Bogner 2012.
| Study characteristics | ||
| Methods |
Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial Patient RCT, conducted with patients recruited from 3 primary care practices in Philadelphia, Pennsylvania. Study was conducted in a clinical setting. In USA. Two arms: 1) Usual care (control arm) and 2) Intervention (intervention arm) |
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| Participants | Control arm N: 88 Intervention arm N: 94 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 3 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 7.0 (1.9), post 7.5 (NR) Intervention arm: pre 7.2 (1.8), post 6.5 (NR) |
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| Funding source | This work was supported by American Diabetes Association Clinical Research Award 1‐09‐CR‐07. Dr Bogner was supported by NIMH grant MH082799 and MH047447. Dr Morales was supported by a NIMH‐mentored Career Development Award (MH073903). | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "…were randomized within each practice by flip of a coin…" |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
| Patient's baseline outcomes (selection bias) | Low risk | Quote: "HbA1c (P = 0.51)" |
| Incomplete outcome data (attrition bias) | High risk | Only 2 lost to follow‐up in intervention group ~2% |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | HbA1c methods described. Assessors were blinded, physicians blinded to those randomised to usual care. |
| Selective reporting (reporting bias) | Low risk | Checked protocol and everything proposed was completed. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |