Welch 2015.
Study characteristics | ||
Methods |
An internet‐based diabetes management platform improves team care and outcomes in an urban Latino population RCT (NA clusters and NA providers), conducted in 1) The study was conducted at 2 affiliated Federally Qualified Health Centers (FQHCs) located in Western Massachusetts in an area where more than 30% of families locally live below the federal poverty line. The clinics are located in a medically underserved and health professional shortage area. The 29 clinic providers serve a predominantly (about 80%) Latino urban poor community including more than 2400 diabetic patients. 2) Intervention delivered by diabetes nurses, diabetes dietitians and providers. In United States of America. 2 arms: 1. Control (in house usual diabetes care) (control arm) and 2. Intervention (diabetes dashboard condition) (intervention arm) |
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Participants | Control arm N: 200 Intervention arm N: 199, NA, NA Diabetes type: 2 Mean age: 55 ± 8,81 % Male: 40 Longest follow‐up: 6 months |
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Interventions |
Control arm: (in house usual diabetes care) 1) Patient education 2) Promotion of self‐management Intervention arm: (diabetes dashboard condition) 1) Case management 2) Team change 3) Electronic patient registry 4) Clinician education 5) Clinician reminder 6) Facilitated relay of clinical information 7) Patient education 8) Promotion of self‐management |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Harms |
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Funding source | This project was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, through grant 5R01‐DK‐084325‐04 | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. "We used a parallel‐group randomised design for this clinical trial. Eligible patients were randomised either to the diabetes dashboard intervention condition (IC) or to an in‐house UDC program delivered without access to the diabetes dashboard." |
Allocation concealment (selection bias) | Unclear risk | Not reported. "We used a parallel‐group randomised design for this clinical trial. Eligible patients were randomised either to the diabetes dashboard intervention condition (IC) or to an in‐house UDC program delivered without access to the diabetes dashboard." |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. P above 0.05 for age, race and gender. |
Patient's baseline outcomes (selection bias) | Low risk | Table 1. BMI is close to being significantly different between control and intervention groups at baseline (P = 0.06). Other variables are similar (P above 0.05). |
Incomplete outcome data (attrition bias) | High risk | 46 lost to follow‐up out of 399 (11.5%): 9.5% in the control group and 13.6% in the intervention group. Reasons not balanced (6 patients refused the second visit in the intervention, and only 2 in the control group). |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Objective outcomes (HbA1c, SBP and DPB), but self‐reported hypoglycaemia symptoms (subjective outcome). Blinding not described. |
Selective reporting (reporting bias) | Unclear risk | Retrospectively registered protocol (first posted in June 2014, patients were recruited from December 2010 to December 2012, 6‐month intervention). In the paper, the authors report data about blood pressure, hypoglycaemia and BMI, which were not planned in the protocol. |
Risk of contamination (other bias) | Low risk | The interventionists were not the same for the control and the intervention groups. Quote: "The IC was delivered by a team of four bicultural, bilingual diabetes educators (two diabetes nurses and two diabetes dietitians)... The UDC condition was delivered by four additional bicultural, bilingual diabetes nurses and diabetes dietitians." However, the providers might have changed their approaches with the control group as the same providers were involved in both arms. |
Other bias | Low risk | None identified. |