Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Inflammatory bowel disease
Intervention
1. Open access follow-up in outpatients
2. Standard care
Intervention type
Other
Primary outcome measure
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 study start date
01/04/1995
Overall study end date
01/07/1999
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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, Wales
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/02/2000 | Yes | No |