Crowley 2016.
| Study characteristics | ||
| Methods |
Practical telemedicine for veterans with persistently poor diabetes control: a randomized pilot trial RCT (NA clusters and NA providers), conducted in 1) Partnered with Durham Veterans Health Administration (VHA) Home Telehealth (HT) programme nurses to create Advanced Comprehensive Diabetes Care (ACDC). VHA has implemented HT programmes nationwide, for which all veterans with poor diabetes control qualify. 2) Existing VHA clinical staff delivered the intervention. Used 2 HT nurses (A.T.M. or S.K.) and a single physician (M.J.C.) for intervention implementation. If veterans endorsed depressive symptoms, 2 study psychiatrists (J.A.W. or J.Z.) were involved. In United States of America. 2 arms: 1. Control (usual care) (control arm) and 2. Intervention (ACDC: Advanced Comprehensive Diabetes Care) (intervention arm) |
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| Participants | Control arm N: 25 Intervention arm N: 25, NA, NA Diabetes type: 2 Mean age: 60 ± 5.63 % Male: 96 Longest follow‐up: 6 months |
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| Interventions |
Control arm: (usual care) 1) Patient education Intervention arm: (ACDC: Advanced Comprehensive Diabetes Care) 1) Case management 2) Team change 3) Electronic patient registry 4) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management 7) Patient reminders |
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| Outcomes | Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Harms |
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| Funding source | ACDC was supported by grant RRP 12‐458 from the Veterans Affairs Diabetes QUERI. M.J.C. is supported by Career Development Award 13‐261 from the Veterans Affairs Health Services Research and Development. H.B.B. is supported by Research Career Scientist award RCS 08‐027 from the Veterans Affairs Health Service Research and Development. | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Using a computer‐generated, blocked sequence, a research assistant randomised consenting veterans in an unblinded fashion. |
| Allocation concealment (selection bias) | Low risk | Using a computer‐generated, blocked sequence, a research assistant randomised consenting veterans in an unblinded fashion. |
| Patient's baseline characteristics (selection bias) | Low risk | Table 1. Randomisation groups were generally well balanced. More White in ACDC group (52% vs 32% in control group). |
| Patient's baseline outcomes (selection bias) | Low risk | Table 1. Randomisation groups were generally well balanced. |
| Incomplete outcome data (attrition bias) | Low risk | 46 of 50 veterans (n = 23 in each group) completed their 6‐month assessment (Figure 1). Loss of 8% in each group. Low and balanced numbers. |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective measure for HbA1c, BP. Harms self‐report and objective EHR review. |
| Selective reporting (reporting bias) | High risk | Prospectively registered protocol. Addition of BP outcome in paper when comparing to protocol. In addition, authors performed a subgroup analysis of particularly "engaged" vs "non‐engaged" participants to display efficacy of intervention under optimal compliance. |
| Risk of contamination (other bias) | Low risk | Patient RCT but unlikely that control patients used telemedicine system or received calls from Home Telehealth nurses. |
| Other bias | Low risk | None. |