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Trial registered on ANZCTR


Registration number
ACTRN12613000258752
Ethics application status
Approved
Date submitted
4/03/2013
Date registered
5/03/2013
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Rural patients with Inflammatory Bowel Disease (IBD) – burden of disease and perceived barriers to treatment.
Scientific title
In rural patients with Inflammatory Bowel Disease (IBD) what is the burden of disease and how does this compare with their urban counterparts.
Secondary ID [1] 282051 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Bowel Disease 288525 0
Condition category
Condition code
Oral and Gastrointestinal 288856 288856 0 0
Inflammatory bowel disease
Public Health 288887 288887 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study will look at the burden of disease/health outcomes of rural patients with IBD and be compared with metropolitan patients with IBD. The health outcomes will be gathered through a once off questionnaire.

Rural care providers will be surveyed with a separate questionnaire (once off) to obtain information regarding their IBD practice, IBD knowledge and perceived barriers to care of their IBD patients.

Once both groups have been surveyed (after enrollment in study) they will not be contacted again.
Intervention code [1] 286643 0
Not applicable
Comparator / control treatment
Control group - metropolitan patients with IBD. This cohort will not be contacted as information regarding their health outcomes has previously been collected

Medical Records data for suitable patients from 2002-2012
Control group
Historical

Outcomes
Primary outcome [1] 288984 0
Disease burden/IBD health outcomes of rural IBD patients will be assessed through a once off questionnaire.
Timepoint [1] 288984 0
1 questionnaire at the beginning of the study period. (ie as soon as the participant has consented to the study).
Secondary outcome [1] 301500 0
Data relating to rural doctor's (GP/Surgeon/physician) IBD practice, IBD knowledge and perceived barriers to the care of their IBD patients through a once off questionnaire.
Timepoint [1] 301500 0
1 questionnaire at the beginning of the study period. (ie as soon as the participant has consented to the study).

Eligibility
Key inclusion criteria
1. Patients
- Residing in rural location
- diagnosis of IBD

2. Doctors
- practicing in rural location
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
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)
SA
Recruitment postcode(s) [1] 6448 0
5290 - Mount Gambier

Funding & Sponsors
Funding source category [1] 286824 0
Commercial sector/Industry
Name [1] 286824 0
Janssen
Address [1] 286824 0
Address:
1-5 Khartoum Rd, North Ryde NSW 2113 Australia
Country [1] 286824 0
Australia
Primary sponsor type
Government body
Name
SA Department of Health
Address
Citi Centre Building 11 Hindmarsh Square Adelaide South Australia 5000

Postal address: PO Box 287 Rundle Mall Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285614 0
None
Name [1] 285614 0
Address [1] 285614 0
Country [1] 285614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288890 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288890 0
Level 2
Room 2A221
Flinders Medical Centre
Bedford Park
SA
5042
Ethics committee country [1] 288890 0
Date submitted for ethics approval [1] 288890 0
Approval date [1] 288890 0
09/01/2013
Ethics approval number [1] 288890 0
365a.12

Summary
Brief summary
IBD is a complex condition, which is often associated with high morbidity and requires close and continued collaboration between patients, specialist medical care and other holistic, multi-disciplinary facilities. Despite multiple studies documenting differences in health outcomes between rural and urban patients in a number of diseases, little published data exists regarding the level of disease burden in rural patients with IBD and how this compares with what we know about urban populations. Additionally, limited knowledge regarding patient and rural practitioner perspectives on the barriers to optimal medical care exists. This is important as a large burden of disease exists outside of the metropolitan area, where specialist gastroenterology serves are absent and consequently the majority of long-term care is carried out by rural general practitioners and surgeons.

The aim of the study is to initially describe the disease burden and treatment experience of IBD, in patients living in rural areas as compared to metropolitan locations. We then aim to identify any perceived barriers to the care and management of patients with IBD in the rural setting compared with their urban counterparts from the perspective of rural practitioners, IBD nurses, surgeons and gastroenterologists. Finally we will obtain the patient perspective.

The study design is predominantly based upon questionnaires aimed at identifying rural practitioners IBD experience, level of IBD knowledge and perceived barriers. Perceived barriers will also be identified from a group of interested gastroenterologists and then all results will be compared to previously studies. Patients will then be surveyed to obtain their perceptions on barriers to care. Differences in healthcare outcomes will be looked at through review of a South Australian database and a new cohort in Mt Gambier and compared to a previously collected control.

This study will provide quantitative data and highlight any real differences in healthcare outcomes compared with metropolitan cohorts. It will then review knowledge of and attitude to IBD amongst several medical cohorts and finally investigate perceived barriers to care from a number of different perspectives. Through the data obtained we aim to identify common perceived barriers to optimal care, which may subsequently guide the development of multi-disciplinary interventions/strategies that could be introduced to enhance rural IBD patient care.

Given the current limited published data regarding this issue, it highlights an exciting opportunity to obtain such information to determine if and how interventions may be introduced that would aid in over-coming such obstacles and optimise care of this cohort in the long term.
Trial website
Trial related presentations / publications
Bennett AL, Wichmann M, Chin JK, Andrews, JM, Bampton PA. Rural Inflammatory Bowel Disease care in Australia: disease outcomes and perceived barriers to optimal care. Health Systems and Policy Research. 2015; 2 (1:18):1-10
Public notes
Attachments [1] 2917 2917 0 0
/AnzctrAttachments/363796-HSPR-2-18.pdf (Publication)

Contacts
Principal investigator
Name 38242 0
Dr Alice Bennett
Address 38242 0
Department of Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA
5042
Country 38242 0
Australia
Phone 38242 0
+61 4 288 30 979
Fax 38242 0
Email 38242 0
alice.bennett@health.sa.gov.au
Contact person for public queries
Name 38243 0
Dr Alice Bennett
Address 38243 0
Department of Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA
5042
Country 38243 0
Australia
Phone 38243 0
+61 8 8204 4964
Fax 38243 0
Email 38243 0
alice.bennett@health.sa.gov.au
Contact person for scientific queries
Name 38244 0
Dr Alice Bennett
Address 38244 0
Department of Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA
5042
Country 38244 0
Australia
Phone 38244 0
+61 8 8204 4964
Fax 38244 0
Email 38244 0
alice.bennett@health.sa.gov.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