Uran 2019.
Study characteristics | ||
Methods |
Study design: prospective RCT Study duration: 8 weeks Setting: gastroenterology polyclinic |
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Participants |
State of disease at beginning of study per IG/CG: At baseline: N (%) disease activity of UC: Remission IG (web‐based education): 5 (31.3%); CG (standard education): 4 (25.0%) N (%) disease activity of CD: Remission IG (web‐based education): 5 (35.6%); CG (standard education): 9 (64.3%) Disease type per IG/CG: IG (web‐based education): 16 UC and 14 CD CG (standard education): 16 UC and 14 CD Inclusion criteria: people were diagnosed with IBD at least six months previously, able to use computer, Internet and mobile phone and aged 18 years and over. Exclusion: people with advanced comorbid diseases such as cancer, diabetes, chronic obstructive pulmonary disease, hypertension Age at beginning of study per IG/CG: Mean (unspecified type of variation): IG (web‐based education): 37.26 (± 12.99) CG (standard education): 41.63 (± 11.85) Sex per IG/CG: Numbers in IG (web‐based education): 13/30 females and 17/30 males Numbers in CG (standard education): 12/30 females and 18/30 males Disease duration per IC/CG: mean (SD) months IG: 82.23 (54.52); CG: 81.93 (56.71) Number randomised per IG/CG: IG (web‐based education): 30; CG (standard education): 30 Number reaching end of study per IG/CG IG (web‐based education): 30; CG (standard education): 30 |
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Interventions |
IG(web‐based education): information presented via online web‐site CG (standard education): information presented via easy‐to‐read, illustrated, colour‐printed books Both group had exactly the same educational content that differed only in mode of delivery |
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Outcomes |
Duration of follow‐up: NR Primary outcomes as defined by study authors: the effect of web‐based education on disease activity, symptom management and quality of life Secondary outcomes as defined by study authors: NR |
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Notes |
Funding source: the authors declared no financial supports Conflicts of interest: the authors declared no conflict of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Simple randomisation and stratified randomisation were made separately according to the criteria of age, gender, educational level and duration of disease. Randomisation was made by a statistician. Author was contacted, no response received. |
Allocation concealment (selection bias) | Unclear risk | No details. Author was contacted, no response received. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The researcher was blinded to the randomisation process but participants knew which treatment they received |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No mention of any outcome assessment blinding. Author was contacted, no response received. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No patient flow details given. Author was contacted, no response received. |
Selective reporting (reporting bias) | Unclear risk | No protocol/trial registration. Appropriate outcomes reported as per the method section |
Other bias | Low risk | No baseline imbalance. No other concerns. |