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Randomized Controlled Trial
. 2024 Jul 2;332(1):41-50.
doi: 10.1001/jama.2024.6609.

Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial

Affiliations
Randomized Controlled Trial

Home Blood Pressure Telemonitoring and Nurse Case Management in Black and Hispanic Patients With Stroke: A Randomized Clinical Trial

Gbenga Ogedegbe et al. JAMA. .

Abstract

Importance: Black and Hispanic patients have high rates of recurrent stroke and uncontrolled hypertension in the US. The effectiveness of home blood pressure telemonitoring (HBPTM) and telephonic nurse case management (NCM) among low-income Black and Hispanic patients with stroke is unknown.

Objective: To determine whether NCM plus HBPTM results in greater systolic blood pressure (SBP) reduction at 12 months and lower rate of stroke recurrence at 24 months than HBPTM alone among Black and Hispanic stroke survivors with uncontrolled hypertension.

Design, setting, and participants: Practice-based, multicenter, randomized clinical trial in 8 stroke centers and ambulatory practices in New York City. Black and Hispanic study participants were enrolled between April 18, 2014, and December 19, 2017, with a final follow-up visit on December 31, 2019.

Interventions: Participants were randomly assigned to receive either HBPTM alone (12 home BP measurements/week for 12 months, with results transmitted to a clinician; n = 226) or NCM plus HBPTM (20 counseling calls over 12 months; n = 224).

Main outcomes and measures: Primary outcomes were change in SBP at 12 months and rate of recurrent stroke at 24 months. Final statistical analyses were completed March 14, 2024.

Results: Among 450 participants who were enrolled and randomized (mean [SD] age, 61.7 [11.0] years; 51% were Black [n = 231]; 44% were women [n = 200]; 31% had ≥3 comorbid conditions [n = 137]; 72% had household income <$25 000/y [n = 234/324]), 358 (80%) completed the trial. Those in the NCM plus HBPTM group had a significantly greater SBP reduction than those in the HBPTM alone group at 12 months (-15.1 mm Hg [95% CI, -17.2 to -13.0] vs -5.8 mm Hg [95% CI, -7.9 to -3.7], respectively; P < .001). The between-group difference in SBP reduction at 12 months, adjusted for primary care physician clustering, was -8.1 mm Hg (95% CI, -11.2 to -5.0; P < .001) at 12 months. The rate of recurrent stroke was similar between both groups at 24 months (4.0% in the NCM plus HBPTM group vs 4.0% in the HBPTM alone group, P > .99).

Conclusions and relevance: Among predominantly low-income Black and Hispanic stroke survivors with uncontrolled hypertension, addition of NCM to HBPTM led to greater SBP reduction than HBPTM alone. Additional studies are needed to understand the long-term clinical outcomes, cost-effectiveness, and generalizability of NCM-enhanced telehealth programs among low-income Black and Hispanic stroke survivors with significant comorbidity.

Trial registration: Clinical Trials.gov Identifier: NCT02011685.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Screening, Randomization, and Flow of Patients Through a Trial of Nurse Case Management and Home Blood Pressure Telemonitoring for Blood Pressure Control
WHO indicates World Health Organization. aRandomization occurred after completion of a baseline interview and was conducted using a SAS macro performed by the data coordinating center. Randomization was performed for individual patients within primary care physicians.
Figure 2.
Figure 2.. Changes in Systolic Blood Pressure (BP) Between Baseline and 12-Month Follow-Up by Treatment Group
The parallel line plot contains 1 vertical line for each participant with the circle representing baseline values and the line indicating increase or decrease in blood pressure. The boxes indicate median (crossbar) and first and third quartiles (box ends) with whiskers representing the furthest point 1.5 IQR distance from first and third quartiles. Lower whiskers represent minimum value if within the 1.5 IQR distance from the first quartile. Dots indicate values greater than 1.5 IQR distance from the first and third quartiles. Triangles indicate values greater than 3 IQR distance from the first and third quartiles.
Figure 3.
Figure 3.. Survival Probability of the Primary Efficacy Outcome of Recurrent Stroke, Stratified by Treatment Group
Recurrent stroke included stroke of ischemic and hemorrhagic nature. The mean (SD) follow-up period for both groups was 10.9 (5.3) months for the nurse case management plus home blood pressure (BP) telemonitoring group and 11.2 (6.1) months for the home blood pressure monitoring alone group. The shaded areas represent 95% Hall-Wellner confidence bands.

References

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