Randomised controlled trial to assess the impact of a package comprising a patient orientated, evidence based self-help guidebook and patient-centred consultations on disease management and satisfaction in inflammatory bowel disease
| ISRCTN | ISRCTN18598681 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18598681 |
| Protocol serial number | HTA 96/11/02 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 08/11/2022
- 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
Dr Anne Kennedy
Scientific
Scientific
National Primary Care Research & Development Centre
University of Manchester
5th Floor
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 275 7620 |
|---|---|
| akennedy@fs1.cprc.man.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial to assess the impact of a package comprising a patient orientated, evidence based self-help guidebook and patient-centred consultations on disease management and satisfaction in inflammatory bowel disease |
| Study objectives | To determine if an expensive, comprehensive guidebook promoting patient choice combined with physicians trained in patient-centred care and use of the guidebook improves patient satisfaction, health, quality of life, perceptions of control, anxiety levels, ability to self-treat and leads to cost effective use of NHS services. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Inflammatory bowel disease |
| Intervention | A multi-centre (16 centres, 40 subjects from each centre, 640 in total) 2-armed RCT, comparing benefits of guidebook plus patient-centred care versus standard patient care using validated questionnaires, patients diaries and qualitative interviews with patients and clinicians. 1. Guidebook plus patient-centred care 2. Standard patient care using validated questionnaires, patients diaries and qualitative interviews with patients and clinicians. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Patient satisfaction |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 640 |
| Key inclusion criteria | 1. Established ulcerative colitis or Crohn's disease 2. 16 years + 3. Able to write English 4. Attending follow-up clinics |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 31/12/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
National Primary Care Research & Development Centre
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | HTA monograph | 01/02/2003 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/11/2022: Internal review.
