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. 2023 May 31;2023(5):CD014513. doi: 10.1002/14651858.CD014513

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)
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
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
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
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.