Siminerio 2013.
| Study characteristics | ||
| Methods |
Who can provide diabetes self‐management support in primary care? Findings from a randomized controlled trial Patient RCT, conducted in primary care practices affiliated with healthcare networks located in 3 Pennsylvania communities, University of Pittsburgh Medical Center Community Medicine, Federally Qualified Health Centers, and Pennsylvania State University Hershey, USA Four arms: 1. Usual education (control arm), 2. Practice staff (intervention arm 1), 3. Peer (intervention arm 2), and 4. Educator (intervention arm 3) |
|
| Participants | Control arm N: 32 Intervention arm 1 N: 35 Intervention arm 2 N: 36 Intervention arm 3 N: 38 Diabetes type: type 2 Mean age: 60.0 ± NR % Male: 50.0 Longest follow‐up: 6 months |
|
| Interventions |
Control arm: 1) Case management 2) Patient education 3) Promotion of self‐management Intervention arm 1: 1) Case management 2) Patient education 3) Promotion of self‐management Intervention arm 2: 1) Case management 2) Patient education 3) Promotion of self‐management Intervention arm 3: 1) Case management 2) Patient education 3) Promotion of self‐management |
|
| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.7 (1.9), post 8.9 (NR) Intervention arm 1: pre 9.0 (2.1), post 9.1 (NR) Intervention arm 2: pre 8.6 (2.4), post 8.6 (NR) Intervention arm 3: pre 8.3 (1.8), post 8.2 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 133.0 (14.0), post 137.3 (NR) Intervention arm 1: pre 133.0 (14.0), post 136.3 (NR) Intervention arm 2: pre 129.0 (13.4), post 126.9 (NR) Intervention arm 3: pre 133.0 (14.0), post 136.7 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 78.0 (10.0), post 81.2 (NR) Intervention arm 1: pre 75.0 (9.0), post 76.6 (NR) Intervention arm 2: pre 76.0 (8.0), post 75.8 (NR) Intervention arm 3: pre 79.0 (9.0), post 82.0 (NR) 4) LDL, mean mg/dL (SD) Control arm: pre 108.0 (41.0), post 116.0 (NR) Intervention arm 1: pre 97.0 (34.0), post 106.0 (NR) Intervention arm 2: pre 97.0 (34.0), post 111.3 (NR) Intervention arm 3: pre 98.0 (32.0), post 92.9 (NR) |
|
| Funding source | This research study is sponsored by the Air Force Surgeon General’s Office under agreement number FA7014‐10‐2‐0005. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the Air Force Surgeon General’s Office or the US Government. | |
| 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 | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | In text and in table. |
| Patient's baseline outcomes (selection bias) | Low risk | HbA1c (P = 0.44); LDL (P = 0.62); SBP (P = 0.35); DBP (P = 0.69). |
| Incomplete outcome data (attrition bias) | High risk | ~9% lost to follow‐up in control; ~20% in primary care physician (PCP); ~14% in peer; ~24% in Educational. Provide overall reasons for losses, but do not pinpoint per arm and numbers. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Primary outcome: HbA1c, do not describe objective laboratory methods. |
| Selective reporting (reporting bias) | High risk | Do not match protocol. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |