Kim 2009.
Study characteristics | ||
Methods |
A community‐based, culturally tailored behavioral intervention for Korean Americans with type 2 diabetes Patient RCT (0 clusters and NA providers), conducted in Korean Resource Center in Baltimore in USA 2 arms: (control arm) (intervention arm) |
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Participants | Control arm N: 42 Intervention arm N: 41, NA, NA Diabetes type: 2 Mean age: 56.4 ± 8.05 % Male: 55.7 Longest follow‐up: 7 months |
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Interventions |
Control arm: (non‐tailored phone calls) Intervention arm: (tailored phone calls from nurses) 1) Case management 2) Patient education 3) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein |
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Funding source | This research is supported by a grant from the National Institutes of Health (NIDDK R34 DK071957), LifeScan, Inc (HCC002154), and the Johns Hopkins University School of Medicine General Clinical Research Center (M01‐RR00052), from the National Center for Research Resources/National Institutes of Health (NCT00505960) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomly assigned to either the SHIP‐DM intervention group (n = 41) or the control (delayed intervention) group (n = 42) by computer‐automated random assignment. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. P values provided and greater than 0.05. |
Patient's baseline outcomes (selection bias) | High risk | Table 1. P values provided and cholesterol levels were significantly different at baseline. |
Incomplete outcome data (attrition bias) | Low risk | One participant from the intervention group and 3 from the control group withdrew because of a lack of time (retention rate = 95.2%). |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure of HbA1c, LDL, BP. |
Selective reporting (reporting bias) | High risk | Prospectively registered protocol, secondary outcomes between protocol and paper were not consistent. |
Risk of contamination (other bias) | Low risk | Remotely delivered intervention. Control participants did not have access to testing device. |
Other bias | Low risk | None identified. |