Condition category
Digestive System
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
03/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nivel.nl/

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

Publication citations

Additional files

Editorial Notes