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Completed

NCT Number: NCT01918891

Center for Stroke Disparities Solution - Community Transitions Intervention

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Visiting Nurse Service of New York

New York, 10001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse Practitioner Only

Behavioral

Nurse Practitioner + Health Coach

Behavioral

Primary outcomes

  1. Reduction of systolic blood pressure

    Time frame: Baseline 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 outcomes

  1. Cost-effectiveness of NP-only and NP+HC relative to UHC

    Time frame: VNSNY home care admission to 3 and 12 months post admission

    Both interventions will be more costly but more cost-effective than usual home care.

  2. Influence on post-stroke patients' function and health-related quality of life (QoL)

    Time frame: Baseline to 3 and 12 months

    Both interventions will yield significant comparative improvements in function and health-related QoL; NP+HC will be more effective than NP-only.

Other outcomes

  1. Moderators and mediators that may affect treatment outcomes

    Time frame: Baseline to 3 and 12 months

    Exploratory 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).

Sponsors and collaborators

Lead sponsor

Visiting Nurse Service of New York

Other

Collaborators

  • Columbia University
  • Hebrew Home at Riverdale
  • NYU Langone Health
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Acronym: CSDS

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2013
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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