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

Ratanawongsa 2014.

Study characteristics
Methods Diabetes health information technology innovation to improve quality of life for health plan members in urban safety net
Cross‐over RCT (NA clusters and NA providers), conducted in 1) Telephone call‐based intervention to member of the SFHP in San Francisco, California, USA. 2) “Out‐of‐range” responses triggered callbacks within 3 days from a language‐concordant SFHP lay health coaches. Health coaches – supervised by an SFHP registered nurse care manager – documented in the SFHP care management database system. In United States of America.
2 arms: 1. Control: wait‐list (control arm) and 2. Intervention: automated telephone self‐management support (ATSM)/health coaching (intervention arm)
Participants Control arm N: 180
Intervention arm N: 182, NA, NA
Diabetes type: 3
Mean age: 55.76 ± 9.8
% Male: 25.78
Longest follow‐up: 6.21 months
Interventions Control arm: (wait‐list)
Intervention arm: (automated telephone self‐management support (ATSM)/health coaching)
1) Facilitated relay of clinical information
2) Patient education
3) Promotion of self‐management
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Low‐density lipoprotein
Funding source Disease Control and Prevention grant 5U58DP002007‐03; Health Delivery Systems Center for Diabetes Translational Research (CDTR) funded through NIDDK grant 1P30‐ DK092924; National Institute on Minority Health and Health Disparities #P60MD006902; and the McKesson Foundation. NIH grant UL1 RR024131 supports the UCSF Collaborative Research Network. No funders had any role in the study design; collection, analysis, and interpretation of data; writing of the manuscript; or decision to submit the manuscript for publication.
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported.
Allocation concealment (selection bias) Unclear risk Not reported.
Patient's baseline characteristics (selection bias) Low risk Table 1. All P values greater than 0.05.
Patient's baseline outcomes (selection bias) Low risk Table 1. All P values greater than 0.05.
Incomplete outcome data (attrition bias) High risk Loss of 30%. Loss of 55 in wait‐list group, loss of 55 in intervention.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective HbA1c, BP, LDL measure.
Selective reporting (reporting bias) Low risk Prospectively registered protocol. No mention of LDL measurement in protocol.
Risk of contamination (other bias) Low risk Wait‐list cross‐over RCT.
Other bias Low risk None.