
Cardiovascular Risk Screening and Risk Reduction in Women Vets
Cardiovascular DiseasesHypertension6 moreBackground: Women Veterans are the fastest growing segment of Veterans Health Administration (VHA) users. This dramatic growth has created challenges for VHA. Gender disparities persist in cardiovascular (CV) and diabetes risk factor control, and rates of depression, anxiety, and mental health comorbidity are disproportionately high among women Veterans. Furthermore, a high rate of women Veterans' attrition from VA care, along with organizational barriers to care, substantiate that organizational changes are needed in order to engage and retain women Veteran VHA users in evidence-based, patient-centered care. Objectives: The Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI addresses VHA Blueprint for Excellence Strategy 6, by advancing "personalized, proactive, patient-centered" care models, and Transformational Strategy 7.2.g by implementation of innovative care models in women Veterans' health care." The EMPOWER QUERI Program is designed to improve women Veterans' engagement and retention in evidence-based care for three high priority health conditions, i.e., prediabetes, cardiovascular, and mental health. To achieve this impact goal, we propose a cohesive portfolio of projects with the following aims: (1) To use an evidence-based implementation strategy that emphasizes local tailoring of care models, multilevel stakeholder engagement, and systematic evaluation of complex implementation processes in order to enrich organizational capacity for innovations in women Veterans' VHA health care; (2) To implement personalized, proactive, patient-centered innovations in VHA women's health that are acceptable, feasible, satisfactory, relevant, and effective for both providers and patients, thereby encouraging women Veterans' engagement and retention and sustainability of the innovations; and, (3) To generate implementation "playbooks" for our partners that are scalable and serve as guidance for future implementation of a broader array of evidence-based women's health programs and policy. Methods: Three projects will be conducted by an experienced multidisciplinary team. "Tailoring VA's Diabetes Prevention Program to Women Veterans' Needs" is a one-year QI project to be conducted in VA Greater Los Angeles women's health clinics. Women Veterans with prediabetes will select an in-person, peer-led or online gender-specific, evidence-based diabetes prevention program to address their risk behaviors and health conditions. "Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans" will increase identification of CV risk among women Veterans, enhance patient/provider communication and shared decision-making about CV risk, and provide a supportive, coordinated health coaching intervention to facilitate women Veterans' engagement and retention in appropriate health services. "Implementation of Tailored Collaborative Care for Women Veterans" will evaluate implementation of an evidence-based collaborative care model tailored to enhance provider- and system-level capabilities to address women Veterans' anxiety and depression treatment needs, thereby improving organizational primary care-mental health integration (PC-MHI) effectiveness and women Veterans' engagement and retention in PC-MHI. Both implementation research studies will use a modified stepped wedge design and will apply the evidence-based Replicating Effective Programs (REP) implementation strategy. Mixed methods implementation evaluations will focus on investigating primary implementation outcomes of adoption, acceptability, feasibility, and reach. Multilevel stakeholder engagement will be prioritized. Program-wide organizational-, provider-, and patient-level measures and tools will be utilized to enhance synergy, productivity, and impact. As a coherent program of women's health implementation research and quality improvement, the proposed EMPOWER QUERI will constitute a major milestone in achieving BPE strategies and realizing women Veterans' engagement and, ultimately, empowerment in our VHA system.

Yoga Poses and Breath Control Cardiovascular Changes in Hypertensive Post-Menopause Women
HypertensionPostmenopausal SymptomsAutonomic and endothelial imbalance in post menopause women raise the need to manage cardiovascular risk. Yoga poses and breathing control present controversial results on prevention and treatment of hypertension.. The aim of this study is to compare the effect of 12 week intervention based on yoga poses and their muscle contractions known as bandhas (pelvic floor, core and throat/neck) and ujjayi pranayama (victorious breath) on autonomic modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function of hypertensive post-menopausal women.

Tailored Messaging to Reduce Sodium Intake
HypertensionThe proposed study will determine the effectiveness of a mobile application location-based tailored notification message system in helping hypertensive patients reduce dietary sodium intake and feel more confident in following a low sodium diet.

Safety and Tolerability of Krill Powder Supplement in Slightly Overweight People With Moderately...
Adverse Drug EventSide Effects of DrugsThe aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease. The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56. As a primary endpoint of the study, the total number of reported adverse events were compared in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of placebo for the 8-week follow-up period.

Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to...
HypertensionDespite a large diffusion for generic anti-hypertensive, they are not currently used. Clinical validation studies could be better to convince users and prescribers than pharmacologic validation only. A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place in real conditions of care for hypertensive patients, for a manometer control criteria. The aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.

The Effects on Blood Pressure Control, Pulse Wave Velocity, as Well as Safety and Tolerability of...
HypertensionThe purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.

This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects...
HypertensionPulmonaryIn this trial the effects of the inhaled drug BAY1237592 will be studied in patients with high blood pressure in the pulmonary blood vessels due to Pulmonary Arterial Hypertension (PAH) and due to Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Pulmonary hypertension is characterized by the elevation of pressure in the pulmonary arteries (PAP) and of the pulmonary vascular resistance (PVR) leading to increased workload of the right chamber of the heart to eject blood against this elevated resistance. The goal of this study is to measure the safety and tolerability of the drug as well as the reduction of the PVR at different doses In Part A patients without specific treatment for PH (untreated patients) will be tested. In Part B also patients stably pre-treated with specific PH drugs will be studied in combination with the new inhaled drug

Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension...
Tourniquet HypertensionIntraoperative Hypertension2 moreThe purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.

Evaluation of a Transmedial Psychoeducational Program to Improve Pharmacological Adherence
Essential HypertensionPopulation in Chile has experienced an accelerated process of demographic aging, which leads to changes in the composition of morbidity and mortality, with chronic noncommunicable diseases currently predominating. One of the main problems in the treatment of people with chronic and asymptomatic pathologies such as essential arterial hypertension is the lack of pharmacological adherence, where approximately 50% farewell to the treatment, while the remaining 50% partially adheres, does not adhere or interrupt within the first year. The solution is a Psychoeducational Transmedial Program to improve pharmacological adherence (PTA), as a support to the current treatment found in centers of primary health (CESFAM). The PTA program offers health promotion and education proposals through video capsules transmitted in CESFAM. The full PTA program also includes an AFAM-Health phone application in which older adults can know and control the administration of their medications, schedule medication registration alerts, have access to healthy life information and pathology information, Incorporated a community through a chat that generates support and accompaniment among the participants themselves. The aim of the study is to evaluate if Transmedial Psychoeducational Program improves the pharmacological adherence of the antihypertensive treatment in elderly people receiving medical attention at CESFAM Hualpen, in Chili. A clinical trial was conducted with 3 parallel groups of older adults diagnosed with Essential Arterial Hypertension. There were 2 treatment groups (A and B) and a control group (C). Group A was exposed to the full PTE transmedial psychoeducational program that includes a cell phone with the application developed to improve adherence and data plan. Group B received the program without the mobile application. All participants were given a Morisky-Green test to measure pharmacological adherence and an instrument developed by the clinical team to measure the biopsychosocial characteristics of elderly under study. t is expected to find that the pharmacological adherence of those receiving the full PST is significantly superior to the control group, and those who receive the partial PST are significantly superior to the control group.

An mHealth Strategy to Reduce Pre-Eclampsia and Infant Death in Tanzania
Pre-EclampsiaEclampsia2 moreThe core of this study is a cluster randomized controlled trial (RCT) of antenatal clinics which are located in four districts in Tanzania. We are conducting an effectiveness (pragmatic) rather than an efficacy (explanatory) trial because we are looking to measure the degree of benefit under 'real world' conditions. Although pragmatic and carried out in real world conditions, the proposed size and scope of the trial will allow us to achieve a robust evaluation of outcomes and determine the effectiveness of our intervention. A cluster design is the most appropriate type of methodology (rather than individual randomization by pregnant woman) as the intervention can be delivered to the entire health facility (of those facilities in the intervention group). The intervention is to implement an mHealth strategy to improve detection and management of PE (pre-eclampsia). This study is a multi-level, mixed-methods design that includes a cluster-randomized controlled trial (RCT) of antenatal clinics in rural Tanzania. Thirty health facilities have been randomized to control facilities and thirty facilities have been randomized to intervention clinics. All randomized clinics have upgraded antenatal care (ANC) and skilled birth attendants present. Nurses in the intervention clinics in this cluster arm will receive mHealth-based education in detection and management of PE and will be instructed and encouraged to follow a guideline-driven approach supported by mHealth (educational modules that provide decision support and reminders through the facility smartphone/tablet). At all antenatal visits, pregnant women will have their blood pressures measured and urine assessed for proteinuria, and, the result will be automatically sent by SMS (short message service) with a unique patient identifier to a central site for monitoring and tracking. Community Health Workers (CHWs) linked to the facility site and local communities will be instructed on which women to have follow-up visits within their communities. For all those women found to be at risk for PE (as well as other high risk maternal conditions), an SMS will be sent to the CHW, and, the nurses at the ANC recommending timely follow-up and protocol steps for management at that facility or for transfer for further monitoring and management at a higher-level facility. The nurses participating in the study have been drawn from the health facilities themselves, in both control and intervention arms. Quantitative data will be collected on an ongoing basis through the mobile platform. Women are eligible for recruitment between 15 weeks and 36 weeks gestation.