Garcia 2015.
| Study characteristics | ||
| Methods |
Home‐based diabetes symptom self‐management education for Mexican Americans with type 2 diabetes RCT (NA clusters and NA providers), conducted in 1) The study was set in urban and rural communities in Central Texas where Hispanics comprise 34% of the population. 2) Participants in the experimental condition received 8 weekly in‐home, interactive, one‐on‐one educational and behaviour modification sessions with a bilingual registered nurse (RN) in United States of America 2 arms: 1. Control (wait‐listed control) group (control arm) and 2. Intervention (symptom‐based diabetes self‐management education (DSME) programme) (intervention arm) |
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| Participants | Control arm N: 37 Intervention arm N: 41, NA, NA Diabetes type: 2 Mean age: 49.6 ± 9.33 % Male: 33.33 Longest follow‐up: 6 months |
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| Interventions |
Control arm: (wait‐listed control) Intervention arm: (symptom‐based diabetes self‐management education (DSME) programme) 1) Case management 2) Team change 3) Patient education 4) Promotion of self‐management 5) Patient reminders |
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| Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein |
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| Funding source | National Institute of Diabetes and Kidney and Digestive Diseases at the National Institutes of Health (R21DK076705) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were randomly assigned to the experimental (symptom‐based diabetes self‐management education (DSME) programme) or the wait‐listed control group (WLC). |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Patient's baseline characteristics (selection bias) | Low risk | Table 2 ‐ all P values greater than 0.05. |
| Patient's baseline outcomes (selection bias) | High risk | Table 2 ‐ fasting blood glucose and HbA1c levels were significantly different between control and experimental group at baseline. |
| Incomplete outcome data (attrition bias) | High risk | Large dropout. 27% loss in control group, 28% loss in experimental group. The authors do not provide reasons for the loss (they just mention what they think might have happened). |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measures for HbA1c, SBP, DBP, LDL. |
| Selective reporting (reporting bias) | Unclear risk | No protocol registered. No discrepancy between methods and outcomes. |
| Risk of contamination (other bias) | Low risk | The participants in the intervention arm were followed by RNs, so contamination seems unlikely. |
| Other bias | Low risk | No evidence of other bias. |