McMahon 2012.
| Study characteristics | ||
| Methods |
A randomized comparison of online‐ and telephone‐based care management with internet training alone in adult patients with poorly controlled type 2 diabetes Patient RCT, conducted in the Department of Veterans Affairs (VA) Boston Healthcare System. Four hospital based clinics or 10 community‐based outpatient clinics. In USA. Three arms: 1. Web training (control arm), 2. Telephone care (intervention arm 1) and 3. Online care (intervention arm 2) |
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| Participants | Control arm N: 50 Intervention arm 1 N: 51 Intervention arm 2 N: 51 Diabetes type: type 2 Mean age: 60.2 ± 10.8 % Male: 94.7 Longest follow‐up: 12 months |
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| Interventions |
Control arm: 1) Patient education 2) Promotion of self‐management Intervention arm 1: 1) Case management 2) Team changes 3) Electronic patient registry 4) Patient education 5) Promotion of self‐management Intervention arm 2: 1) Case management 2) Team changes 3) Electronic patient registry 4) Facilitated relay of clinical information 5) Patient education 6) Promotion of self‐management |
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| Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 10.1 (1.4), post 8.4 (1.7) Intervention arm 1: pre 9.9 (1.2), post 8.5 (1.6) Intervention arm 2: pre 9.6 (1.0), post 8.3 (1.1) 2) SBP, mean mmHg (SD) Control arm: pre 139.8 (19.1), post 136.7 (19.3) Intervention arm 1: pre 139.9 (17.4), post 133.2 (17.1) Intervention arm 2: pre 135.6 (17.4), post 135.2 (19.2) 3) DBP, mean mmHg (SD) Control arm: pre 83.1 (15.8), post 77.3 (11.5) Intervention arm 1: pre 80.8 (13.1), post 74.6 (10.7) Intervention arm 2: pre 75.7 (11.8), post 73.2 (10.7) 4) LDL, mean mg/dL (SD) Control arm: pre 92.5 (32.3), post 86.3 (29.4) Intervention arm 1: pre 91.7 (37.8), post 85.9 (27.1) Intervention arm 2: pre 95.1 (29.4), post 92.4 (27.4) |
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| Funding source | The study was supported by grants from VA Health Services Research and Development (TEL‐02‐100), National Institutes of Health (K24 DK063214) and the Department of the Army Cooperative Agreement (DAMD 17‐98‐2‐8017) | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "…through the use of a random number generator…" |
| Allocation concealment (selection bias) | Unclear risk | Quote: "…and a series of sealed envelopes." Envelopes opaque? |
| Patient's baseline characteristics (selection bias) | Low risk | P values in table are all not significantly different. |
| Patient's baseline outcomes (selection bias) | Unclear risk | No baseline measures of outcome provided. |
| Incomplete outcome data (attrition bias) | High risk | ~18% lost to follow‐up in N1 and ~13% in N2, ~7% in N3. Reasons not provided; the numbers who completed the study (where we were able to calculate percentages) were in the text and not in the flow diagram (since they did an intention‐to‐treat analysis). |
| Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | HbA1c and SBP measurements described, laboratory methods. Blinding of outcome assessor not described. |
| Selective reporting (reporting bias) | Low risk | All endpoints match. |
| Risk of contamination (other bias) | High risk | Same case managers between telephone and internet group, potential contamination. |
| Other bias | Low risk | No evidence of other bias. |