Contact information
Type
Scientific
Primary contact
Dr M. Morren
ORCID ID
Contact details
Netherlands Institute for Health Services Research (NIVEL)
P.O. Box 1568
Utrecht
3500 BN
Netherlands
+31 (0)30 272 9700
m.morren@nivel.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PDS self-management
Study hypothesis
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
Received from the local medical ethics committee (Medisch Ethische Toetsingscommissie Academisch Ziekenhuis Maastricht) on the 21st December 2005 (ref: MEC 05-085).
Study design
Randomised, active controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/11/2006
Overall trial end date
01/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. IBS for at least three months
2. Age between 18 and 65 years
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Sufficient command of Dutch language
2. No visual handicap
3. Concomitant or previous psychotherapeutic treatment
Recruitment start date
01/11/2006
Recruitment end date
01/05/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Netherlands Institute for Health Services Research (NIVEL)
Utrecht
3500 BN
Netherlands
Sponsor information
Organisation
Netherlands Institute for Health Services Research (NIVEL) (The Netherlands)
Sponsor details
P.O. Box 1568
Utrecht
3500 BN
Netherlands
+31 (0)30 272 9700
receptie@nivel.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Dutch Digestive Diseases Foundation (Maag-Lever en Darm Stichting) (MLDS) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary