Center for Stroke Disparities Solution - Community Transitions Intervention (CSDS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Visiting Nurse Service of New York
Sponsor:
Collaborators:
New York University School of Medicine
The Hebrew Home At Riverdale
Columbia University
Information provided by (Responsible Party):
Visiting Nurse Service of New York
ClinicalTrials.gov Identifier:
NCT01918891
First received: August 5, 2013
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Hypertension
Stroke
Transient Ischemic Attack
Behavioral: Nurse Practitioner Only
Behavioral: Nurse Practitioner + Health Coach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)

Resource links provided by NLM:


Further study details as provided by Visiting Nurse Service of New York:

Primary Outcome Measures:
  • Reduction of systolic blood pressure [ Time Frame: Baseline to 3 and 12 months. ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Cost-effectiveness of NP-only and NP+HC relative to UHC [ Time Frame: VNSNY home care admission to 3 and 12 months post admission ] [ Designated as safety issue: No ]
    Both 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) [ Time Frame: Baseline to 3 and 12 months ] [ Designated as safety issue: No ]
    Both interventions will yield significant comparative improvements in function and health-related QoL; NP+HC will be more effective than NP-only.


Other Outcome Measures:
  • Moderators and mediators that may affect treatment outcomes [ Time Frame: Baseline to 3 and 12 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 495
Study Start Date: September 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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.
Behavioral: Nurse Practitioner Only Behavioral: Nurse Practitioner + Health Coach
Experimental: 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.
Behavioral: Nurse Practitioner Only

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918891

Contacts
Contact: Margaret M McDonald, MSW 212-609-5761 Margaret.McDonald@VNSNY.org
Contact: Melissa A Trachtenberg 212-760-3112 Melissa.Trachtenberg@vnsny.org

Locations
United States, New York
Visiting Nurse Service of New York Recruiting
New York, New York, United States, 10001
Principal Investigator: Penny H Feldman, PhD         
Sponsors and Collaborators
Visiting Nurse Service of New York
New York University School of Medicine
The Hebrew Home At Riverdale
Columbia University
Investigators
Principal Investigator: Penny H Feldman, PhD Visiting Nurse Service of New York
  More Information

Additional Information:
No publications provided

Responsible Party: Visiting Nurse Service of New York
ClinicalTrials.gov Identifier: NCT01918891     History of Changes
Other Study ID Numbers: I12-004, 1U54NS081765
Study First Received: August 5, 2013
Last Updated: March 28, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Visiting Nurse Service of New York:
stroke
transient ischemic attack
High blood pressure
Hypertension

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Hypertension
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 16, 2014