Krein 2004.
| Study characteristics | ||
| Methods |
Case management for patients with poorly controlled diabetes: a randomized trial Patient RCT, conducted in Department of Veterans Affairs Medical Centres, USA Two arms: 1. Control (control arm) and 2. Case management (intervention arm) |
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| Participants | Control arm N: 123 Intervention arm N: 123 Diabetes type: type 2 Mean age: 61.0 ± 10.5 % Male: 96.5 Longest follow‐up: 19 months (mean) |
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| Interventions |
Control arm: 1) Patient education 2) Promotion of self‐management Intervention arm: 1) Case management 2) Patient education 3) Promotion of self‐management 4) Patient reminders |
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| Outcomes | 1) Aspirin, N users (%) Control arm: pre 68 (55), post 64 (60) Intervention arm: pre 77 (63), post 78 (71) 2) Statins, N users (%) Control arm: pre 29 (24), post 40 (39) Intervention arm: pre 35 (28), post 51 (48) 3) Retinopathy screening (eye exam), N screened (%) Control arm: pre 83 (67), post 84 (79) Intervention arm: pre 94 (76), post 96 (87) 4) HbA1c, mean % (SD) Control arm: pre 9.2 (1.4), post 9.2 (2.1) Intervention arm: pre 9.3 (1.5), post 9.3 (2.1) 5) SBP, mean mmHg (SD) Control arm: pre 145.0 (20.0), post 144.0 (23.3) Intervention arm: pre 145.0 (21.0), post 146.0 (23.6) 6) DBP, mean mmHg (SD) Control arm: pre 86.0 (11.0), post 83.0 (10.4) Intervention arm: pre 86.0 (12.0), post 83.0 (13.1) 7) LDL, mean mg/dL (SD) Control arm: pre 123.0 (38.0), post 109.0 (36.3) Intervention arm: pre 123.0 (37.0), post 106.0 (31.5) |
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| Funding source | This research was supported by the Office of Research and Development, Health Services Research and Development Service, Department of Veterans Affairs (IIR 970771). This work was also supported in part by the Michigan Diabetes Research and Training Center Grant P60DK20572 from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, Bethesda, Maryland. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
| Patient's baseline outcomes (selection bias) | Low 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) | Unclear risk | Information not available. |
| Other bias | Low risk | Information not available. |