Sperl‐Hillen 2013.
| Study characteristics | ||
| Methods |
Are benefits from diabetes self‐management education sustained? RCT (NA clusters and NA providers), conducted in 1) ABQ Health Partners in Albuquerque, New Mexico and HP Clinics in Minneapolis, Minnesota. 2) individual sessions and group sessions delivered by either nurse or dietitian certified diabetes educators. In United States of America. 3 arms: 1. Control: usual care (control arm) and 2. Group intervention (intervention arm), 3. Individual intervention (other arm) |
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| Participants | Control arm N: 134 Intervention arm N: 243, 246, NA Diabetes type: 2 Mean age: 62 ± 10.2 % Male: 51 Longest follow‐up: 12 months |
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| Interventions |
Control arm: (usual care) Intervention arm: (group) 1) Team change 2) Patient education 3) Promotion of self‐management Intervention arm: (individual) 1) Case management 2) Team change 3) Patient education 4) Promotion of self‐management |
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| Outcomes | Glycated haemoglobin | |
| Funding source | This study was funded by Merck Sharp and Dohme Corp. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Consented participants were randomly assigned to GE, IE or UC using a random allocation sequence in a 2:2:1 ratio. |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Unclear risk | Not reported. |
| Patient's baseline outcomes (selection bias) | Low risk | Looks balanced. |
| Incomplete outcome data (attrition bias) | Low risk | The number of patients lost to long‐term follow‐up in each group is about 6% to 7%, and the reasons are explained. 1 dropout, 8 deaths total. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure for HbA1c. |
| Selective reporting (reporting bias) | Low risk | Prospectively registered protocol. They discuss some of the outcomes in other papers. |
| Risk of contamination (other bias) | Unclear risk | Same educators in IE and GE groups. |
| Other bias | Low risk | No evidence of other bias. |