Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000299505
Ethics application status
Approved
Date submitted
10/07/2006
Date registered
12/07/2006
Date last updated
28/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The Southern Adelaide COPD study
Scientific title
Predictors of hospital admission in patients with COPD and cost-effectiveness of the Southern Adelaide Chronic Disease Community Program
Secondary ID [1] 251896 0
Flinders Clinical Research Ethics Committee, Research Application 52/056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 1274 0
Condition category
Condition code
Respiratory 1361 1361 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective randomised controlled trial of the costs and benefits of the Chronic Disease Community Program compared to usual care, in patients with COPD.

Study Intervention
The Chronic Disease Community Program (CDCP) is a health systems intervention. CDCP aims to:
1. Improve information flow between hospitals, GPs and community-based health providers
2. Facilitate case conferences and care planning where appropriate
3. Increase access to Chronic Disease Self Management (CDSM) Programs and telephone coaching, home medicines review, allied health assessments and interventions and oral health care.
4. Plan and coordinate services to meet individual patient needs
Individual programs are usually completed within 6 months, depending on access and scheduling of program components.
Intervention code [1] 1196 0
Treatment: Other
Comparator / control treatment
Control intervention
The control group will receive usual care from their general practitioner and other community health providers for 6 months following discharge from hospital. After 6 months, these participants can elect to participate in the CDCP.
Control group
Active

Outcomes
Primary outcome [1] 1854 0
Rate of COPD-related hospital readmission.
Timepoint [1] 1854 0
At 6 months
Secondary outcome [1] 3265 0
Health resource utilisation and costs
Timepoint [1] 3265 0
Self-report at baseline and 6 months
Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Schedule (PBS) data at 6 months
Direct cost of CDCP interventions
Inpatient costs associated with COPD-related readmission
Secondary outcome [2] 3266 0
Assessment of Quality of Life (AQoL)
Timepoint [2] 3266 0
Baseline and 6 months

Eligibility
Key inclusion criteria
Patients admitted to Flinders Medical Centre with a primary diagnosis of COPD from mid-July 2006 to Dec 31st 2007 and who consent to participate in the CDCP intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are admitted to hospital from, or returning to, a residential aged care facility.

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)
Sealed opaque envelopes. Clinical trials staff within the Pharmacy Department at FMC will hold the envelopes. Allocation will involve contacting Pharmacy staff to open the sealed envelope and reveal the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, block sizes are variable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
17/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1493 0
University
Name [1] 1493 0
Flinders University
Country [1] 1493 0
Australia
Funding source category [2] 1494 0
Other
Name [2] 1494 0
Southern Adelaide Health Service
Country [2] 1494 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100, Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 1313 0
None
Name [1] 1313 0
Nil
Address [1] 1313 0
Country [1] 1313 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2915 0
Flinders Medical Centre
Ethics committee address [1] 2915 0
Ethics committee country [1] 2915 0
Australia
Date submitted for ethics approval [1] 2915 0
Approval date [1] 2915 0
26/06/2006
Ethics approval number [1] 2915 0
52/056

Summary
Brief summary
Chronic Obstructive Pulmonary Disease (COPD) is often associated with high health care costs and a reduced quality of life for sufferers. Many different approaches have been used to assist patients to manage their condition at home and to improve communication between hospitals and GPs. Some approaches have been very successful, others less so. Some programs are expensive and some patients derive greater benefit than others.

This study examines the costs and benefits of a program run by the Southern Adelaide Health Service (SAHS) for people with chronic lung disease, diabetes and heart failure. The study examines what impact the program is having on the rate of readmission to hospital, GP visits and other health costs, including use of medicines, for people with COPD. We will compare the Southern Adelaide program with usual care when a patient has had a recent hospital admission.
Measuring lung function when a person with chronic obstructive pulmonary disease (COPD) is well, provides a good indication of disease progression. There may be other simpler indicators however, that help predict when, and how often, a person with chronic lung disease is likely to need hospital care. This is the second question that the study has been designed to answer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35845 0
Address 35845 0
Country 35845 0
Phone 35845 0
Fax 35845 0
Email 35845 0
Contact person for public queries
Name 10385 0
Professor Peter Frith
Address 10385 0
Southern Respiratory Services Repatriation General Hospital Daw Park SA 5043
Country 10385 0
Australia
Phone 10385 0
+61 8 82751671
Fax 10385 0
+61 8 82751195
Email 10385 0
peter.frith@flinders.edu.au
Contact person for scientific queries
Name 1313 0
Professor Peter Frith
Address 1313 0
Southern Respiratory Services
Repatriation General Hospital
Daw Park SA 5043
Country 1313 0
Australia
Phone 1313 0
+61 8 82751671
Fax 1313 0
+61 8 82751195
Email 1313 0
peter.frith@flinders.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.