Visiting Nurse Service of New York
New York, 10001, United States
NCT Number: NCT01918891
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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Notify Me21 year and older
All sexes
Interventional
Not applicable
New York, 10001, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
Visiting Nurse Service of New York
Other
Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)
Acronym: CSDS
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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