Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/25/2018 |
| Start Date: | December 2013 |
| End Date: | December 2018 |
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.
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.
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
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