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

August 5, 2013
March 28, 2014
September 2012
June 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01918891 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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).
Same as current
 
Center for Stroke Disparities Solution - Community Transitions Intervention
Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Hypertension
  • Stroke
  • Transient Ischemic Attack
  • Behavioral: Nurse Practitioner Only
  • Behavioral: Nurse Practitioner + Health Coach
  • 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.
    Interventions:
    • 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.
    Intervention: Behavioral: Nurse Practitioner Only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
495
August 2017
June 2016   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact: Margaret M McDonald, MSW 212-609-5761 Margaret.McDonald@VNSNY.org
Contact: Melissa A Trachtenberg 212-760-3112 Melissa.Trachtenberg@vnsny.org
United States
 
NCT01918891
I12-004, 1U54NS081765
Yes
Visiting Nurse Service of New York
Visiting Nurse Service of New York
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • New York University School of Medicine
  • The Hebrew Home At Riverdale
  • Columbia University
Principal Investigator: Penny H Feldman, PhD Visiting Nurse Service of New York
Visiting Nurse Service of New York
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP