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

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)
Participants Control arm N: 21
Intervention arm N: 26
Diabetes type: type 2
Mean age: NR ± NR
% Male: NR
Longest follow‐up: 9 months
Interventions Control arm:
None
Intervention arm:
1) Case management
2) Facilitated relay of clinical information
3) Patient education
4) Promotion of self‐management
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)
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.