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E-Patient Counseling trial


- candidate number22829
- NTR NumberNTR5475
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2015
- Secondary IDs2015-1742 CMO Arnhem-Nijmegen
- Public TitleE-Patient Counseling trial
- Scientific TitleE-Patient Counseling Trial
- ACRONYME-PACO
- hypothesisIs computer assisted instruction non-inferior to traditional nurse counseling as modality in patient education prior to colonoscopy in bowel cleanliness during endoscopy?
- Healt Condition(s) or Problem(s) studiedEndoscopy, Coloscopy, Patient education
- Inclusion criteriaReferral for colonoscopy, age > 18 years
- Exclusion criteriaDutch illiteracy, audiovisual and mental handicaps.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-sep-2015
- planned closingdate1-mrt-206
- Target number of participants1000
- InterventionsComputer Based Instruction at home
- Primary outcomeBowel Cleanliness during colonoscopy
- Secondary outcomeHealth Literacy
Anxiety
Comprehension
Cost-Effectiveness
- TimepointsMeasurement after education, prior and after colonoscopy
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD Govert Veldhuijzen
- CONTACT for SCIENTIFIC QUERIESMD Govert Veldhuijzen
- Sponsor/Initiator Radboud University Medical Center Nijmegen, Jeroen Bosch Hospital, Medisch Centrum Alkmaar
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryBACKGROUND Patient education prior to colonoscopy has become more complex. Current common practice is nurse counselling, which improves adherence to instructions for bowel preparation. This is costly and has disadvantages regarding uniformity and time consumption for both patient and the hospital. We hypothesized that computer based instruction supported by video and 3D animations can replace nurse counselling in most cases, without losing quality of bowel cleanliness during colonoscopy.

METHODS/DESIGN We choose a randomized controlled trial design, endoscopist blinded, to evaluate our primary outcome measure cleanliness of the bowels during colonoscopy. Secondary outcome measures were patient anxiety after instruction and prior to colonoscopy, patient satisfaction and cost effectiveness.

We used head-to-head randomization in three endoscopy units, including different levels (rural, urban, tertiary). Inclusion criteria were adult age and referral for complete colonoscopy. Exclusion criteria were Dutch illiteracy, audiovisual or mental handicaps.
Power calculation was performed, based on a non-inferiory calculation of clinically relevant differences in bowel preparation, using the Boston Bowel Preparation Scale, resulting in 500 patients per group, 1000 patients in total.

DISCUSSION The aim of this trial is to establish the position of online computer based counseling as tool for the education of patients prior to colonoscopy. By choosing a direct comparison with the standard of care, being nurse counseling, both endoscopic quality measures and patient related outcome measures can be evaluated.
- Main changes (audit trail)
- RECORD4-sep-2015 - 23-dec-2015


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