Sixta 2008.
| Methods |
Randomised controlled clinical trial (RCT): 2 groups Randomisation ratio: 1:1 Superiority design |
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| Participants |
Inclusion criteria:
Exclusion criteria: no exclusion criteria specifically stated Diagnostic criteria: Participating population: Mexican Americans diagnosed with type 2 diabetes |
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| Interventions |
Number of study centres: 1 Treatment before study: not stated Titration period: n/a Intervention: Intervention was a 10‐week diabetes self‐management course taught by 2 promotoras, who were employed by the clinic and supervised by nurses. 10 weekly group sessions lasted for 90 minutes. A scripted course curriculum was used by the promotoras to maintain consistency and accuracy of information. The course was presented in Spanish and was culturally sensitive. The promotoras were the primary instructors and presented the information in a manner that participants could understand Control: Participants in the control group did not receive the intervention until after the trial was complete (wait‐listed control group) Provider: Intervention was provided by promotoras, employed by the clinic and supervised by nurses |
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| Outcomes | Assessed at baseline, at 3 months and at 6 months Primary outcomes:
Secondary outcome(s): |
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| Study details |
Run‐in period: unclear Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: Ruth L. Kirschstein National Research Service Award 1 F31 Publication status: peer‐reviewed journal |
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| Stated aim of study | Quote from publication: "The purpose of this study is to evaluate the impact of a promotora‐led diabetes self‐management program by comparing the outcomes (knowledge, beliefs and HbA1c level) of Mexican American patients with type 2 diabetes who received usual diabetic care in a wait‐listed control group to those who received self‐management education and follow‐up by promotoras in consultation with clinic providers and staff" | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: method of randomisation not specified |
| Allocation concealment (selection bias) | Unclear risk | Comment: not commented on |
| Blinding of participants and personnel (performance bias) Objective outcomes | High risk | Comment: participants not blinded |
| Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Comment: participants not blinded |
| Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C | Low risk | Quote from publication: "The HbA1c level was drawn by a laboratory technician using a standard venipuncture technique. The samples were sent by the CHC to a consistent, commercial, Clinical Laboratory Improvement Amendments–accredited laboratory. Results were sent back to the CHC via a protected Web site" |
| Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Quote from publication: "Bilingual research assistants, masked to the group assignment, collected information through interviews in the patient's language of choice in a private setting at the clinic" Comment: These results still included self‐reported outcome measures, however from non‐blinded participants |
| Incomplete outcome data (attrition bias) Objective outcomes | Unclear risk | Quote from publication: "No subjects were eliminated because of missing data." Only 50% of participants "completed baseline, 3‐month and 6‐month assessments" Comment: no further information given |
| Incomplete outcome data (attrition bias) Subjective outcomes | Unclear risk | Quote from publication: "No subjects were eliminated because of missing data." Only 50% of participants "completed baseline, 3‐month and 6‐month assessments" No further information given Comment: no further information given |
| Selective reporting (reporting bias) | Unclear risk | Comment: none apparent but study protocol not seen |
| Other bias | Unclear risk | Comment: none |