|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN25364353 |
|
Date of registration:
|
23/01/2004 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Towards appropriate outpatient follow-up of patients with chronic disease
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
01/04/1995 |
|
Target sample size:
|
180 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN25364353 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
John
Williams |
|
Address:
|
School of Postgraduate Studies in Medical & Health Care
Maes-y-Gwernen Hall
Morriston Hospital
SA6 6NL
Swansea
United Kingdom |
|
Telephone:
|
+44 (0)1792 703531 |
|
Email:
|
John.williams@pgms.wales.nhs.uk |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Exclusion criteria: 1. Active disease requiring treatment
2. Stoma
3. Other disease which required regular follow up
4. Unable to comply with data collection
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Inflammatory bowel disease
Digestive System
Other noninfective gastroenteritis and colitis
|
|
Intervention(s)
|
1. Open access follow-up in outpatients
2. Standard care
|
|
Primary Outcome(s)
|
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(s)
|
|
No secondary outcome measures
|
|
Source(s) of Monetary Support
|
|
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|