Varney 2014.
Study characteristics | ||
Methods |
Effect of hospital‐based telephone coaching on glycaemic control and adherence to management guidelines in type 2 diabetes, a randomised controlled trial RCT (NA clusters and NA providers), conducted in 1) Diabetes Clinic of St Vincent’s Hospital Melbourne 2) telephone coaching, delivered by a dietitian in Australia 2 arms: 1. Control: (usual care) (control arm) and 2. Intervention: (telephone coaching) (intervention arm) |
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Participants | Control arm N: 47 Intervention arm N: 47, NA, NA Diabetes type: 2 Mean age: 61.5 ± 11 % Male: 68 Longest follow‐up: 12 months |
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Interventions |
Control arm: (usual care) Intervention arm: (telephone coaching) 1) Case management 2) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein |
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Funding source | "The publication of these results would not be possible without the generous financial support of the St Vincent’s Hospital, Research Endowment Fund." | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated block randomisation was undertaken to obtain a one‐to‐one balanced design. |
Allocation concealment (selection bias) | Unclear risk | Allocation blinding was maintained until randomisation, after which participants and the principal researcher were informed of randomisation outcome. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1, P values provided. Age and ethnicity < 0.05, all others balanced. |
Patient's baseline outcomes (selection bias) | Low risk | Table 1, P values provided and greater than 0.05. |
Incomplete outcome data (attrition bias) | High risk | 11 lost in control group (24%), 12 lost in intervention (26%). |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure for HbA1c, BP and LDL. |
Selective reporting (reporting bias) | High risk | Protocol prospectively registered. Results for smoking cessation not reported at 6 or 12 months. Outcomes only provided for 12‐month follow‐up, protocol states 18‐month follow‐up. |
Risk of contamination (other bias) | High risk | Being unblinded, it is also possible that knowledge of group assignment influenced outcomes through favourable expectations associated with randomisation to the intervention group. |
Other bias | Low risk | None. |