Center for Stroke Disparities Solution - Community Transitions Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

495 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness Trial of Youth Suicide Prevention Delivered by Teen Peer Leaders

NCT02043093

Suicide Prevention

COMPLETED NA

Implementation of Suicide Risk Models in Health Systems

NCT06060535

Suicide, Attempted Suicide, Fatal

ENROLLING_BY_INVITATION NA

A Novel Cognitive Reappraisal Intervention for Suicide Prevention

NCT03026127

Suicide Prevention

COMPLETED NA

Examining the Impact of Family Connectors

NCT05195489

Caregiver Stress Syndrome

COMPLETED NA

Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff

NCT02981420

Suicide and Self Harm

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Stroke Transient Ischemic Attack

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Home Care

Regardless of study arm, all patients will receive usual home health services: a physician-ordered plan of care; skilled nursing and/or therapy services as prescribed by the MD; patient education, monitoring and hands-on care; and home health aide services depending on functional deficits and availability of unpaid caregivers.

Group Type NO_INTERVENTION

No interventions assigned to this group

Nurse Practitioner + Health Coach

The NP + HC arm will include the same protocol as the NP only arm plus 30 additional days of support. The HC will pick up the case after the initial 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.

Group Type EXPERIMENTAL

Nurse Practitioner Only

Intervention Type BEHAVIORAL

Nurse Practitioner + Health Coach

Intervention Type BEHAVIORAL

Nurse Practitioner Only

The NP only program will provide a 30 day intervention via in-home and telephone encounters for patients randomized to this group. 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.

Group Type EXPERIMENTAL

Nurse Practitioner Only

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nurse Practitioner Only

Intervention Type BEHAVIORAL

Nurse Practitioner + Health Coach

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No