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Trial registered on ANZCTR


Registration number
ACTRN12606000082505
Ethics application status
Approved
Date submitted
31/01/2006
Date registered
23/02/2006
Date last updated
23/02/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of a six week Stanford Model chronic disease self management program, a six week pulmonary rehabilitation program with/without weekly maintenance in chronic obstructive pulmonary disease
Scientific title
A randomised controlled trial of the effects of a patient self-management program compared with a pulmonary rehabilitation program on physiological, psychological and economic health outcomes in Chronic Obstructive Pulmonary Disease in north - west Melbourne
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 1046 0
Condition category
Condition code
Respiratory 1124 1124 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 1125 1125 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects are randomised to the six-week self-management program Stanford Model Chronic Disease Self-Management Program (CDSMP).
The CDSMP is a licensed program conducted under licence from Arthritis Victoria by a registered nurse with either a clinician or peer leader, both of whom are accredited with Arthritis Victoria as program facilitators. The six week program comprises a two an a half hour per week group attendance and covers formation of action plans, relaxation therapy, medication usage, effective communication with the health care team, nomination of a power of attorney, end of life decision making, encouragement of candidate to participate in activity (eg walking) and symptom management. The program is facilitated in a manner to foster participant self efficacy with weekly feedback from the program facilitators. For the duration of the intervention each participant wears a pedometer.
Intervention code [1] 876 0
None
Comparator / control treatment
Subjects are randomised to a six week pulmonary rehabilitation program (PRP). Pulmonary rehabilitation subjects are re- randomised at week 7 to weekly maintenance (PRP+m) or, usual care. The six week PRP is a twice weekly 90 minute program conducted by a registered nurse with gymnasium attendance assisted by an allied health clinician (physiotherapist &/or allied health assistant). The program comprises lower limb exercise therapy ( walking, stair climbing, cycling) and limited upper limb exercises (free weights) facilitated in a manner to foster participant self efficacy with weekly feedback from the program facilitators. For the duration of the intervention each participant wears a pedometer. The weekly maintenance (PRP+m) consists of one hour of weekly gymnasium attendance for sixteen weeks. The gym program is identical to the six week program in structure and content.
Control group
Active

Outcomes
Primary outcome [1] 1504 0
Health Related Quality of Life
Timepoint [1] 1504 0
Followed from baseline, week 7,26 and 52 (study completion)
Primary outcome [2] 1505 0
Exercise Tolerance
Timepoint [2] 1505 0
Followed from baseline, week 7,26 and 52 (study completion)
Primary outcome [3] 1506 0
Dyspnea
Timepoint [3] 1506 0
Followed from baseline, week 7,26 and 52 (study completion)
Primary outcome [4] 1507 0
Anxiety
Timepoint [4] 1507 0
Followed from baseline, week 7,26 and 52 (study completion)
Primary outcome [5] 1508 0
Depressions
Timepoint [5] 1508 0
Followed from baseline, week 7,26 and 52 (study completion)
Primary outcome [6] 1509 0
Self-Efficacy
Timepoint [6] 1509 0
Followed from baseline, week 7,26 and 52 (study completion)
Primary outcome [7] 1510 0
Health Care Usage: Hospital admissions & length of stay, emergency department presentations, ambulatory care use, community resource & medication usage
Timepoint [7] 1510 0
Followed from baseline, week 7,26 and 52 (study completion)
Secondary outcome [1] 2704 0
None.
Timepoint [1] 2704 0

Eligibility
Key inclusion criteria
Diagnosis of COPD, Candidates who report activity limited by dyspnea,Clinically stable for a minimum of 4 weeks prior to trial entry, Literate in English,Intact cognitive function.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Completion of a pulmonary rehabilitation in the previous six months,Any medical condition that could place a candidate‘at risk’ during the assessment procedure or, gymnasium program.

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)
subjects consent to partiicpation prior to randomization. Sealed opaque envelopes were used for randomization to an intervention group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each candidate is randomized from a store of three sealed opaque envelopes (1 self management, 2 rehabilitation) which are replenished after each candidate is randomised. The candidate selects one envelope in the presence of the researcher and the candidate's family/significant others. The contents of the other two envelopes are then displayed. Group allocation occurs in much the same way as a roll of a dice.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

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

Funding & Sponsors
Funding source category [1] 1228 0
Government body
Name [1] 1228 0
The Northern Hospital's Hospital At Risk Program (HARP) funding, Department of Human Services, Victoria
Address [1] 1228 0
Country [1] 1228 0
Australia
Primary sponsor type
Hospital
Name
The Northern Hospital, ACU National
Address
Country
New Zealand
Secondary sponsor category [1] 1085 0
None
Name [1] 1085 0
Not Applicable
Address [1] 1085 0
Country [1] 1085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2557 0
ACU National
Ethics committee address [1] 2557 0
Ethics committee country [1] 2557 0
Australia
Date submitted for ethics approval [1] 2557 0
Approval date [1] 2557 0
Ethics approval number [1] 2557 0
Ethics committee name [2] 2558 0
The Northern Hospital
Ethics committee address [2] 2558 0
Ethics committee country [2] 2558 0
Australia
Date submitted for ethics approval [2] 2558 0
Approval date [2] 2558 0
Ethics approval number [2] 2558 0

Summary
Brief summary
The project aims to investigate in a sample of people with chronic obstructive pulmonary disease the effects of a psychological intervention as compared to a pulmonary rehabilitation program and then; compare six weeks of rehabilitation with and without weekly maintenance and construct a model to identify candidates who benefit most from maintenance. The incremental cost effectiveness of the three interventions will then be evaluated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36142 0
Address 36142 0
Country 36142 0
Phone 36142 0
Fax 36142 0
Email 36142 0
Contact person for public queries
Name 10065 0
Maria Murphy
Address 10065 0
C/- School of Nursing
Australian Catholic University (ACU) National
St Patricks Campus
115 Victoria Parade
Fitzroy Melbourne VIC 3065
Country 10065 0
Australia
Phone 10065 0
+61 3 94965677
Fax 10065 0
Email 10065 0
maria.murphy@ austin.org.au
Contact person for scientific queries
Name 993 0
Dr Michelle Campbell
Address 993 0
Head
School of Nursing
Australian Catholic University (ACU) National
St Patricks Campus
115 Victoria Parade
Fitzroy Melbourne VIC 3065
Country 993 0
Australia
Phone 993 0
+61 3 99533184
Fax 993 0
+61 3 99533385
Email 993 0
Michelle.Campbell @ acu.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary