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

Egede 2017.

Study characteristics
Methods Randomized controlled trial of technology‐assisted case management in low income adults with type 2 diabetes
RCT (NA clusters and NA providers), conducted in 1) The participants were recruited from 8 community‐based adult medicine primary care practices within the Franklin C. Fetter Family Health Centers, Inc., South Carolina, USA ‐downtown Charleston, Summerville Health Center, Low Country Pediatrics and Adults, Enterprise Health Center, Cross Health Center, Hollywood, Walterboro, and John’s Island. 2) Intervention delivered by a full‐time registered nurse using the FORA 2‐in‐1 telehealth system for Technology assisted Case Management (TACM). The nurse case manager was supervised by an internist and an endocrinologist. In United States of America.
2 arms: 1. Control (usual care) (control arm) and 2. Intervention (TACM: technology‐assisted case management) (intervention arm)
Participants Control arm N: 59
Intervention arm N: 54, NA, NA
Diabetes type: 2
Mean age: 54.2 ± 10.34
% Male: 18.6
Longest follow‐up: 6 months
Interventions Control arm: (usual care)
Intervention arm: (TACM: technology‐assisted case management)
1) Case management
2) Team change
3) Electronic patient registry
4) Promotion of self‐management
5) Patient reminders
Outcomes Glycated haemoglobin
Funding source This work was supported by Grant No. W81XWH‐10‐2‐0057 from the Department of Defense
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The nurse case manager verified inclusion and exclusion criteria for all participants before randomisation (1:1) to one of the 2 study groups. The randomisation was performed in waves such that about 50 participants were randomised every 6 months. The randomisation sequence was web‐based computer‐generated and was accessible to the nurse case manager, but remained confidential to all study sites.
Allocation concealment (selection bias) Low risk The randomisation sequence was web‐based computer‐generated and was accessible to the nurse case manager, but remained confidential to all study sites.
Patient's baseline characteristics (selection bias) Low risk Table 1. All P values above 0.05. Quote: "There were no significant differences between groups in demographic characteristics."
Patient's baseline outcomes (selection bias) Low risk Table 1. All outcomes reported have P values above 0.05 including HbA1c, BMI and smoking.
Incomplete outcome data (attrition bias) High risk There were 113 patients at baseline, 87 (23% lost) at 3 months and 85 (25% lost) at 6 months that had complete HbA1c measurements. Among the 85 participants that had complete HbA1c measurements at 6 months, 41/54 (24% lost) were in TACM and 44/59 (25%) in the usual care group. Balanced but high number of lost.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk HbA1c was objectively measured.
Selective reporting (reporting bias) Low risk Prospectively registered protocol. This article is focused on reporting the results of the primary outcome analyses (HbA1c) as indicated in our protocol article.
Risk of contamination (other bias) Unclear risk Patient‐randomised. It is unlikely that control patients used the FORA system. However, the nurse could have been involved in the care of patients from both groups as clinic nurses were used to follow‐up on any problematic patients. Quote: "We did not control for attention in the intervention group; therefore, it is reasonable to suggest that while diabetes education and skills training were not directly provided to the patients in the control group, support of any kind from the nurse case manager may have influenced behaviors that resulted in improved glycaemic control."
Other bias Low risk No evidence of other bias.