Rosal 2005.
Study characteristics | ||
Methods |
Diabetes self‐management among low‐income Spanish‐speaking patients: a pilot study RCT (NA clusters and NA providers), conducted in 1) The intervention was delivered in a community room well known to community residents and located approximately three blocks from the community health centre (CHC) and two blocks from the elder programme, both located in a large metropolitan area in western Massachusetts. 2) Intervention was delivered by a diabetes nurse, a nutritionist and an assistant (all bilingual). In United States of America. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (self‐management group sessions) (intervention arm) |
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Participants | Control arm N: 10 Intervention arm N: 15, NA, NA Diabetes type: 2 Mean age: 62.6 ± NR % Male: 20 Longest follow‐up: 6 months |
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Interventions |
Control arm: (usual care) 1) Facilitated relay of clinical information 2) Patient education Intervention arm: (self‐management group sessions) 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management 5) Continuous quality improvement |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein |
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Funding source | This project was supported by an American Diabetes Association Innovation Award supported in part by Novo Nordisk Pharmaceuticals | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. Participants were grouped as closely as possible by age, gender and insulin status (whether or not they used insulin), and randomised to intervention or control in a 3:2 ratio. |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Low risk | Table 2. Data look similar. |
Patient's baseline outcomes (selection bias) | High risk | Table 3. There is a big difference for HbA1c between control and intervention at baseline (9.3% vs 7.7%, respectively). No P values. |
Incomplete outcome data (attrition bias) | High risk | They lost 2 patients out of 25 randomised (8%). 0 out of 15 patients in the intervention group (0%) and 2 out of 10 in the control group (20%). Unbalanced numbers. Completion rates for baseline, 3‐month and 6‐month assessments were 100%, 92% (23/25) and 92% (23/25), respectively. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Our outcomes of interest were objectively measured (HbA1c, SBP, DBP and LDL). |
Selective reporting (reporting bias) | Unclear risk | No registered or published protocol. Results match methods. |
Risk of contamination (other bias) | Unclear risk | Both groups received an education booklet, and copies of laboratory results following each assessment time point were sent to primary care providers for both groups. |
Other bias | Low risk | None. |