Hotu 2010.
| Study characteristics | ||
| Methods |
A community‐based model of care improves blood pressure control and delays progression of proteinuria, left ventricular hypertrophy and diastolic dysfunction in Maori and Pacific patients with type 2 diabetes and chronic kidney disease: a randomized controlled trial Patient RCT, conducted in hospital diabetes and renal clinics and primary care practices in 2 areas of Auckland, NZ, which provides comprehensive public health care, New Zealand Two arms: 1. Usual care (control arm) and 2. Community/intervention care (intervention arm) |
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| Participants | Control arm N: 32 Intervention arm N: 33 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 12 months |
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| Interventions |
Control arm: 1) Patient education Intervention arm: 1) Case management 2) Team changes 3) Patient education 4) Financial incentives |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.5 (1.9), post 7.9 (1.7) Intervention arm: pre 8.3 (1.6), post 8.0 (1.9) 2) SBP, mean mmHg (SD) Control arm: pre 161.0 (20.0), post 149.0 (23.0) Intervention arm: pre 161.0 (20.0), post 140.0 (19.0) 3) DBP, mean mmHg (SD) Control arm: pre 85.0 (12.0), post 77.0 (12.0) Intervention arm: pre 88.0 (9.0), post 78.0 (11.0) |
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| Funding source | This work was supported by funding from Auckland District Health Board and grants from the Health Research Council of New Zealand and Eli Lilly | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Does not describe process of randomisation. |
| Allocation concealment (selection bias) | Unclear risk | Does not describe process of allocation concealment. |
| Patient's baseline characteristics (selection bias) | Low risk | Quote: "there were no significant differences in any of the variables between the groups." |
| Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
| Incomplete outcome data (attrition bias) | High risk | Per‐protocol analysis, baseline based on those randomised. They provide the numbers and reasons for loss to follow‐up, but reasons are not entirely clear for the control group. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Primary: BP, using Omron.
Secondary: HbA1c, objective laboratory methods not described. Blinding not described. |
| Selective reporting (reporting bias) | Low risk | Checked protocol and everything matches. |
| Risk of contamination (other bias) | Low risk | Information not available. |
| Other bias | Low risk | Information not available. |