Greenwood 2015.
| Study characteristics | ||
| Methods |
Overcoming clinical inertia: a randomized clinical trial of a telehealth remote monitoring intervention using paired glucose testing in adults with type 2 diabetes RCT (NA clusters and NA providers), conducted in 1) Primary care. The study was conducted in a large healthcare system in California with an established diabetes management program with telephonic nurse care co‐ordination for diabetes population health management. 2) Intervention was delivered by certified diabetes educators (CDEs). In United States of America. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (Telehealth Remote Monitoring) (intervention arm) |
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| Participants | Control arm N: 45 Intervention arm N: 45, NA, NA Diabetes type: 2 Mean age: 58 ± 10.75 % Male: 77 Longest follow‐up: 6 months |
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| Interventions |
Control arm: (usual care) 1) Case management 2) Team change 3) Electronic patient registry 4) Patient education 5) Promotion of self‐management 6) Patient reminders Intervention arm: (Telehealth Remote Monitoring) 1) Case management 2) Team change 3) Electronic patient registry 4) Patient education 5) Promotion of self‐management 6) Patient reminders |
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| Outcomes | Glycated haemoglobin | |
| Funding source | This research project has research support from the Investigator Initiated Studies program of LifeScan Corporation, IntelGE Care Innovations, Sutter Institute for Medical Research, The Betty Irene Moore School of Nursing, The Jonas Center for Nursing Excellence, and the University of California Davis, National Center for Advancing Translational Sciences, National Institutes of Health, through grant number UL1 TR 000002 | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A permuted block, with blocks of 4 and 6, and a computer‐generated random number table were utilised for randomisation. |
| Allocation concealment (selection bias) | Low risk | After participants signed the consent form, the research co‐ordinator assigned sequential study identification (ID) numbers. The investigator matched the ID numbers to the random number table to assign study group. Participants were notified of group assignment by email after completing online baseline self‐assessment questionnaires. |
| Patient's baseline characteristics (selection bias) | Unclear risk | See Table 1. P > 0.06 except more people with a high cholesterol comorbidity (self‐reported hyperlipidaemia) in the intervention arm (n = 36/45, 80%) compared to the control arm (n = 24/45 = 53%), P = 0.006. Unsure if this will bias results. |
| Patient's baseline outcomes (selection bias) | Low risk | Table 1. Means HbA1c are similar between control (8.2±1.1) and intervention (8.5±1.1) at baseline, P above 0.05. |
| Incomplete outcome data (attrition bias) | Low risk | Overall, 9 out of 90 participants were lost to follow‐up (10%). Numbers balanced between groups. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Our outcome of interest is objective (HbA1c). Blinding of participants, providers and the research team was not possible. |
| Selective reporting (reporting bias) | Low risk | Prospectively registered protocol (protocol first posted on October 2012, study was conducted between January and October 2013). All outcomes of interest are reported. |
| Risk of contamination (other bias) | Unclear risk | The same CDEs and nurses managed the care of patients in the intervention and the control arms, possibly contaminating the usual care group. The control arm was exposed to many components of the intervention, but to a lower extent. |
| Other bias | Low risk | No evidence of other bias. |