Hawkins 2010.
| Study characteristics | ||
| Methods |
Improving glycemic control in older adults using a videophone motivational diabetes self‐management intervention Patient RCT, conducted with patients recruited by referral from 3 primary care providers within the same clinical practice, USA Two arms: 1. Control (control arm) and 2. Experimental (intervention arm) |
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| Participants | Control arm N: 36 Intervention arm N: 40 Diabetes type: unclear/not reported Mean age: 64.9 ± NR % Male: NR Longest follow‐up: 6 months |
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| Interventions |
Control arm: None Intervention arm: 1) Case management 2) Patient education 3) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.9 (3.1), post 8.3 (NR) Intervention arm: pre 9.0 (2.3), post 7.3 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 160.2 (28.7), post 159.2 (NR) Intervention arm: pre 154.4 (30.4), post 154.0 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 82.3 (12.2), post 81.2 (NR) Intervention arm: pre 79.5 (10.2), post 78.9 (NR) 4) LDL, mean mg/dL (SD) Control arm: pre 128.8 (20.7), post 123.9 (NR) Intervention arm: pre 112.2 (24.8), post 105.2 (NR) |
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| Funding source | Not reported | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomized…using a computer‐generated randomized list." |
| Allocation concealment (selection bias) | Unclear risk | Do not describe allocation concealment. They say that patients and nurses were blinded to allocation until after receiving intervention packets but that does not mean that those who were in charge of randomising the groups were blinded. |
| Patient's baseline characteristics (selection bias) | Low risk | Table and text. Quote: "There were no statistically significant differences between the groups in baseline characteristics." |
| Patient's baseline outcomes (selection bias) | Low risk | HbA1c (P = 0.76); LDL (P = 0.79); DBP (P = 0.45); SBP (P = 0.68). |
| Incomplete outcome data (attrition bias) | Low risk | Per‐protocol analysis completed, baseline based on those analysed, however numbers and reasons for loss to follow‐up provided, and they seem reasonably balanced. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | HbA1c: standard laboratory method. Blood pressure using oscillometric technology. LDL measured using blood analyser. Blinding not well described. We do not know if outcome assessors were blinded. They note that investigators were not blinded to outcome measurements, but we also do not know whether they knew the assignment of patients. |
| Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; methods match results. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |