Kim 2015.
Study characteristics | ||
Methods |
The effect of a community‐based self‐help intervention: Korean Americans with type 2 diabetes RCT (NA clusters and NA providers), conducted in 1) Naturally occurring community setting. Most research activities took place at a community site, the Korean Resource Center (KRC). 2) The intervention involved a team of bilingual registered nurses and community health workers (CHWs). In United States of America. 2 arms: 1. Control (wait‐list) (control arm) and 2. Intervention (SHIP‐DM: education, counselling and behavioural coaching) (intervention arm) |
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Participants | Control arm N: 130 Intervention arm N: 120, NA, NA Diabetes type: 2 Mean age: 58.7 ± 8.38 % Male: 56.9 Longest follow‐up: 12 months |
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Interventions |
Control arm: (wait‐list) 1) Patient education Intervention arm: (SHIP‐DM: education, counselling and behavioural coaching) 1) Case management 2) Team change 3) Patient education 4) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Hypertension control |
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Funding source | The study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (R18 DK083936), with material support from LifeScan, including devices (OneTouch glucometer, OneTouch UltraSoft test strips, and OneTouch UltraSoft lancets) for study participants. In addition, the Johns Hopkins Institute for Clinical and Translational Research supported the cost of blood serum lab tests. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported in text and protocol. |
Allocation concealment (selection bias) | Unclear risk | Not reported in text and protocol |
Patient's baseline characteristics (selection bias) | Low risk | Table 1, P values higher than 0.05 for all characteristics. |
Patient's baseline outcomes (selection bias) | High risk | P < 0.05 for LDL and diastolic blood pressure at baseline. More hypertensive patients in control group (P < 0.05) at baseline. |
Incomplete outcome data (attrition bias) | High risk | Total of 41 out of 250 lost to follow‐up (16.4%). More lost to follow‐up in control group (20.0% vs 12.5% in intervention group). The wait‐list control group was oversampled for its lower retention rate. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Our outcomes of interest are all objective (HbA1c, SBP, DBP, controlled BP and LDL). |
Selective reporting (reporting bias) | Low risk | Prospectively registered protocol (protocol first posted in December 2010, study done between September 2010 and December 2014, 1‐year intervention). Results match protocol. |
Risk of contamination (other bias) | Low risk | Only patients in the intervention group received education session and calls from case managers. The case managers never called the control group. |
Other bias | Low risk | No evidence of other bias. |