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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Home BP Telemonitoring (HBPTM) Behavioral
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Home BP Telemonitoring (HBPTM)
    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 2: Kind: Experimental
    Label: HBPTM + Nurse Case Management (NCM)
    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.
  • Nurse Case Management (NCM) Behavioral
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: HBPTM + Nurse Case Management (NCM)
    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.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 12-month systolic blood pressure (SBP) change Baseline, 12 months No
Primary 24-month stroke recurrence 24 months No
Secondary Cost-effectiveness for reducing SBP at 12 months 12 months No
Secondary Cost-effectiveness for reducing stroke recurrence at 24 months 24 months No

Sponsors