Crowley 2013.
| Study characteristics | ||
| Methods |
The cholesterol, hypertension, and glucose education (CHANGE) study: results from a randomized controlled trial in African Americans with diabetes Patient RCT, conducted in 2 clinics in Durham, NC, USA Two arms: 1. Usual care (control arm) and 2. Nurse intervention (intervention arm) |
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| Participants | Control arm N: 177 Intervention arm N: 182 Diabetes type: type 2 Mean age: NR ± NR % Male: 28.0 Longest follow‐up: 12 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Promotion of self‐management 5) Patient reminders |
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| Outcomes | 1) HbA1c, mean % (SE) Control arm: pre 8.0 (0.1), post 7.9 (0.1) Intervention arm: pre 8.0 (0.1), post 7.8 (0.1) 2) SBP, mean mmHg (SE) Control arm: pre 138.8 (0.9), post 134.7 (1.4) Intervention arm: pre 136.8 (0.9), post 137.6 (1.3) 3) LDL, mean mg/dL (SE) Control arm: pre 99.1 (2.2), post 95.5 (2.8) Intervention arm: pre 99.1 (2.2), post 96.5 (2.8) |
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| Funding source | This research was supported by grants from the Robert Wood Johnson Foundation Disparities Research for Change program and the Kate B. Reynolds Foundation | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated block‐randomisation sequence. |
| Allocation concealment (selection bias) | Low risk | Sealed randomisation assignments in sequentially numbered, opaque, identical envelopes. |
| Patient's baseline characteristics (selection bias) | Unclear risk | They state notable for inadequate literacy and annual income, but do not provide data in table. |
| Patient's baseline outcomes (selection bias) | Unclear risk | Not reported. |
| Incomplete outcome data (attrition bias) | High risk | ~3% lost to follow‐up in control group; ~6% lost to follow‐up in intervention group, but reasons for losses to follow‐up not reported. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary outcomes: HbA1c, SBP, LDL, objective laboratory methods not described. |
| Selective reporting (reporting bias) | Low risk | Outcome matches protocol. |
| Risk of contamination (other bias) | High risk | n = 3 in control group mistakenly received the intervention, but analysed in control arm. |
| Other bias | Low risk | Information not available. |