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
Research Services, University of Tasmania, Private Bag 1, Hobart, Tasmania, 7001
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
We investigated the effect of a programme to increase self-management behaviours delivered by community health nurses, compared to usual care, on health-related quality of life and healthcare utilisation in people with COPD following hospitalisation.

Participants were recruited during an admission to hospital and allocated according to domicile. The mentor role was to collaboratively develop self-management strategies over the 12-month study duration. Outcomes included quality of life and healthcare utilisation.

Linear mixed models analyses found a significant benefit in the Physical Functioning and General Health components of the SF-36 questionnaire for the mentored arm, the average difference between interventions being 5.60 and 4.14 respectively over 12 months. Survival analysis using a combined end-point of time to next acute exacerbation requiring rehospitalisation or death found a significant benefit favouring the mentored group (p = 0.037).
Trial website
Trial related presentations / publications
E Cummings, A Robinson, H Courtney-Pratt, H Cameron-Tucker, R Wood-Baker, E Walters, P Turner
Pathways Home: Comparing Voluntary IT and Non-IT Users Participating in a Mentored Self-Management Project
Stud Health Technol Inform. 2010;160:23-7

K Willis, A Robinson, R Wood-Baker, E Walters, P Turner
Participating in Research: Exploring Participation and Engagement in a Study of Self-Management for People With Chronic Obstructive Pulmonary Disease
Qualitative Health Research 2011; 21(9): 1283-1294
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.