Clinical trial NCT02011685: Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
Official title: Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-12-13
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 12-month systolic blood pressure (SBP) change
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: 24-month stroke recurrence
timeFrame: 24 months
measure: Cost-effectiveness for reducing SBP at 12 months
timeFrame: 12 months
measure: Cost-effectiveness for reducing stroke recurrence at 24 months
timeFrame: 24 Months
Other outcomes:
measure: Change in other stroke risk factors
timeFrame: 6, 12, 24 months
measure: Change in health behaviors
timeFrame: 6, 12, 24 months
measure: Antihypertensive medication intensification
timeFrame: 6, 12, 24 months
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
References:
citation: 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.