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OpenTrials
Completed

NCT Number: NCT02011685

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypertension Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home BP Telemonitoring (HBPTM)

Behavioral

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)

Behavioral

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 outcomes

  1. 12-month systolic blood pressure (SBP) change

    Time frame: Baseline, 12 months

Secondary outcomes

  1. 24-month stroke recurrence

    Time frame: 24 months

  2. Cost-effectiveness for reducing SBP at 12 months

    Time frame: 12 months

  3. Cost-effectiveness for reducing stroke recurrence at 24 months

    Time frame: 24 Months

Other outcomes

  1. Change in other stroke risk factors

    Time frame: 6, 12, 24 months

    lipids, blood glucose

  2. Change in health behaviors

    Time frame: 6, 12, 24 months

    diet, physical activity, medication adherence, weight loss

  3. Antihypertensive medication intensification

    Time frame: 6, 12, 24 months

    adding, changing dose, or changing class of medications

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Dec 13, 2013
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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