Blackberry 2013.
| Study characteristics | ||
| Methods |
Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial Cluster RCT (59 clusters), conducted in general practices in Victoria, Australia Two arms: 1) Control group (control arm) and 2) Intervention group (intervention arm) |
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| Participants | Control arm N: 237 Intervention arm N: 236 Diabetes type: type 2 Mean age: 62.8 ± 10.5 % Male: 57.0 Longest follow‐up: 18 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Team changes 3) Clinician education 4) Patient education 5) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.1 (1.3), post 7.9 (1.4) Intervention arm: pre 8.0 (1.2), post 7.9 (1.2) 2) SBP, mean mmHg (SD) Control arm: pre 138.0 (18.0), post 136.0 (16.0) Intervention arm: pre 139.0 (18.0), post 133.0 (14.0) 3) DBP, mean mmHg (SD) Control arm: pre 79.0 (11.0), post 77.0 (11.0) Intervention arm: pre 79.0 (10.0), post 76.0 (9.0) 4) LDL, mean mg/dL (SD) Control arm: pre 92.8 (32.9), post 87.4 (32.5) Intervention arm: pre 92.8 (34.4), post 85.9 (33.6) 5) Smoking cessation, N smokers (%) Control arm: pre 27 (11), post 23 (12) Intervention arm: pre 30 (13), post 25 (13) |
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| Funding source | This study was supported by the Australian National Health and Medical Research Council (ID 359374 and 566586). The funder was not involved in the study design, data collection, analysis and interpretation. | |
| 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) | Low risk | Not reported, but since cluster then low risk. |
| Provider's baseline characteristics (selection bias) | Low risk | In text but not in tables. |
| Patient's baseline characteristics (selection bias) | Low risk | In text but not in tables. |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | Low risk | ~5% lost to follow‐up in both arms; reasons provided are similar. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary outcome: HbA1c; laboratories used HbA1c assay methods aligned with standards. Quality assurance HbA1c assays. Secondary outcomes: objective methods not described, but assessors were blinded. |
| Selective reporting (reporting bias) | Low risk | Outcomes matches protocol. |
| Risk of contamination (other bias) | Low risk | Cluster design minimised risk of contamination in control group. |
| Other bias | Low risk | Information not available. |