Grilo 2015.
Study characteristics | ||
Methods |
Food insecurity and effectiveness of behavioral interventions to reduce blood pressure, New York City, 2012‐2013 RCT (NA clusters and NA providers), conducted in 1) Patients were recruited from the Ambulatory Care Clinic at Bellevue Hospital in New York City via flyers, face‐to‐face recruitment and physician referral. Intervention delivered at home (telemonitoring). 2) The combined intervention supplements the home blood pressure telemonitoring protocol with patient self‐management support from a nurse case manager. In United States of America. 2 arms: 1. Control (HBPTM: home BP telemonitoring) (control arm) and 2. Intervention (NCM + HBPTM: home BP telemonitoring plus nurse case management) (intervention arm) |
|
Participants | Control arm N: NR Intervention arm N: NR, NA, NA Diabetes type: 2 Mean age: 60.7 ± 55.7 to 73.6 % Male: 42.9 Longest follow‐up: 6 months |
|
Interventions |
Control arm: (HBPTM: home BP telemonitoring) 1) Electronic patient registry 2) Clinician reminder 3) Facilitated relay of clinical information 4) Patient education 5) Promotion of self‐management Intervention arm: (NCM + HBPTM: home BP telemonitoring plus nurse case management) 1) Case management 2) Team change 3) Electronic patient registry 4) Clinician reminder 5) Facilitated relay of clinical information 6) Patient education Promotion of self‐management 7) Patient reminders |
|
Outcomes | Systolic blood pressure | |
Funding source | Funding for this study was provided by K24HL111315 (Ogedegbe) | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported. Participants were randomly assigned to either 1) home BP telemonitoring (HBPTM) alone; or 2) home BP telemonitoring plus nurse case management (HBPTM+NCM). |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Patient's baseline characteristics (selection bias) | Unclear risk | No patient characteristics reported for each arm at baseline. They only report pooled data from both arms (Table 1). |
Patient's baseline outcomes (selection bias) | Unclear risk | No patient characteristics reported for each arm at baseline. They only report pooled data from both arms (Table 1). |
Incomplete outcome data (attrition bias) | High risk | Of the 28 enrolled participants, 23 (82%) completed the 6‐month visit (18% lost). The primary reasons for dropout were family or housing issues and leaving the area. Numbers of lost and reasons for each arm are not reported. |
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias) | Low risk | Objective outcome (SBP). |
Selective reporting (reporting bias) | Unclear risk | No registered or published protocol. Patients were instructed to take BP readings, but they only report SBP and not DBP. However, the primary outcome was 6‐month change in systolic blood pressure (SBP). |
Risk of contamination (other bias) | Unclear risk | Only the intervention group was managed by nurses. However, nurses could communicate with patients' physicians, so this may have changed their behaviour with the control patients they are following. |
Other bias | High risk | No evidence of other bias |