Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000006640
Ethics application status
Approved
Date submitted
7/07/2005
Date registered
13/07/2005
Date last updated
15/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Pathways Home: Chronic Disease Management Partnerships
Scientific title
The effect of a self-management programme supported by computerised symptom feedback on quality of life in community dwelling people with Chronic Obstructive Pulmonary Disease
Secondary ID [1] 280680 0
Pathways Home 1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 68 0
Condition category
Condition code
Respiratory 80 80 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be recruited at the Royal Hobart Hospital with an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Following discharge, active participants will be provided with a Community Health Nurse mentor who will act to facilitate their self-efficacy over the 1-year duration of the study. Information Technology systems will be developed to enable participants to closely monitor their disease using their newly developed skills of self-efficacy to respond appropriately.
Intervention code [1] 2 0
None
Comparator / control treatment
The comparison group will receive usual treatment for COPD, including follow-up by GP or respiratory specialist.
Control group
Active

Outcomes
Primary outcome [1] 112 0
Health Related Quality of Life
Timepoint [1] 112 0
Baseline, 3, 6, 9 & 12 months
Secondary outcome [1] 250 0
Self-efficacy
Timepoint [1] 250 0
Baseline, 3, 6, 9 & 12 months
Secondary outcome [2] 251 0
Daily physical activity
Timepoint [2] 251 0
Baseline, 3, 6, 9 & 12 months
Secondary outcome [3] 252 0
Symptom scores
Timepoint [3] 252 0
Baseline, 3, 6, 9 & 12 months
Secondary outcome [4] 253 0
Healthcare resource utilisation
Timepoint [4] 253 0
12 months

Eligibility
Key inclusion criteria
Lives in catchment area;Formal diagnosis of COPD following the COPDX guidelines, including spirometry;Has had one exacerbation of COPD in the last 12 months, including current if applicable;Passes a cognitive assessment, has ability to fill in questionnaires and understand IT. Mini Mental score >21 for client and for those carers responsible for IT;Able to provide informed consent; Home environment has the capacity to cope with IT;Has telephone.
Minimum age
45 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of other active lung disease; Undergoing palliative care.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment
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
Parallel
Other design features
By domicile
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 116 0
Government body
Name [1] 116 0
Commonwealth Department of Health and Ageing
Country [1] 116 0
Australia
Primary sponsor type
Government body
Name
Tasmanian Department of Health and Human Services
Address
34 Murray Street, Hobart, 7000
Country
Australia
Secondary sponsor category [1] 85 0
University
Name [1] 85 0
School of Medicine, School of Nursing, School of Information Systems (University of Tasmania)
Address [1] 85 0
Private Bag, Hobart, 7001
Country [1] 85 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287454 0
Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 287454 0
Ethics committee country [1] 287454 0
Australia
Date submitted for ethics approval [1] 287454 0
Approval date [1] 287454 0
Ethics approval number [1] 287454 0
H8370

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

Contacts
Principal investigator
Name 35893 0
Address 35893 0
Country 35893 0
Phone 35893 0
Fax 35893 0
Email 35893 0
Contact person for public queries
Name 9191 0
Richard Wood-Baker
Address 9191 0
Discipline of Medicine University of Tasmania Private Bag 34 Hobart TAS 7001
Country 9191 0
Australia
Phone 9191 0
+61 3 6222 7353
Fax 9191 0
+61 3 6222 7579
Email 9191 0
[email protected]
Contact person for scientific queries
Name 119 0
Dr Richard Wood-Baker
Address 119 0
Discipline of Medicine
University of Tasmania
Private Bag 34
Hobart TAS 7001
Country 119 0
Australia
Phone 119 0
+61 3 6222 7353
Fax 119 0
+61 3 6222 7579
Email 119 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
Dimensions AIClinical diaries in COPD: compliance and utility in predicting acute exacerbations2012https://doi.org/10.2147/copd.s32222
N.B. These documents automatically identified may not have been verified by the study sponsor.