Gary 2003.
| Study characteristics | ||
| Methods |
Randomized controlled trial of the effects of nurse case manager and community health worker interventions on risk factors for diabetes‐related complications in urban African Americans Patient RCT, conducted in a university ambulatory clinic serving inner‐city population in Baltimore, MD, USA Four arms: 1. Usual care (control arm), 2. NCM ‐ nurse case manager (intervention arm 1), 3. CHW ‐ community health worker (intervention arm 2) and 4. NCM/CHW (intervention arm 3) |
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| Participants | Control arm N: 34 Intervention arm 1 N: 38 Intervention arm 2 N: 41 Intervention arm 3 N: 36 Diabetes type: type 2 Mean age: 59.0 ± 9.0 % Male: 23.0 Longest follow‐up: 24 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm 1: 1) Case management 2) Patient education Intervention arm 2: 1) Case management 2) Patient education Intervention arm 3: 1) Case management 2) Team changes 3) Patient education |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.5 (2.0), post 8.5 (NR) Intervention arm 1: pre 8.8 (2.2), post 8.5 (NR) Intervention arm 2: pre 8.4 (2.0), post 8.1 (NR) Intervention arm 3: pre 8.6 (1.9), post 7.8 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 127.0 (20.0), post 127.0 (NR) Intervention arm 1: pre 125.0 (15.0), post 131.3 (NR) Intervention arm 2: pre 129.0 (20.0), post 125.7 (NR) Intervention arm 3: pre 129.0 (14.0), post 127.4 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 78.0 (11.0), post 78.0 (NR) Intervention arm 1: pre 75.0 (12.0), post 75.0 (NR) Intervention arm 2: pre 75.0 (11.0), post 72.0 (NR) Intervention arm 3: pre 76.0 (15.0), post 71.0 (NR) 4) LDL, mean mg/dL (SD) Control arm: pre 135.0 (33.0), post 118.3 (NR) Intervention arm 1: pre 138.0 (39.0), post 144.0 (NR) Intervention arm 2: pre 149.0 (43.0), post 155.0 (NR) Intervention arm 3: pre 132.0 (36.0), post 136.0 (NR) |
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| Funding source | This work was supported by grants from the National Institutes of Health (R01‐DK48117‐04, R01‐DK48117‐03S1, T32‐HL07024) and the Johns Hopkins University Outpatient Department General Clinical Research Center (R00052) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Information not available. |
| Allocation concealment (selection bias) | Low risk | Information not available. |
| Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
| Patient's baseline outcomes (selection bias) | High risk | Information not available. |
| Incomplete outcome data (attrition bias) | Low risk | Information not available. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Information not available. |
| Selective reporting (reporting bias) | Low risk | Information not available. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |