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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011685
• Other study ID #: 13-00281
• Secondary ID: U54NS081765-5162
• Status: Completed
• Phase: N/A
• Start date: April 18, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Stroke

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.
• 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).

Locations

Country	Name	City	State
United States	NYU School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in other stroke risk factors	lipids, blood glucose	6, 12, 24 months
Other	Change in health behaviors	diet, physical activity, medication adherence, weight loss	6, 12, 24 months
Other	Antihypertensive medication intensification	adding, changing dose, or changing class of medications	6, 12, 24 months
Primary	12-month systolic blood pressure (SBP) change		Baseline, 12 months
Secondary	24-month stroke recurrence		24 months
Secondary	Cost-effectiveness for reducing SBP at 12 months		12 months
Secondary	Cost-effectiveness for reducing stroke recurrence at 24 months		24 Months