Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612001056886
Ethics application status
Approved
Date submitted
2/10/2012
Date registered
4/10/2012
Date last updated
4/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Nurse-led chronic disease care in Wheatbelt, Western Australia
Scientific title
To investigate whether an intensive practice nurse led chronic heart and lung disease primary care in Wheatbelt general practices will reduce avoidable hospitalisations as compared to routine general practice care.
Secondary ID [1] 281333 0
Nil
Universal Trial Number (UTN)
U1111-1135-3640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 287554 0
COPD 287555 0
hypertension 287556 0
heart disease 287564 0
Condition category
Condition code
Public Health 287880 287880 0 0
Health service research
Cardiovascular 287881 287881 0 0
Hypertension
Respiratory 287890 287890 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be followed up three-monthly over a year. An individualised care plan will be formulated by the practice nurse with the participant in the initial consult (1 hour). This care plan will be reviewed every 3 months (0.5 hour each time). The care plan includes list of medication/s, list of medical condition/ medical history, dietary and lifestyle advice, what to do in medical emergency e.g. acute asthma attack.
Intervention code [1] 285796 0
Lifestyle
Intervention code [2] 285803 0
Treatment: Other
Intervention code [3] 285804 0
Prevention
Comparator / control treatment
Routine practice: ad hoc care
Control group
Active

Outcomes
Primary outcome [1] 288098 0
Number of avoidable hospitalisation for asthma, COPD and hypertension in test and control sites during the intervention period using regional hospital morbidity and mortality dataset
Timepoint [1] 288098 0
3 monthly over a year
Secondary outcome [1] 299426 0
Quality of Life as assessed by the SF-12 questionnaire
Timepoint [1] 299426 0
3 monthly over a year
Secondary outcome [2] 299427 0
Chronic Respiratory Questionnaire
Timepoint [2] 299427 0
3 monthly over a year

Eligibility
Key inclusion criteria
able to give informed consent; have a heart and/or lung chronic disease currently managed in primary care
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent; chronic condition not well controlled or need intensive treatment; deemed not suitable for participation by treating clinicians; participants want to withdraw from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Information sheets for the study are made available at the reception area of each participating general practice. Willing participants send signed consent form to researchers. Participants are screened by nurse whether they fully understand the purpose and scope of the intervention. An individualised care plan is formulated with the respective participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randmised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Mixed methods: embedded QUAN(qual) with focus group conducted with willing informants (not necessarily participants of the study)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286100 0
Government body
Name [1] 286100 0
State Health Research Advisory Council (SHRAC) Translational Research
Country [1] 286100 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Wheatbelt GP Network
Address
PO Box 781 (15 Elizabeth Place)
Northam WA 6401
Country
Australia
Secondary sponsor category [1] 284912 0
Government body
Name [1] 284912 0
WA Country Health Services
Address [1] 284912 0
PO Box 5147 (125 Grey Street West)
Albany WA 6330
Country [1] 284912 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288147 0
Royal Australian College of General Practitioners
Ethics committee address [1] 288147 0
1 Palmerston Crescent,
South Melbourne, VIC 3205
Ethics committee country [1] 288147 0
Australia
Date submitted for ethics approval [1] 288147 0
Approval date [1] 288147 0
24/02/2012
Ethics approval number [1] 288147 0
NREEC11
Ethics committee name [2] 288151 0
WA Country Health Service
Ethics committee address [2] 288151 0
61 Victoria Street,
Bunbury, WA 6230
Ethics committee country [2] 288151 0
Australia
Date submitted for ethics approval [2] 288151 0
Approval date [2] 288151 0
23/03/2012
Ethics approval number [2] 288151 0
2012:03

Summary
Brief summary
To compare whether a nurse-led model of chronic disease care in rural general practice will reduce unwanted hospitalisation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34785 0
Address 34785 0
Country 34785 0
Phone 34785 0
Fax 34785 0
Email 34785 0
Contact person for public queries
Name 18032 0
David Lim
Address 18032 0
PO Box 781 (15 Elizabeth Place)
Northam, WA 6401
Country 18032 0
Australia
Phone 18032 0
+61,8,96211530
Fax 18032 0
+61,8,96211532
Email 18032 0
[email protected]
Contact person for scientific queries
Name 8960 0
David Lim
Address 8960 0
PO Box 781 (15 Elizabeth Place)
Northam, WA 6401
Country 8960 0
Australia
Phone 8960 0
+61,8,96211530
Fax 8960 0
+61,8,96211532
Email 8960 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
No additional documents have been identified.