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

Primary Purpose

Stroke, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home BP Telemonitoring (HBPTM)
Nurse Case Management (NCM)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Home BP Telemonitoring (HBPTM)

HBPTM + Nurse Case Management (NCM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

12-month systolic blood pressure (SBP) change

Secondary Outcome Measures

24-month stroke recurrence
Cost-effectiveness for reducing SBP at 12 months
Cost-effectiveness for reducing stroke recurrence at 24 months

Full Information

First Posted
December 10, 2013
Last Updated
February 17, 2022
Sponsor
NYU Langone Health
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT02011685
Brief Title
Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
Official Title
Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 18, 2014 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home BP Telemonitoring (HBPTM)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HBPTM + Nurse Case Management (NCM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home BP Telemonitoring (HBPTM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nurse Case Management (NCM)
Intervention Description
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).
Primary Outcome Measure Information:
Title
12-month systolic blood pressure (SBP) change
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
24-month stroke recurrence
Time Frame
24 months
Title
Cost-effectiveness for reducing SBP at 12 months
Time Frame
12 months
Title
Cost-effectiveness for reducing stroke recurrence at 24 months
Time Frame
24 Months
Other Pre-specified Outcome Measures:
Title
Change in other stroke risk factors
Description
lipids, blood glucose
Time Frame
6, 12, 24 months
Title
Change in health behaviors
Description
diet, physical activity, medication adherence, weight loss
Time Frame
6, 12, 24 months
Title
Antihypertensive medication intensification
Description
adding, changing dose, or changing class of medications
Time Frame
6, 12, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
NYU School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25873044
Citation
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.
Results Reference
derived

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

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