DePue 2013.
| Study characteristics | ||
| Methods |
Nurse‐community health worker team improves diabetes care in American Samoa Cluster‐RCT (12 clusters), conducted in Tafuna Clinic of the AS Community Health Centers, Department of Health, AS Government, USA Two arms: 1. Usual care (control arm) and 2. Community health worker (intervention arm) |
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| Participants | Control arm N: 164 Intervention arm N: 104 Diabetes type: type 2 Mean age: 55.0 ± 12.7 % Male: 38.0 Longest follow‐up: 12 months |
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| Interventions |
Control arm: 1) Clinician education 2) Patient education Intervention arm: 1) Case management 2) Team changes 3) Clinician education 4) Patient education 5) Promotion of self‐management 6) Patient reminders |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 10.0 (2.3), post 10.0 (2.3) Intervention arm: pre 9.6 (2.1), post 9.3 (2.0) |
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| Funding source | This project was funded by the National Institute of Diabetes, Digestive, and Kidney Disorders (R18‐DK075371) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. |
| Allocation concealment (selection bias) | Low risk | Not reported but since cluster, low risk. |
| Provider's baseline characteristics (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Text: alcohol, physical activity, but not provided in table. |
| Patient's baseline outcomes (selection bias) | Unclear risk | Not reported. |
| Incomplete outcome data (attrition bias) | Low risk | 10% lost to follow‐up in usual care group; 9% lost to follow‐up in control group; reasons seem balanced between groups. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: HbA1c, DCA 2000 Analyzer, SBP using 3 measurements, standard American Heart Association protocol. |
| Selective reporting (reporting bias) | High risk | Some secondary outcomes listed in protocol, not in paper. |
| Risk of contamination (other bias) | Low risk | Cluster. |
| Other bias | Low risk | Information not available. |