Ishani 2011.
| Study characteristics | ||
| Methods |
Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes Patient RCT, conducted in Minneapolis VA Health Care System (MVAHCS) in Minneapolis, MN, USA Two arms: 1. Usual care (control arm) and 2. Case management (intervention arm) |
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| Participants | Control arm N: 278 Intervention arm N: 278 Diabetes type: unclear/not reported Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre NR (NR), post 9.1 (NR) Intervention arm: pre NR (NR), post 8.6 (NR) 2) SBP, mean mmHg (SD) Control arm: pre NR (NR), post 144.4 (NR) Intervention arm: pre NR (NR), post 133.7 (NR) 3) LDL, mean mg/dL (SD) Control arm: pre NR (NR), post 118.4 (NR) Intervention arm: pre NR (NR), post 107.3 (NR) 4) Controlled hypertension (< 130/80 mmHg), N under control (%) Control arm: pre NR (NR), post 53 (34) Intervention arm: pre NR (NR), post 100 (64) |
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| Funding source | This study was funded by a Veterans Integrated Service Network 23 Grant | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation schedule. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | High risk | Male gender (P = 0.03); congestive heart failure (P < 0.01). |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | Unclear risk | Do not provide flow diagram, only numbers, however they included n = 19 who were wrongly randomised, and only report number who had face‐to face visits. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: used standardised procedures for the 3 outcomes. |
| Selective reporting (reporting bias) | High risk | Primary outcome is the same; secondary outcome in protocol is safety, whereas secondary outcome in manuscript is percentage achieving goal in composite. |
| Risk of contamination (other bias) | High risk | Information not available. |
| Other bias | Low risk | Information not available. |