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


- candidate number2591
- NTR NumberNTR980
- ISRCTNISRCTN09185998
- Date ISRCTN created27-jun-2007
- date ISRCTN requested11-jun-2007
- Date Registered NTR21-mei-2007
- Secondary IDs 
- Public TitleStimulating self-management in irritable bowel syndrome through web-based interactive technology
- Scientific TitleStimulating self-management in irritable bowel syndrome through web-based interactive technology
- ACRONYMPDS self-management
- hypothesisImmediate, situational feedback is more effective than standard care alone, which, according to the Dutch IBS Guideline of General Practice (NHG, 2001), includes education, dietary advices and reassurance about the benign course of the disease.
- Healt Condition(s) or Problem(s) studiedSelfmanagement, Irritable bowel syndrome, Information and communication technology, Irritable bowel syndrome (IBS)
- Inclusion criteria1. IBS for at least three months; 2. Age between 18 and 65 years
- Exclusion criteria1. sufficient command of Dutch language 2. No visual handicap 3. Concomitant or previous psychotherapeutic treatment
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- group[default]
- Type-
- Studytypeintervention
- planned startdate 1-nov-2006
- planned closingdate1-mei-2008
- Target number of participants60
- InterventionsStandard 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
- Primary outcomeIBS-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
- Secondary outcome1. 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.
- Timepoints
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M. Morren
- CONTACT for SCIENTIFIC QUERIESDr. M. Morren
- Sponsor/Initiator Nederlands instituut voor onderzoek van de gezondheidszorg (NIVEL)
- Funding
(Source(s) of Monetary or Material Support)
Maag Lever Darm Stichting (MLDS)
- Publications-Dulmen AM van, Fennis JFM, Mokkink HGA, Velden HGM van der, Bleijenberg G. Doctors' perception of patients' cognitions and complaints in irritable bowel syndrome at an out-patient clinic. J Psychosom Res 1994; 38: 581-590 -Dulmen AM van, Fennis JFM, Mokkink HGA, Velden HGM van der, Bleijenberg G. Doctor-dependent changes in complaint-related cognitions and anxiety during medical consultations in functional abdominal complaints. Psychol Med 1995; 25: 1011-1018 -Dulmen AM van, Fennis JFM, Mokkink HGA, Bleijenberg G. The relationship between complaint-related cognitions in referred patients with irritable bowel syndrome and subsequent health care seeking behaviour in primary care. Fam Pract 1996a; 13: 12-17 -Dulmen AM van, Fennis JFM, Bleijenberg G. Cognitive-behavioural group therapy for irritable bowel syndrome: effects and long-term follow-up. Psychosom Med 1996b; 58: 501-514 -Dulmen AM van, Fennis JFM, Mokkink HGA, Velden HGM van der, Bleijenberg G. Persisting improvement in complaint-related cognitions initiated during medical consultations in functional abdominal complaints. Psychol Med 1997; 27: 725-729 -Heitkemper MM, Jarrett ME, Levy RL, Cain KC, Burr RL, Feld A, Barney P, Weisman P. Self-management for women with irritable bowel syndrome. Clin Gastroenterol Hepatol 2004; 2: 585-596 -Horst HE van der, Dulmen AM van, Schellevis FG, Eijk van JThM, Fennis JFM, Bleijenberg G. Do patients with irritable bowel syndrome in primary care really differ from outpatients with irritable bowel syndrome? Gut 1997; 41: 669-674 -Horst HE van der, Schellevis FG, Eijk van JthM, Bleijenberg G. Managing patients with irritable bowel syndrome in general practice: how to promote and reinforce self-care activities. Patient Educ Couns 1998; 35: 149-156 -Kruise DA, Sorbi MJ, Bensing JM, van Dulmen AM, Spreeuwenberg PMM. Electronic guidance of behavior relevant to migraine: a pilot in low-back pain. In: Couturier EGM, Sorbi MJ (eds). Headache and Migraine. Anglo Dutch Migraine Association, Utrecht, 2004 -Peters ML, Sorbi MJ, Kruise DA, Kerssens JJ, Verhaak PF, Bensing JM. Electronic diary assessment of pain, disability and psychological adaptation in patients differing in duration of pain. Pain 2000; 84: 181-92.
- Brief summaryThis study aims to establish the effectiveness of situational feedback to the self-management of IBS using a web-based intervention. The feedback focuses on opposing well-known features of inadequate self-management in IBS: catastrophic cognitions, somatic attributions and avoidance behaviour. It is hypothesized that this intervention improves cognitive and behavioural coping and complaint severity more than standard care (i.e., education, diet, reassurance) alone. Sixty IBS patients are recruited through their GP and randomized into the experimental or standard GP care group. For 5 weeks, experimental patients receive a palmtop computer which prompts them at 4 (random) instances a day to complete questions on complaint severity and cognitive and behavioural coping. Data are immediately transferred to a psychologist and serve to generate telemedicine feedback twice daily during week 2-4. All patients complete questionnaires at baseline, five weeks and three months.
- Main changes (audit trail)
- RECORD21-mei-2007 - 3-jul-2007


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