Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000167460
Ethics application status
Approved
Date submitted
22/02/2007
Date registered
13/03/2007
Date last updated
25/03/2019
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Community-based health organisations and chronic illness care
Scientific title
Evaluation of the provision of mailed print-based information to increase access to community-based health organisations among general practice patients with chronic disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Access to community-based health organisations amongst patients with chronic illness 1674 0
Arthritis 1675 0
Osteoporosis 1676 0
Ankylosing spondylitis 1677 0
Asthma 1678 0
Diabetes 1679 0
Hepatitis C 1680 0
Haemochromatosis 1681 0
Kidney disease 1682 0
Condition category
Condition code
Public Health 1777 1777 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General practice patients with chronic disease will be assigned randomly to receive routine care plus mailed letter containing general information plus printed information package providing information about community based health organisations relevant to the patient's chronic condition (Intervention group). At recruitment to the study, all patients will be advised (via a participant information sheet) that they will be mailed one of two information packages, both of which will contain useful information but differing in the amount of information provided: one will contain more detailed information than the other. Patients are advised they will have an equal chance of receiving either of the packages and that the one sent will be decided at random. The patients will retain and have access to the intervention package for the duration of the 12-month study and beyond.
Intervention code [1] 1620 0
Other interventions
Comparator / control treatment
General practice patients with chronic disease will be assigned randomly to receive routine care plus mailed letter containing general information (Control group). At recruitment to the study, all patients will be advised (via a participant information sheet) that they will be mailed one of two information packages, both of which will contain useful information but differing in the amount of information provided: one will contain more detailed information than the other. Patients are advised they will have an equal chance of receiving either of the packages and that the one sent will be decided at random. The patients will retain and have access to the intervention package for the duration of the 12-month study and beyond.
Control group
Active

Outcomes
Primary outcome [1] 2484 0
Access to community based health organisations will be assessed by self-report using questions asking whether the patient has contacted/participated in an organisation and, if so, the frequency and nature of their contact/participation.
Timepoint [1] 2484 0
Collected by telephone interview at baseline and 3- and 10-12 months post-intervention.
Secondary outcome [1] 4276 0
Secondary outcomes are self-management and subjective health.
Self-management will be assessed using the 13-item version of the Patient Activation Measure (Hibbard, 2003) and a series of questions about health actions taken, including service use, adapted from the National Health Survey (2005). Subjective health will be assessed using the SF-12, version 2.
Timepoint [1] 4276 0
All data will be self-report by telephone interview at baseline, 3- and 10-12 months.

Eligibility
Key inclusion criteria
Confirmed (by general practitioner) diagnosis of arthritis, osteoporosis, ankylosing spondylitis, asthma, diabetes, hepatitis C, haemochromatosis, or kidney disease.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment that precludes provision of informed consent; Non-English speaking or otherwise unable to complete a telephone interview.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited at general practice consultation, enrolment follows completion of telephone survey. Allocation to intervention/control group carried out by project officer using computer-generated random numbers. A treatment allocation envelope corresponding to each randomly determined number will be drawn for each patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/03/2007
Actual
19/03/2007
Date of last participant enrolment
Anticipated
Actual
31/07/2007
Date of last data collection
Anticipated
Actual
25/07/2008
Sample size
Target
650
Accrual to date
Final
276
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 1927 0
Government body
Name [1] 1927 0
Australian Primary Health Care Research Institute
Country [1] 1927 0
Australia
Primary sponsor type
Individual
Name
Dr Fran Boyle, The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 1739 0
Individual
Name [1] 1739 0
Dr Marie-Louise Dick, The University of Queensland
Address [1] 1739 0
Country [1] 1739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3589 0
School of Population Health, The University of Queensland
Ethics committee address [1] 3589 0
Ethics committee country [1] 3589 0
Australia
Date submitted for ethics approval [1] 3589 0
Approval date [1] 3589 0
06/11/2006
Ethics approval number [1] 3589 0
2005000733

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

Contacts
Principal investigator
Name 27554 0
A/Prof Fran Boyle
Address 27554 0
University of Queensland
Country 27554 0
Australia
Phone 27554 0
0402099556
Fax 27554 0
Email 27554 0
[email protected]
Contact person for public queries
Name 10809 0
Dr Fran Boyle
Address 10809 0
School of Population Health
The University of Queensland
Herston Road, Herston QLD 4029
Country 10809 0
Australia
Phone 10809 0
+61 7 33464681
Fax 10809 0
+61 7 33464717
Email 10809 0
[email protected]
Contact person for scientific queries
Name 1737 0
Dr Fran Boyle
Address 1737 0
School of Population Health
The University of Queensland
Herston Road
Herston QLD 4029
Country 1737 0
Australia
Phone 1737 0
+61 7 33464681
Fax 1737 0
+61 7 33464717
Email 1737 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.