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Center for Stroke Disparities Solution - Community Transitions Intervention

Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01918891
Acronym
CSDS
Enrollment
495
Registered
2013-08-08
Start date
2012-09-30
Completion date
2018-06-30
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Stroke, Transient Ischemic Attack

Keywords

stroke, transient ischemic attack, High blood pressure, Hypertension

Brief summary

The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.

Detailed description

Targeted study participants are Black and Hispanic patients with a history of stroke and a current systolic blood pressure (BP) above JNC7 recommended range (\>=140 mmHg) who recently entered home care service. The NP only program will provide a 30 day intervention while the NP/HC team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. As applicable, the HC will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.

Interventions

BEHAVIORALNurse Practitioner Only
BEHAVIORALNurse Practitioner + Health Coach

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
NYU Langone Health
CollaboratorOTHER
Hebrew Home at Riverdale
CollaboratorOTHER
Columbia University
CollaboratorOTHER
Visiting Nurse Service of New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Newly admitted to the VNSNY post acute care program * 21 years of age or older * Black and/or Hispanic * Speaks English or Spanish * History of stroke or transient ischemic attack (TIA) * Hypertension diagnosis * Average screening systolic BP \>= 140 mmHg * Is available to participate in intervention activities during the study timeframe if randomized to treatment group

Exclusion criteria

* Dialysis * End stage renal disease * Kidney transplant * Severe heart failure * Significant cognitive impairment. Unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention * Significant verbal speech impairment. Unable to participate in intervention telephone sessions * Patients with upper arm circumference outside of valid use parameters for the automated device used for eligibility screening

Design outcomes

Primary

MeasureTime frameDescription
Reduction of systolic blood pressureBaseline to 3 and 12 months.Patients randomized to the NP only and the NP+HC transitional care interventions will have greater 3 and 12 month reduction in SBP than patients in Usual Home Care.

Secondary

MeasureTime frameDescription
Cost-effectiveness of NP-only and NP+HC relative to UHCVNSNY home care admission to 3 and 12 months post admissionBoth interventions will be more costly but more cost-effective than usual home care.
Influence on post-stroke patients' function and health-related quality of life (QoL)Baseline to 3 and 12 monthsBoth interventions will yield significant comparative improvements in function and health-related QoL; NP+HC will be more effective than NP-only.

Other

MeasureTime frameDescription
Moderators and mediators that may affect treatment outcomesBaseline to 3 and 12 monthsExploratory aim to examine potential moderating/mediating variables which may include: moderators - race/ethnicity (i.e., Black/Hispanic differences), baseline HTN severity (Stage I vs. Stage II); mediators - 1) changes in health behaviors (i.e., diet, physical activity, weight loss, medication adherence); and 2) antihypertensive medication intensification (i.e., adding, changing dose, or changing class of medications).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026