Stimulating self-management in irritable bowel syndrome through web-based interactive technology
ISRCTN | ISRCTN09185998 |
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DOI | https://doi.org/10.1186/ISRCTN09185998 |
Secondary identifying numbers | NL954 (NTR980) |
- Submission date
- 27/06/2007
- Registration date
- 27/06/2007
- Last edited
- 27/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M. Morren
Scientific
Scientific
Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands
Phone | +31 (0)30 272 9700 |
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m.morren@nivel.nl |
Study information
Study design | Randomised, active controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Quality of life |
Scientific title | Stimulating self-management in irritable bowel syndrome through web-based interactive technology |
Study acronym | PDS self-management |
Study objectives | Immediate, situational feedback is more effective than standard care alone, which, according to the Dutch Irritable Bowel Syndrome (IBS) Guideline of General Practice (Dutch College of General Practitioners [NHG], 2001), includes education, dietary advice and reassurance about the benign course of the disease. |
Ethics approval(s) | Received from the local medical ethics committee (Medisch Ethische Toetsingscommissie Academisch Ziekenhuis Maastricht) on the 21st December 2005 (ref: MEC 05-085). |
Health condition(s) or problem(s) studied | Self-management of irritable bowel syndrome |
Intervention | Standard care (control condition) and four daily electronic diaries during five weeks following ABA design (experimental condition): 1. One week baseline 2. A psychologist on four daily diaries 3. One week follow-up |
Intervention type | Other |
Primary outcome measure | IBS-severity, measured by: 1. IBS Rome III criteria list 2. Abdominal pain 3. Secondary gastrointestinal complaints (diarrhoea, constipation, flatulence, belching, abdominal rumbling and distension) All administered at baseline and at 12 weeks; all except (1), which is also measured at five weeks. |
Secondary outcome measures | 1. Quality of life (IBS Quality of Life) 2. Daily functioning (12-item Short Form health survey [SF-12]) 3. Cognitions (Cognitive Scale - Functional Bowel Disorders) 4. Pain attributes (Pain Cognition Scale) All administered at baseline (0 weeks), 5 weeks, and 12 weeks. |
Overall study start date | 01/11/2006 |
Completion date | 01/05/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 60 |
Key inclusion criteria | 1. IBS for at least three months 2. Age between 18 and 65 years |
Key exclusion criteria | 1. Sufficient command of Dutch language 2. No visual handicap 3. Concomitant or previous psychotherapeutic treatment |
Date of first enrolment | 01/11/2006 |
Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands
3500 BN
Netherlands
Sponsor information
Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Research organisation
Research organisation
P.O. Box 1568
Utrecht
3500 BN
Netherlands
Phone | +31 (0)30 272 9700 |
---|---|
receptie@nivel.nl | |
Website | http://www.nivel.nl/ |
https://ror.org/015xq7480 |
Funders
Funder type
Research organisation
Dutch Digestive Diseases Foundation (Maag-Lever en Darm Stichting) (MLDS) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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 | Not provided at time of registration |
Editorial Notes
27/10/2021: Proactive update review. No publications found. Search options exhausted.