Rothschild 2013.

Methods	Parallel randomised controlled clinical trial (RCT) Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: Patient born in Mexico or ≥ 1 parent or ≥ 2 grandparents born in Mexico Age ≥ 18 years Diagnosis of type 2 diabetes Taking ≥ 1 oral hypoglycaemic agent “To have health insurance or receive primary care through a free clinic or public facility at time of enrolment” Exclusion criteria: “active treatment of schizophrenia” “inability to provide informed consent” “previous major end‐organ complications of diabetes such as end‐stage renal disease or stroke” Another household member in this study Patients planning extended travel in the next 12 months Diagnostic criteria: not stated Participating population: 144 Mexican Americans in the Chicago area
Interventions	Number of study centres: not stated Treatment before study: All participants were taking at least 1 oral hypoglycaemic agent. 35.4% were taking aspirin, and 46.5% were taking an ACEi or an ARB. The mean number of medications a patient was taking at baseline was 4.8 (SD = 2.9) The intervention included 36 visits over 2 years from a community health worker (from the same community), who delivered behavioural self‐management training using a curriculum derived from recommendations of the American Academy of Diabetes Educators (the AADE 7)
Outcomes	Primary outcomes: Serum HbA1c level Controlled vs uncontrolled blood pressure (controlled defined as < 130/80) Secondary outcomes: Medication adherence Glucose self‐monitoring Self‐management behaviours (measured by the Summary of Diabetes Self‐Care Activities measure) Self‐efficacy (measured via the Diabetes Empowerment Scale: higher = greater self‐efficacy)
Study details	Run‐in period: recruitment of participants took place between January 2006 and September 2008 Study terminated before regular end: no
Publication details	Language of publication: English Funding: National Institute for Diabetes and Digestive and Kidney Diseases Publication status: peer‐reviewed journal
Stated aim of study	To assess whether community health workers can improve glycaemic control among Mexican Americans with diabetes
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "Randomisation used a permuted block design with block sizes of 4 and 6 in a single randomisation scheme. The Rush Preventive Medicine Data Management Center generated randomisation lists"
Allocation concealment (selection bias)	Unclear risk	Comment: concealment method not described
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: participants and HCWs not blinded, which may artificially alter their performance in diabetic management
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: participants and HCWs not blinded, which may artificially alter their performance in diabetic management
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: Research assistants blinded to participants’ group assignments collected outcome data at 12 and 24 months after randomisation
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: Self‐reported subjective outcome measures are at high risk of bias given that participants were not blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: data not available
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: data not available
Selective reporting (reporting bias)	Unclear risk	Comment: large quantity of baseline data collected, and follow‐up data not adequately provided. For instance, blood pressure is dichotomised as an outcome, whereas it is presented as continuous at baseline. Self‐efficacy is reported as "increasing significantly for both study arms," but no further details are provided
Other bias	Unclear risk	Comment: none