Dash 2015.
| Methods |
Study design: RCT Method of randomisation: computer‐generated table of random numbers. Setting: outpatient clinic of a referral teaching institute in India. Date it was conducted: June to December 2012. Follow up: 6 months. Source of funding: This study received no support in the form of grants, equipment, or drugs. Printing and publishing educational material funded by Center of Excellence Epilepsy, Department of Biotechnology, Ministry of Science and Technology, India. Conflict of interest:The authors declare no conflict of interest. |
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| Participants |
Includion/exclusion criteria: People diagnosed with epilepsy at least 1 month prior to the date of the study, ≥ 15 years of age, ability to understand Hindi/English, and willingness to participate in the study. Sample size: 180 participants were recruited. After a follow‐up of 6 months, 82 patients in IG and 70 in the CG completed the questionnaires. Gender: Male 52 (63%) in IG and 44 (63%) in CG Age: mean age was 34 years (SD 10.65) in IG and 35 years (SD 11.61) in CG. |
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| Interventions |
Type of intervention: Educational A one‐on‐one a structured format teaching administered by an epilepsy nurse in 4 sessions each lasting at least 30 mins.The teaching sessions covered the following domains: basic knowledge regarding epilepsy, myths and truths regarding epilepsy, diagnosis, treatment modalities (emphasis on compliance),living with epilepsy, and employment issues. Pamphlets written in Hindi and supplemented with illustrations and animations were also provided. The programme was developed by a group which included 3 epilepsy nurses, 2 epileptologist's and 2 social workers. |
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| Outcomes |
Primary outcome(s) measured: Adherence and self‐care. Adherence was assessed using the modified Morisky Medication Adherence Scale (MMAS). Secondary outcome(s) measured: the change in seizure frequency. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was done using a computer‐generated table of random numbers |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding was reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding was reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data are reported |
| Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes |
| Other bias | Low risk | The study seems to be free of other sources of bias |