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

Not Applicable

Completed

• Conditions: Hypertension; Stroke
• Interventions: Behavioral: Home BP Telemonitoring (HBPTM); Behavioral: Nurse Case Management (NCM)

• Registration Number: NCT02011685
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Study Start: 2014-04-18
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBPTM + Nurse Case Management (NCM)	Home BP Telemonitoring (HBPTM)	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.
Home BP Telemonitoring (HBPTM)	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.
HBPTM + Nurse Case Management (NCM)	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.

Primary Outcome Measures

Name	Time	Method
12-month systolic blood pressure (SBP) change	Baseline, 12 months

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness for reducing SBP at 12 months	12 months
24-month stroke recurrence	24 months
Cost-effectiveness for reducing stroke recurrence at 24 months	24 Months

Trial Locations

Locations (1)

NYU School of Medicine; 🇺🇸 New York, New York, United States