Khan 2011 ‐ African Ameri.
| Methods |
Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 67 intervention:62 control Superiority design |
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| Participants |
Inclusion criteria:
Exclusion criteria: none stated Diagnostic criteria: not stated |
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| Interventions |
Number of study centres: 1 Treatment before study: does not say Intervention: was the 'Living Well with Diabetes Multimedia Program.' Aim of the intervention was to improve participants' diabetes self‐management behaviours, therapy intensification and glycaemic control over a 3‐month period 19 bilingual computer multimedia lessons on diabetes self‐management: Content included an introduction to diabetes, blood glucose management, oral medications and insulin, nutrition and physical activity, depression and stress and oral hygiene, and prevention of complications (eye, foot, cardiovascular, kidney diseases). Each lesson targeted a specific self‐care objective. The programme also consisted of more than 160 testimonials from African American and Hispanic patients with diabetes related to diabetes self‐care, emphasising barriers to care, challenges and personalised solutions that they or family members had encountered. Different testimonials and messages were used to relate both language and culturally appropriate information to African American or Latino users Programme available to patients in waiting areas, prior to attending general education. Each lesson targeted a specific objective according to Gagne's theory of learning and the component display theory Control: given an American Diabetes Association brochure on self‐management ("Living with Diabetes," written at 6th grade level) Co‐interventions: All participants received traditional diabetes self‐management education. This involved group educational sessions, individualised risk assessment and goal setting |
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| Outcomes | Outcomes reported in abstract of publication: diabetes knowledge, self‐efficacy, behaviours, medications prescribed, HbA1c and BP levels over 3 months | |
| Study details |
Run‐in period: none stated Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: Agency for Healthcare Research and Quality Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "to evaluate the impact of a waiting room‐administered, low‐literacy, computer multimedia diabetes education program on patient self‐management and provider intensification on therapy" | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random allocation by research assistant pulling a card out of a box, with each card indicating group assignment |
| Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: participants not blinded because of the nature of the study, but physicians were blinded |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: participants not blinded because of the nature of the study, but physicians were blinded |
| Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Unclear risk | Comment: does not say whether research assistants were blinded. Physicians were blinded |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Comment: participants not blinded completing questionnaires |
| Incomplete outcome data (attrition bias) Objective outcomes | Low risk | Comment: 12/129 lost to follow‐up, roughly equal in control/intervention group. Reasons for dropping out included relocation, phone disconnection and leaving the county health system |
| Incomplete outcome data (attrition bias) Subjective outcomes | Low risk | Comment: 12/129 lost to follow‐up, roughly equal in control/intervention group. Reasons for dropping out included relocation, phone disconnection and leaving the county health system |
| Selective reporting (reporting bias) | Unclear risk | Comment: study protocol not seen |
| Other bias | Unclear risk | Comment: none |