Management of HTN Patients by CNS in Military Setting - A Supplemental Study

This competing supplemental application requests support to significantly expand the scope of the recent Tri-Service funded study "Management of Hypertensive Patients by Clinical Nurse Specialist in a Military Setting" (MDA 905-98-Z-0010, N98-003). In this trial 186 hypertensive patients, 18 years or older, are randomized to usual care (UC) group (n=93) or to the Clinical Nurse Specialist (CNS) group (n=93) where comprehensive, high blood pressure (HBP) care is being implemented by a clinical nurse specialist practicing in collaboration with primary care providers. It is proposed that each patient will be followed for 12 months. The primary outcome is the extent of blood pressure lowering in the two groups. The supplemental study incorporates compelling new scientific discoveries and recently improved methodologies to assess genetic polymorphisms, cardiovascular, and renal abnormalities associated with hypertension, and thereby enrich the biological information obtained within the clinical trial. The supplement will not alter the main trial objectives, aims, or design in any way. Rather, it expands the assessment and analysis by adding physiologic variables and genetic variables associated with hypertension. Physiological variables of echocardiogram, EKG, proteinuria are added to evaluate cardiac end-organ damage. Genetic variables are added to evaluate patient's response to treatment. The proposed supplemental study has two major goals: 1) to assess the effects of a CNS intervention (a comprehensive, educational-behavioral treatment program delivered by a Clinical Nurse Specialist) on controlling hypertension (HTN) and subsequent cardiovascular and renal parameters; and 2) to determine whether significant genetic factors are associated with HTN which influence cardiovascular abnormalities. The strength of this supplemental proposal is that it recognizes a unique opportunity to address important biologic factors associated with hypertension within an ongoing Tri-Service funded randomized clinical trial in which 186 hypertensive military beneficiaries are being enrolled. This trial investigates the effectiveness of advanced practice nursing for comprehensive HBP care. For the patients enrolled in the ongoing clinical trial (N=186) it will provide as much as a 2 year follow-up instead of 12 month follow-up.

Final report is available on NTRL: https://ntrl.ntis.gov/NTRL/dashboard/searchResults/titleDetail/PB2013104...