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

This study is currently recruiting participants.
Verified November 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02011685
First Posted: December 13, 2013
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
New York University School of Medicine
December 10, 2013
December 13, 2013
November 22, 2017
December 2013
February 2018   (Final data collection date for primary outcome measure)
  • 12-month systolic blood pressure (SBP) change [ Time Frame: Baseline, 12 months ]
  • 24-month stroke recurrence [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT02011685 on ClinicalTrials.gov Archive Site
  • Cost-effectiveness for reducing SBP at 12 months [ Time Frame: 12 months ]
  • Cost-effectiveness for reducing stroke recurrence at 24 months [ Time Frame: 24 months ]
Same as current
  • Change in other stroke risk factors [ Time Frame: 6, 12, 24 months ]
    lipids, blood glucose
  • Change in health behaviors [ Time Frame: 6, 12, 24 months ]
    diet, physical activity, medication adherence, weight loss
  • Antihypertensive medication intensification [ Time Frame: 6, 12, 24 months ]
    adding, changing dose, or changing class of medications
Same as current
 
Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Stroke
  • Hypertension
  • 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).
  • 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.
    Intervention: Behavioral: Home BP Telemonitoring (HBPTM)
  • 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.
    Interventions:
    • Behavioral: Home BP Telemonitoring (HBPTM)
    • Behavioral: Nurse Case Management (NCM)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
December 2018
February 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Gbenga Ogedegbe, MD 212-263-4183 olugbenga.ogedegbe@nyumc.org
United States
 
 
NCT02011685
13-00281
U54NS081765-5162 ( Other Identifier: National Institute of Neurological Disorders and Stroke (NINDS) )
U54NS081765 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
New York University School of Medicine
New York University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
New York University School of Medicine
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP