Ozgursoy Uran 2019.
Study characteristics | ||
Methods | RCT Setting: single centre, gastroenterology unit in Turkey Study period: NS The study presents results for the IBD cohort as a whole, does not separate between CD and UC. Where separate data do exist they are presented below. |
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Participants |
Inclusion criteria: diagnosed with IBD at least 6 months ago, able to use computer, Internet, and mobile phone, 18 years of age and over Exclusion criteria: patients with advanced comorbid diseases such as cancer, diabetes, chronic obstructive pulmonary disease, hypertension were excluded from the study since symptoms, disease activity, and quality of life would be affected at a different level. Age (mean ± SD): IG: 37.26 (12.99) CG: 41.63 (11.85) Sex (M/F): IG: 17/13 CG: 18/12 Site of disease: NS Use of concurrent medication: NS Disease activity: mix of active and inactive; the Mayo Score was used for UC and the HBI for CD Disease duration: IG: n = 7 (less than 36 months); n = 12 (less than 71 months); n = 11 (greater than 72 months) CG: n = 10 (less than 36 months); n = 6 (less than 71 months); n = 14 (greater than 72 months) Number randomised: IG: 30 (UC: 16, CD: 14); CG: 30 (UC: 16, CD: 14) Number reaching end of study: IG: 30; CG: 30 Number analysed: IG: 30; CG: 30 Postrandomisation exclusion: IG: 0; CG: 0 |
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Interventions |
IG: 8 weeks of web‐based education about UC and CD CG: 8 weeks of standard book‐based education about UC and CD The content and scope of the web‐based and standard education programmes carried out with IBD patients were prepared by the researcher to be exactly the same in line with the literature. Definitions, anatomy, and physiology, indications, diagnostic tests, treatment principles, the importance of drug use, nutritional principles, and specific descriptions for special cases such as pregnancy, sexuality, and puberty are included in the content of the education. A website was designed for the web‐based education group, and all information was presented to the user with different interfaces. The standard education group received education via easy‐to‐read, illustrated, colour‐printed books. |
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Outcomes |
Length of intervention: 8 weeks Primary outcomes: Pain intensity was measured using VAS scoring system. Participants were asked to rate symptoms experienced in the last 3 months as "0 None" and "10 unendurable". Any reduction in scores was considered a success Withdrawal due to adverse events Secondary outcomes: Serious adverse events |
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Notes | Funding source: The authors declare no financial support. Conflicts of interest: The authors declare no conflicts of interest. Author contact details: bernanilgun@gmail.com |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | According to author correspondence, randomisation was done using a simple stratified randomisation method. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. We contacted the authors but received no response. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible for this type of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | According to author correspondence, the analysis was done by a blinded biostatistics specialist. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcomes are presented in the results. |
Selective reporting (reporting bias) | Low risk | All outcomes are presented in the results. |
Other bias | Low risk | No conflicts of interest, and baseline characteristics were balanced between groups |