencement, at 6 months and 12 months following intervention cessation
Secondary outcome [5] 6534 0
Client Satisfaction Questionnaire (mentoring process)
Timepoint [5] 6534 0
Baseline and 6 months after intervention commencement
Secondary outcome [6] 6535 0
Lung function measured by spirometry (FEV1, FVC, FEF 25-75%)
Timepoint [6] 6535 0
Baseline, 6 months and 12 months after intervention commencement, at 6 months and 12 months following intervention cessation
Secondary outcome [7] 6536 0
Health care utilization measured by general practitioner routine and urgent attendances, public hospital admissions and emergency visits for Chronic Obstructive Pulmonary Disease
Timepoint [7] 6536 0
12 months prior to intervention commencement , during 12 months intervention, 12 months post intervention completion
Secondary outcome [8] 6537 0
Prescriptions for oral steroids and antibiotics for exacerbations of Chronic Obstructive Pulmonary Disease recorded in general practitioner records
Timepoint [8] 6537 0
12 months prior to intervention commencement , during 12 months intervention, 12 months post intervention completion
Secondary outcome [9] 6556 0
Physical activity (steps/day) measured with accelerometer
Timepoint [9] 6556 0
7day periods at baseline, 6 months and 12 months after intervention commencement, at 6 months and 12 months following intervention cessation
Secondary outcome [10] 273274 0
Fidelity of delivery of intervention assessed from sample of recorded mentoring phone calls
Timepoint [10] 273274 0
At completion of mentoring and control phone calls
Secondary outcome [11] 273279 0
Qualitative assessment of health-mentoring using semi-structured interviews with representative sample of 35-45 participants in intervention arm
Timepoint [11] 273279 0
Completion of/ or withdrawal from intervention
Secondary outcome [12] 304043 0
Partners in Health Scale
Timepoint [12] 304043 0
Baseline, 6 months, 12 months
Secondary outcome [13] 304044 0
Self-efficacy for managing chronic disease (SE MCD) 6-item questionnaire
Timepoint [13] 304044 0
Baseline, 6 months, 12 months

Eligibility
Key inclusion criteria
1. Chronic obstructive pulmonary disease FEV1/FVC < 0.7 post-bronchodilator
2. Severity FEV1 30-80% predicted
3. > 10 pack year smoking history
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No expectation of terminal lung disease or another terminal disease within 2 years

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)
Patients will be allocated to intervention or control arms according to their practice randomisation. The study design is cluster randomised by general practice, with 10 patients with Chronic Obstructive Pulmonary Disease recruited per practice and outcome data analysed at individual patient level using mixed models to compare mean change in the outcome factors between each arm of the study, with the practice declared a random factor to account for clustering of patients within practices.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomisation is the general practice to avoid contamination between groups. They will be randomised to active or control intervention using computer generated random numbers with stratification for rurality and socio-economic demographics from the Australian Bureau of Statistics.
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
The study was powered on a sample size of 200 participants to detect differences in mean QOL scores in SF36 in COPD for physical functioning (PF) of 8.1 and for general health (GH) of 6.3, with 80% power at level of significance alpha 0.05, assuming an intra class correlation coefficient of 0.05 and cluster size of 10.
Proportion participants with hospital admission analysed by chi-square tests.
Effects of the intervention on outcome measures over 12-months were estimated using multilevel mixed-effects linear models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/03/2008
Actual
14/05/2008
Date of last participant enrolment
Anticipated
Actual
3/08/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 3122 0
Government body
Name [1] 3122 0
National Health and Medical Research Council (NHMRC)
Country [1] 3122 0
Australia
Funding source category [2] 3123 0
University
Name [2] 3123 0
University of Tasmania
Country [2] 3123 0
Australia
Primary sponsor type
University
Name
Menzies Research Institute Tasmania
Address
MS1 17 Liverpool Street,
PB23
Hobart 7001
Tasmania
Country
Australia
Secondary sponsor category [1] 2810 0
Government body
Name [1] 2810 0
Department 0f Health & Human Services, Tasmania
Address [1] 2810 0
34 Davey Street, Hobart TAS 7000
Postal
GPO Box 125, Hobart TAS 7001
Country [1] 2810 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5099 0
Tasmanian Human Research Ethics Committee (HREC) Tasmania
Ethics committee address [1] 5099 0
Ethics committee country [1] 5099 0
Australia
Date submitted for ethics approval [1] 5099 0
Approval date [1] 5099 0
29/11/2007
Ethics approval number [1] 5099 0
H0009777

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

Contacts
Principal investigator
Name 28401 0
A/Prof R. Wood-Baker
Address 28401 0
MS1 UTAS
PB 34
University of Tasmania
Hobart
TAS 7001
Country 28401 0
Australia
Phone 28401 0
+61 3 6226 4798
Fax 28401 0
Email 28401 0
[email protected]
Contact person for public queries
Name 11558 0
Dr Julia Walters
Address 11558 0
MS1 UTAS
PB 34
University of Tasmania
Hobart
TAS 7001
Country 11558 0
Australia
Phone 11558 0
03 6226 4798
Fax 11558 0
03 6226 7704
Email 11558 0
[email protected]
Contact person for scientific queries
Name 2486 0
A/Prof Richard Wood-Baker
Address 2486 0
MS1 UTAS
PB 34
University of Tasmania
Hobart
TAS 7001
Country 2486 0
Australia
Phone 2486 0
03-6222-7353
Fax 2486 0
Email 2486 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbasePatient Anxiety and Depression Moderate the Effects of Increased Self-management Knowledge on Physical Activity: A Secondary Analysis of a Randomised Controlled Trial on Health-Mentoring in COPD.2015https://dx.doi.org/10.3109/15412555.2014.995289
N.B. These documents automatically identified may not have been verified by the study sponsor.