Carter 2011.
Study characteristics | ||
Methods |
A patient‐centric, provider‐assisted diabetes telehealth self‐management intervention for urban minorities Patient RCT, conducted with patients recruited from a primary care practice in Washington, DC, intervention was home‐based, USA Two arms: 1) Control (control arm) and 2) Treatment (intervention arm) |
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Participants | Control arm N: 21 Intervention arm N: 26 Diabetes type: type 2 Mean age: NR ± NR % Male: NR Longest follow‐up: 9 months |
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Interventions |
Control arm: None Intervention arm: 1) Case management 2) Facilitated relay of clinical information 3) Patient education 4) Promotion of self‐management |
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Outcomes | 1) HbA1c, mean % (SD) Control arm: pre 8.8 (NR), post 7.9 (NR) Intervention arm: pre 9.0 (NR), post 6.8 (NR) 2) SBP, mean mmHg (SD) Control arm: pre 148.0 (NR), post 140.0 (NR) Intervention arm: pre 146.0 (NR), post 139.0 (NR) 3) DBP, mean mmHg (SD) Control arm: pre 86.0 (NR), post 72.0 (NR) Intervention arm: pre 90.0 (NR), post 75.0 (NR) |
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Funding source | This research was supported by a National Center on Minority Health and Health Disparities (NCMHD) Research to Reduce Ethnic Disparities in ESRD Export Grant, #5P20MD000512 | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "…using a random numbers table". |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Patient's baseline characteristics (selection bias) | Low risk | Information not available. |
Patient's baseline outcomes (selection bias) | Low risk | Information not available. |
Incomplete outcome data (attrition bias) | High risk | Unsure whether 74 recruited were randomised or just considered for eligibility. For the 27 lost to follow‐up reasons not provided. Baseline based on those analysed; ~45% losses. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Unclear risk | Blinding not described. HbA1c and SBP methods not described. |
Selective reporting (reporting bias) | Low risk | < 2005 approach used since no protocol; outcomes match methods. |
Risk of contamination (other bias) | Low risk | Information not available. |
Other bias | Low risk | No evidence of other bias. |