Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
Completed · Not applicable
Conditions studied: Stroke, Hypertension
In brief
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.
Key facts
- Study ID
- NCT02011685
- Run by
- NYU Langone Health
- People needed
- 450
- Starts
- 2014-04-18
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2022-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- NYU School of Medicine — New York, New York, United States
Full record on ClinicalTrials.gov
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