Trento 2008.
Study characteristics | ||
Methods |
A randomised controlled clinical trial of nurse‐, dietitian‐ and pedagogist‐led group care for the management of Type 2 diabetes Patient RCT, conducted in Italy Two arms: 1. Controls (control arm) and 2. Group care (intervention arm) |
|
Participants | Control arm N: 24 Intervention arm N: 25 Diabetes type: type 2 Mean age: 66.3 ± 8.2 % Male: 59.2 Longest follow‐up: 24 months |
|
Interventions |
Control arm: 1) Patient education Intervention arm: 1) Team changes 2) Patient education 3) Promotion of self‐management |
|
Outcomes | 1) Antihypertensives (any), N users (%) Control arm: pre 18 (75), post 17 (81) Intervention arm: pre 10 (40), post 10 (42) 2) HbA1c, mean % (SD) Control arm: pre 8.0 (1.1), post 8.4 (1.3) Intervention arm: pre 8.0 (1.3), post 7.6 (0.8) 3) SBP, mean mmHg (SD) Control arm: pre 144.8 (23.6), post 150.0 (30.0) Intervention arm: pre 145.0 (22.7), post 135.0 (23.5) 4) DBP, mean mmHg (SD) Control arm: pre 80.4 (10.7), post 76.0 (11.8) Intervention arm: pre 81.0 (11.5), post 76.0 (9.8) |
|
Funding source | "This article was supported by funds from the University of Turin (fondi 60%)". | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Information not available. |
Allocation concealment (selection bias) | Unclear risk | Information not available. |
Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
Incomplete outcome data (attrition bias) | Low risk | Information not available. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | High risk | Information not available. |
Selective reporting (reporting bias) | Low risk | Information not available. |
Risk of contamination (other bias) | Unclear risk | Information not available. |
Other bias | Low risk | Information not available. |