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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

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)
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
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
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
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.