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

ISRCTN	ISRCTN09185998
DOI	https://doi.org/10.1186/ISRCTN09185998
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	NL954 (NTR980)
Sponsor	Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Funder	Dutch Digestive Diseases Foundation (Maag-Lever en Darm Stichting) (MLDS) (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised, active controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

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

Editorial Notes

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