Fortmann 2017.
Study characteristics | ||
Methods |
Dulce Digital: an mHealth SMS‐based intervention improves glycemic control in Hispanics with type 2 diabetes RCT (NA clusters and NA providers), conducted in 1) Remote m‐Health intervention. Participants were recruited from clinic sites within Neighborhood Healthcare, a network of federally qualified health centres in San Diego and Riverside, California counties that serves predominantly low‐income individuals of an ethnic/racial minority. 2) Study co‐ordinator. In United States of America. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (Dulce Digital mHealth) (intervention arm) |
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Participants | Control arm N: 63 Intervention arm N: 63, NA, NA Diabetes type: 2 Mean age: 48.43 ± 2.12 % Male: 25 Longest follow‐up: 6 months |
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Interventions |
Control arm: (usual care) 1) Patient education 2) Financial Incentives Intervention arm: (Dulce Digital mHealth) 1) Case management 2) Patient education 3) Promotion of self‐management 4) Patient reminders 5) Financial incentives |
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Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein |
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Funding source | The current research was supported by McKesson Foundation grant 115M803379 and National Center for Advancing Translational Sciences grant NCATS 1UL1 TR001114‐01. The Investigator‐Initiated Study Program of LifeScan, Inc., provided glucose testing meters and strips for all participants. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blocked random assignment with equal allocation was used to assign participants to Dulce Digital or usual care (UC), using a randomly generated numbers sequence. |
Allocation concealment (selection bias) | Unclear risk | Not reported. Participants were informed of group assignment after the baseline assessment. |
Patient's baseline characteristics (selection bias) | Low risk | Table 1. Almost all characteristics are statistically similar, except oral medication and insulin, which have significant P values. |
Patient's baseline outcomes (selection bias) | Low risk | No between‐group differences were observed in clinical outcomes at baseline (P values 0.10). |
Incomplete outcome data (attrition bias) | High risk | Figure 1. 57/63 (90%) completed both 3‐ and 6‐month follow‐up, 6 dropouts (10%) in control. 47/63 (75%) completed both 3‐ and 6‐month follow‐up, 16 dropouts (25%) in intervention. Quote: "First, although attrition was comparable to that observed in prior studies (35), attrition was higher in the intervention group relative to the UC group. Thus, it is possible that participants who remained in the study were more engaged. A worst‐case scenario sensitivity analysis is presented in Supplement A." |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure of HbA1c, BP, LDL. Outcomes objectively measured (extracted from electronic health records, determined using laboratory tests and standardised protocols). |
Selective reporting (reporting bias) | High risk | Prospectively registered protocol. Only HbA1c was listed as an outcome in the protocol; paper had many more outcomes. Table 2 shows that data were only collected for a subset for several outcomes. |
Risk of contamination (other bias) | Low risk | Patient randomised, however mHealth remotely ran intervention. Unlikely that the intervention received Dulce Digital. |
Other bias | Low risk | None identified. |