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

Babamoto 2009.

Study characteristics
Methods Improving diabetes care and health measures among Hispanics using community health workers: results from a randomized controlled trial
RCT (NA clusters and NA providers), conducted in 1) Participants were recruited during routine clinic visits at 3 inner‐city family health centres in Los Angeles. For patients in CHW arm, sessions were conducted in accessible community locations, at the clinic, or in the patient’s home. They also received follow‐up calls. Patients in the case management arm were usually seen in the clinic and also had follow‐up calls. 2) Community health workers (CHW arm) and nurses (case management arm) provided the interventions. In United States of America.
3 arms: 1) Control (standard provider care) (control arm), 2) Intervention 1 (community health workers) (intervention arm) and 3) Intervention 2 (case management by nurses) (other arm)
Participants Control arm N: 54
Intervention arm N: 75, 60, NA
Diabetes type: 2
Mean age: 50 ± 13.66
% Male: 36
Longest follow‐up: 6 months
Interventions Control arm: (standard provider care)
1) Patient education
Intervention arm: (community health workers)
1) Case management
2) Patient education
3) Promotion of self‐management
Intervention arm: (case management by nurses)
1) Case management
2) Team change
3) Patient education
4) Promotion of self‐management
Outcomes 1) Glycated haemoglobin
Funding source Project funding was provided by the Pfizer Foundation and Pfizer Health Solutions Inc.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The final study sample consisted of 318 (or 189?) patients randomly assigned to the 3 study arms via a random‐number table.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) High risk There were no significant differences across study groups with respect to age, education and household income; however, when compared with the other groups, the standard provider care group had a greater proportion of females, and the case management group had a greater proportion of patients whose parents had diabetes.
Patient's baseline outcomes (selection bias) Low risk Baseline clinical indicators and self‐reported health measures indicated a population characterised by poor dietary and exercise habits, as well as poor medication‐taking behaviour, with no significant differences at baseline across study groups (Table 2).
Incomplete outcome data (attrition bias) High risk Loss to follow‐up was greatest in the standard provider care group. Significantly greater proportions of patients enrolled in the standard provider care group (50%) and the case management group (43%) were lost to follow‐up, as compared with the CHW group (28%, P < 0.05). With respect to age and annual income, no significant differences were observed between programme graduates and those who disenrolled.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective outcome (HbA1c).
Selective reporting (reporting bias) Unclear risk No registered protocol or previously published protocol. Data match methods.
Risk of contamination (other bias) Unclear risk The standard provider care group, as well as the other randomised groups, may have received higher levels of care during the study period than what they would have normally received in the absence of the intervention. Before study activities began, clinic providers received information about the study objectives... It is conceivable that awareness of the study among clinic providers may have motivated them to be more diligent about the services they offered to study patients.
Other bias Low risk No evidence of other bias.