Center for Stroke Disparities Solution - Community Transitions Intervention (CSDS)
|ClinicalTrials.gov Identifier: NCT01918891|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2013
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Stroke Transient Ischemic Attack||Behavioral: Nurse Practitioner Only Behavioral: Nurse Practitioner + Health Coach||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||495 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
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
- 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.
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918891
|United States, New York|
|Visiting Nurse Service of New York|
|New York, New York, United States, 10001|
|Principal Investigator:||Penny H Feldman, PhD||Visiting Nurse Service of New York|