Nishita 2012.
Study characteristics | ||
Methods |
Empowered diabetes management: Life coaching and pharmacist counseling for employed adults with diabetes. Patient RCT, conducted with patients recruited through community means ‐ newspaper, HR departments, health fairs, etc., intervention took place in public places. In USA. Two arms: 1. Control (control arm) and 2. Treatment (intervention arm) |
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Participants | Control arm N: 62 Intervention arm N: 128 Diabetes type: type 1 and type 2 Mean age: 48.5 ± 9.8 % Male: 37.4 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 5) Financial incentives |
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Outcomes | 1) HbA1c, mean % (SE) Control arm: pre 7.7 (0.2), post 7.8 (0.1) Intervention arm: pre 7.8 (0.2), post 7.6 (0.1) |
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Funding source | The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Centers for Medicare and Medicaid Services (Grant No. CFDA No. 93.769). | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes, but opaque? |
Patient's baseline characteristics (selection bias) | Low risk | Reported in text and table. |
Patient's baseline outcomes (selection bias) | Low risk | HbA1c, P = 0.77. |
Incomplete outcome data (attrition bias) | High risk | ~16% lost to follow‐up in control; ~35% in intervention. Balance seems okay since 3:1 ratio, but reasons not provided. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary outcome: HbA1c and others, no objective laboratory methods described. |
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 | No evidence of other bias. |