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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR980 |
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Date of registration:
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21/05/2007 |
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Primary sponsor: |
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Public title:
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Stimulating self-management in irritable bowel syndrome through web-based interactive technology
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Scientific title:
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Stimulating self-management in irritable bowel syndrome through web-based interactive technology - PDS self-management |
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Date of first enrolment:
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1/11/2006 |
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Target sample size:
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60 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=980 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: [default]; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.
Morren |
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Address:
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NIVEL, Nederlands instituut voor onderzoek van de gezondheidszorg
Postbus 1568
3500 BN
Utrecht
The Netherlands |
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Telephone:
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+31 30-2729700 |
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Email:
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m.morren@nivel.nl |
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Affiliation:
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Name:
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M.
Morren |
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Address:
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NIVEL, Nederlands instituut voor onderzoek van de gezondheidszorg
Postbus 1568
3500 BN
Utrecht
The Netherlands |
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Telephone:
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+31 30-2729700 |
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Email:
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m.morren@nivel.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. IBS for at least three months;
2. Age between 18 and 65 years
Exclusion criteria: 1. sufficient command of Dutch language
2. No visual handicap
3. Concomitant or previous psychotherapeutic treatment
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Selfmanagement, Irritable bowel syndrome, Information and communication technology, Irritable bowel syndrome (IBS)
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Intervention(s)
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Standard care (control condition) + 4 daily electronic diaries during 5 weeks following ABA design (experimental condition):
- 1 week baseline
- a psychologist on 4 daily diaries
- 1 week follow-up
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Primary Outcome(s)
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IBS-severity, measured by
1. IBS Rome III criteria list
2. abdominal pain
3. secondary gastrointestinal complaints (diarrhea, constipation, flatulence, belching, abdominal rumbling and distension)
All administered at baseline and at 12 weeks; all except (1) also at 5 weeks
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Secondary Outcome(s)
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1. Quality of life (IBS Quality of Life)
2. Daily functioning (SF-12)
3. Cognitions (Cognitive Scale ? Functional Bowel Disorders)
4. Pijnattributies (Pain Cognition Scale)
All administered at baseline (0 weeks), 5 weeks, and 12 weeks.
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Secondary ID(s)
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ISRCTN09185998
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Source(s) of Monetary Support
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Maag Lever Darm Stichting (MLDS)
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