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

Bonner 2018.

Study characteristics
Methods Care management to promote treatment adherence in patients with cognitive impairment and vascular risk factors: a demonstration project
RCT (NA clusters and NA providers), conducted in 1) Primary care and Memory Disorders Clinic, Veteran's Affairs, Seattle, Washington, USA. 2) Registered Nurse in United States of America
2 arms: 1) Control (usual care) (control arm) and 2) Intervention (care management) (intervention arm)
Participants Control arm N: 17
Intervention arm N: 16, NA, NA
Diabetes type: 2
Mean age: 65.2 ± NR
% Male: 97
Longest follow‐up: 12 months
Interventions Control arm: (usual care)
Intervention arm: (care management)
1) Case management
2) Patient education
Outcomes Glycated haemoglobin
Systolic blood pressure
Diastolic blood pressure
Funding source This work was supported by the U.S. Department of Veterans Affairs, VISN 20, through a Memorandum of Understanding with the VISN 20 Geriatric Research, Education and Clinical Center (GRECC)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were assigned to intervention or usual care group using a pseudo‐randomisation procedure (selecting among 3 sealed envelopes, 1 of which contained a usual care assignment and 2 of which contained an intervention assignment).
Allocation concealment (selection bias) Low risk Participants were assigned to intervention or usual care group using a pseudo‐randomisation procedure (selecting among 3 sealed envelopes, 1 of which contained a usual care assignment and 2 of which contained an intervention assignment).
Patient's baseline characteristics (selection bias) Low risk Table 1, P values provided and above 0.05 except for 1, which is not applicable to us.
Patient's baseline outcomes (selection bias) Low risk Table 1, P values provided and above 0.05 except for 1, which is not applicable to us.
Incomplete outcome data (attrition bias) Low risk One participant (1/17 or 6%) in the usual care group was excluded after randomisation due to determination of no cognitive impairment.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) Low risk Objective measure for HbA1c, BP.
Selective reporting (reporting bias) Unclear risk No registered protocol; methods match outcomes.
Risk of contamination (other bias) Low risk Unlikely that control patients received the care management intervention. The intervention primarily used telephone contact in order to minimise travel for participants, although some participants chose to have in‐person visits with the care manager.
Other bias Low risk No evidence of other risk of bias.