ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inflammatory Bowel Disease

Condition category

Condition code

Oral and Gastrointestinal

Inflammatory bowel disease

Public Health

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]

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]

Disease burden/IBD health outcomes of rural IBD patients will be assessed through a once off questionnaire.

Timepoint [1]

1 questionnaire at the beginning of the study period. (ie as soon as the participant has consented to the study).

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

5/03/2013

Actual

5/03/2013

Date of last participant enrolment

Anticipated

Actual

31/12/2013

Date of last data collection

Anticipated

Actual

1/07/2014

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

5290 - Mount Gambier

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Janssen

Address [1]

Address:
1-5 Khartoum Rd, North Ryde NSW 2113 Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Clinical Human Research Ethics Committee

Ethics committee address [1]

Level 2
Room 2A221
Flinders Medical Centre
Bedford Park
SA
5042

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

09/01/2013

Ethics approval number [1]

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]

/AnzctrAttachments/363796-HSPR-2-18.pdf (Publication)

Contacts

Principal investigator

Name

Dr Alice Bennett

Address

Department of Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA
5042

Country

Australia

Phone

+61 4 288 30 979

Fax

alice.bennett@health.sa.gov.au

Contact person for public queries

Name

Alice Bennett

Address

Department of Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA
5042

Country

Australia

Phone

+61 8 8204 4964

Fax

alice.bennett@health.sa.gov.au

Contact person for scientific queries

Name

Alice Bennett

Address

Department of Gastroenterology
Flinders Medical Centre
Flinders Drive
Bedford Park SA
5042

Country

Australia

Phone

+61 8 8204 4964

Fax

alice.bennett@health.sa.gov.au

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.

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