Stimulating self-management in irritable bowel syndrome through web-based interactive technology

ISRCTN ISRCTN09185998
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

Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands

Phone +31 (0)30 272 9700
Email m.morren@nivel.nl

Study information

Study designRandomised, active controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific titleStimulating self-management in irritable bowel syndrome through web-based interactive technology
Study acronymPDS self-management
Study objectivesImmediate, 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) studiedSelf-management of irritable bowel syndrome
InterventionStandard 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 typeOther
Primary outcome measureIBS-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 measures1. 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 date01/11/2006
Completion date01/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants60
Key inclusion criteria1. IBS for at least three months
2. Age between 18 and 65 years
Key exclusion criteria1. Sufficient command of Dutch language
2. No visual handicap
3. Concomitant or previous psychotherapeutic treatment
Date of first enrolment01/11/2006
Date of final enrolment01/05/2008

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands

Sponsor information

Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Research organisation

P.O. Box 1568
Utrecht
3500 BN
Netherlands

Phone +31 (0)30 272 9700
Email receptie@nivel.nl
Website http://www.nivel.nl/
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Editorial Notes

27/10/2021: Proactive update review. No publications found. Search options exhausted.