Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors

This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.

Study Overview

• Status: Completed
• Conditions: Stroke; Hypertension
• Intervention / Treatment: Behavioral: Home BP Telemonitoring (HBPTM); Behavioral: Nurse Case Management (NCM)

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Black or Hispanic
• Age 18 years or older
• English or Spanish speaking
• Patients who have had an ischemic or hemorrhagic stroke
• Modified Rankin scale score of ≤ 3
• Average screening SBP ≥ 140 mm Hg from three BP readings taken at two separate visits with a validated automated device
• Receiving care at the study site for at least 6 months and planning to continue receiving care at the site for the next two years.

Exclusion Criteria:

• Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the HBPTM or interacting with the NCM if he/she were to be randomized to the intervention group)
• Participation in other clinical trials
• Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record)
• Patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large BP cuff
• Diagnosis of dialysis or end stage renal disease
• Relocating out of area or extended travel during study period
• Significant verbal speech impairment; unable to participate in intervention telephone sessions
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Home BP Telemonitoring (HBPTM); Participants will take home BP readings 3 days per week (morning and evening) for one week out of each month during the 12-month intervention.	Behavioral: Home BP Telemonitoring (HBPTM); Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.
Experimental: HBPTM + Nurse Case Management (NCM); Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention.	Behavioral: Home BP Telemonitoring (HBPTM); Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.; Behavioral: Nurse Case Management (NCM); Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
12-month systolic blood pressure (SBP) change	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
24-month stroke recurrence	24 months
Cost-effectiveness for reducing SBP at 12 months	12 months
Cost-effectiveness for reducing stroke recurrence at 24 months	24 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in other stroke risk factors	lipids, blood glucose	6, 12, 24 months
Change in health behaviors	diet, physical activity, medication adherence, weight loss	6, 12, 24 months
Antihypertensive medication intensification	adding, changing dose, or changing class of medications	6, 12, 24 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)

Publications and helpful links

General Publications

• Spruill TM, Williams O, Teresi JA, Lehrer S, Pezzin L, Waddy SP, Lazar RM, Williams SK, Jean-Louis G, Ravenell J, Penesetti S, Favate A, Flores J, Henry KA, Kleiman A, Levine SR, Sinert R, Smith TY, Stern M, Valsamis H, Ogedegbe G. Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial. Trials. 2015 Mar 15;16:97. doi: 10.1186/s13063-015-0605-5.

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2014
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 10, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 13, 2013

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 13-00281; U54NS081765-5162 (Other Identifier: National Institute of Neurological Disorders and Stroke (NINDS)); U54NS081765 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No