Towards appropriate outpatient follow-up of patients with chronic disease
| ISRCTN | ISRCTN25364353 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25364353 |
| Secondary identifying numbers | PSI05-11 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John Williams
Scientific
Scientific
School of Postgraduate Studies in Medical & Health Care
Maes-y-Gwernen Hall
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
| Phone | +44 (0)1792 703531 |
|---|---|
| John.williams@pgms.wales.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | OPFUS |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/07/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 180 |
| Key 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 |
| Key exclusion criteria | 1. Active disease requiring treatment 2. Stoma 3. Other disease which required regular follow up 4. Unable to comply with data collection |
| Date of first enrolment | 01/04/1995 |
| Date of final enrolment | 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
SA6 6NL
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/02/2000 | Yes | No |
