Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Williams

ORCID ID

Contact details

School of Postgraduate Studies in Medical & Health Care
Maes-y-Gwernen Hall
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
+44 (0)1792 703531
John.williams@pgms.wales.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PSI05-11

Study information

Scientific title

Acronym

OPFUS

Study hypothesis

The aim of the study was to evaluate open access as a means of following-up patients with chronic, relapsing, inflammatory bowel disease. The study sought to establish the clinical impact and cost effectiveness of open access follow-up in outpatients of patients with chronic disease, using inflammatory bowel disease as the exemplar.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Inflammatory bowel disease

Intervention

1. Open access follow-up in outpatients
2. Standard care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Generic (36-item Short Form Health Survey [SF-36]) and disease-specific (UK Inflammatory Bowel Disease Questionnaire [UKIBDQ]) quality of life measured at six-monthly intervals for two years
2. Number of primary and secondary care contacts
3. Total resource use
4. Views of patients and general practitioners (GPs)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/1995

Overall trial end date

01/07/1999

Reason abandoned

Eligibility

Participant inclusion criteria

180 adult patients (78 Crohn's disease, 77 ulcerative or indeterminate colitis, 25 ulcerative or idiopathic proctitis recruited from outpatient clinics between October 1995 and November 1996:
1. Aged over 18 years, either sex
2. Inactive or mildly active but stable inflammatory bowel disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Active disease requiring treatment
2. Stoma
3. Other disease which required regular follow up
4. Unable to comply with data collection

Recruitment start date

01/04/1995

Recruitment end date

01/07/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Postgraduate Studies in Medical & Health Care
Swansea
SA6 6NL
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10688560

Publication citations

  1. Results

    Williams JG, Cheung WY, Russell IT, Cohen DR, Longo M, Lervy B, Open access follow up for inflammatory bowel disease: pragmatic randomised trial and cost effectiveness study., BMJ, 2000, 320, 7234, 544-548.

Additional files

Editorial Notes