DiIorio 2009.
Study characteristics | ||
Methods |
Study design: RCT Method of randomisation: not reported Setting: 3 clinics in a large south‐eastern metropolitan area of the USA Date it was conducted: not reported Follow‐up: 12 weeks Source of funding: Emory University Research Committee Conflict of interest: not reported |
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Participants |
Inclusion/exclusion criteria:≥ 18 years, were able to understand and speak English, had telephone access and were mentally stable Sample size: 22 Gender: 15 were men (68.2%) Age: mean age was 43 years (SD 13.51) |
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Interventions |
Type of intervention: behavioural 5 motivational intervention sessions were conducted: 1 face‐to‐face and 4 telephone‐based. For each session, a specially trained nurse used a script that included key aspects of self‐management and discussed medication management with the participant. The nurse began by asking a general question about medication‐taking practices.Those who reported problems with medication were provided support. A goal and action plan of at least one strategy to improve adherence was developed. Participants were encouraged to develop their own solutions and to devise an action plan. Then, the nurse asked the participant to select 1 or 2 other self‐management components (information, seizure, safety and lifestyle issues) that were important to him or her. The rest of discussion aimed at identifying barriers and facilitators of desired behaviours, eliciting change strategies and building confidence. |
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Outcomes |
Primary outcome(s) measured: adherence It was measured via MEMS cap (presented as percentage of doses taken and percentage of doses taken on time), and self‐reported adherence by using AGAS. Secondary outcome(s) measured: outcome expectancy (a judgement of the likely consequences of practising self‐management strategies and epilepsy self‐management), self‐efficacy and knowledge of epilepsy (medical and social aspects). |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of randomisation was not reported |
Allocation concealment (selection bias) | Unclear risk | No information on concealment was reported |
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 | Unclear risk | Insufficient reporting of attrition/exclusions to permit judgement |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | High risk | Inadequate sample size could increase the likelihood of a type II error and other bias |