Heisler 2014.
| Study characteristics | ||
| Methods |
Comparison of community health worker‐led diabetes medication decision‐making support for low‐income Latino and African American adults with diabetes using e‐health tools versus print materials Patient RCT, conducted in a community health centre in Detroit, serving Latino and African American low‐income, USA Two arms: 1. Print materials (control arm) and 2. iDecide (intervention arm) |
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| Participants | Control arm N: 95 Intervention arm N: 93 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 3 months |
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| Interventions |
Control arm: 1) Case management 2) Patient education 3) Promotion of self‐management 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 8.3 (2.2), post 7.9 (1.9) Intervention arm: pre 8.2 (1.9), post 7.8 (1.7) |
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| Funding source | Agency for Healthcare Research and Quality and National Institute of Diabetes and Digestive and Kidney Diseases | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomly assigned by a computer program, through use of a random‐sequence algorithm, into 1 of 2 study groups. |
| Allocation concealment (selection bias) | Low risk | Web‐based (central allocation). |
| Patient's baseline characteristics (selection bias) | High risk | Education (P < 0.001), difficulty with written info (P = 0.03), confident completing forms (P = 0.003). |
| Patient's baseline outcomes (selection bias) | Low risk | Secondary outcome: HbA1c (P = 0.58). |
| Incomplete outcome data (attrition bias) | Low risk | ~6% lost in both arms, reasons provided and seem balanced. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Secondary outcome: HbA1c, used objective laboratory methods, measured using Bayer DCA2000+ point of care analyser. |
| Selective reporting (reporting bias) | Low risk | Matches protocol. |
| Risk of contamination (other bias) | High risk | Same community centre, with community health workers (CHWs) providing intervention and control, possible contamination? |
| Other bias | Low risk | Information not available. |