Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.

Date Added
May 6th, 2021
PRO Number
Pro00110062
Researcher
Gayenell Magwood

List of Studies


Keywords
Cardiovascular, Coronavirus, Diabetes, Hypertension/ High Blood Pressure, Minorities, Stroke
Summary

Underserved, racial and ethnic minority communities are experiencing higher rates of COVID-19 cases and associated mortality compared to whites due to long standing social and structural inequities that also drive disparities in chronic diseases such as stroke, cardiovascular disease, diabetes, and hypertension. Patients with underlying chronic diseases who are recovering from COVID-19 depend on the support of family and friends (informal caregivers/care partners) who are being exposed to the same pandemic and racial stressors, exposure that can affect the health and quality of life of both partners. The primary goal of this study is to test the efficacy of an adapted, telehealth-enhanced intervention that targets barriers impacting family illness management behaviors of Black/African American (AA) adult COVID-19 survivors and carepartner dyads for improved quality of life and COVID/chronic illness health related outcomes.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
8437920685
magwoodg@musc.edu

Pulmonary Vascular Complications of Liver Disease 3 (PVCLD3)

Date Added
January 22nd, 2021
PRO Number
Pro00103260
Researcher
David Koch

List of Studies


Keywords
Hypertension/ High Blood Pressure, Liver, Men's Health, Pulmonary, Transplant, Vascular
Summary

This is a prospective cohort study of subjects with portal hypertension to examine whether increased sphingosine 1 phosphate : ceramide ratio and circulating bile acids are associated with HPS in patients with advanced liver disease. The study will consist of 400 individuals who are evaluated for liver transplantation at the Field Centers. This population has advanced liver disease and will represent the population with cirrhosis at the Centers. As is considered standard of clinical care for these patients and required for liver transplant evaluation, patients will undergo phlebotomy, interviews, pulmonary function testing, echocardiography, and arterial blood gas sampling at their initial evaluation. During the clinical phlebotomy, additional samples will be drawn for research purposes. If any of these procedures does not occur during the clinical visit, it may be conducted for research purposes. Six minute walk testing, frailty scales, SF36, and optional actigraphy, all of which are research-only assessments, will be performed at baseline. Subjects will then be followed via phone for the duration of the study period.

Institution
MUSC
Recruitment Contact
Christian Conley
(843)876-4273
conleyc@musc.edu

Disparities in Hypertension Risk Among Young Adults: The Role of Epigenetics

Date Added
November 2nd, 2020
PRO Number
Pro00100786
Researcher
Joy Jones Buie

List of Studies


Keywords
Hypertension/ High Blood Pressure
Summary

This clinical research study is being done to evaluate the association between high blood pressure and mental stress in a diverse population of bachelor's degree-seeking college students between the ages of 18-24 years old. This clinical research study requires two study visits over the span of two weeks. Volunteers will be asked to answer questions about their mental stress, lifestyle, behaviors and socioeconomic status. Participants will have body fat, blood pressure and blood vessel stiffness measured as well as a blood sample collected for testing.

Institution
MUSC
Recruitment Contact
Joy Buie
843-792-6098
jonejn@musc.edu

ALgorithm using LINQ Sensors for EValuatIon And TreatmEnt of Heart Failure (ALLEVIATE-HF)

Date Added
September 22nd, 2020
PRO Number
Pro00103625
Researcher
Michael Field

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study involves individuals who have been diagnosed with heart failure, a condition where the heart does not pump blood as well as it should. For this study, a new software program called ALLEVIATE-HF will be studied to see if the software program can help predict worsening heart failure symptoms. The software program will be put onto a medical device called the Reveal LINQ Insertable Cardiac Monitoring (ICM) System. Some participants may already have the Reveal LINQ ICM. If a participant does not already have a Reveal LINQ ICM, then the device will be inserted under the skin. The ALLEVIATE-HF software will help the device identify problems related to heart failure. The device will collect data such as the subjects heart rate and activity level. The information gathered by this system will help the study doctor/healthcare provider and the study team understand an individual subject's risk of having a heart failure event (worsening heart failure symptoms requiring additional treatment or hospitalization) so that steps can be taken to manage their heart failure.

The study will last at least 7 months but may last up to 3 years. There will be at least 2 but up to 4 visits during the study.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial (NanoSense)

Date Added
April 28th, 2020
PRO Number
Pro00098518
Researcher
Adrian Van Bakel

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This study is being done to find out if we can better monitor subjects with heart failure with the use of a wearable device (called SimpleSense garment) that can monitor multiple factors of heart failure that affect the body such as heart rate, activity, heart rhythm, and respiratory rate. Participants will wear the SimpleSense garment for 90 days for at least 12 hours daily. Participation in the study will include two research clinic visits and 2 phone calls over 4 months. Participants will be compensated for time and travel.

Risks of this study include loss of confidentiality, blood draw and skin irritation from wearing the garment.

Institution
MUSC
Recruitment Contact
Jacques Johnson
843-876-5873
johnjacq@musc.edu

RELIEVE-HF TRIAL: REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

Date Added
January 14th, 2020
PRO Number
Pro00095660
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Heart, Hypertension/ High Blood Pressure
Summary

The purpose of the study is to evaluate the safety and how well the V-Wave Interatrial Shunt works. The study will also look at information obtained from the tests performed to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 1 year to up to 7 years depending on randomization group. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks. There will be a minimum of 10 or up to 15 planned research clinic visits. Subjects will have 1 overnight hospital stay for the study related RHC and research procedure. Due to the COVID-19 pandemic, study participants may be discharged the same day when necessary. Each participant will receive a phone call between all study visits.

Subjects will have a 50:50 chance of receiving the Shunt during the randomization procedure (like the flip of a coin). Neither the subject, nor the blinded study doctor or blinded study coordinator will know which group subjects are in. Participants will be randomized to either the treatment group (and receive the Shunt) or the control group (and not receive the shunt). Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@musc.edu

Characterization of patient-, provider-, and clinic-level factors associated with implementation, clinical outcomes, and sustainability of diabetes remote patient monitoring

Date Added
January 3rd, 2020
PRO Number
Pro00094517
Researcher
Elizabeth Kirkland

List of Studies


Keywords
Diabetes, Hypertension/ High Blood Pressure, Minorities
Summary

The purpose of this formative research is to explore and understand patient-, provider-, and systems-level characteristics that affect the sustainability and success of remote patient monitoring technology applied to diabetes chronic care. This will be completed through evaluation and analysis of the Technology Assisted Case Management in Low Income Adults with Type 2 Diabetes (TACM-2) implementation program. TACM-2 utilizes remote patient monitoring (RPM) of diabetes and hypertension to augment regular clinical care, with the ultimate goal of improving health outcomes particularly for low-income patients regardless of geographic location.

This exploratory study's broad goal is to characterize key barriers and facilitators to RPM use over time through a mixed methods design. We will utilize data gathered as part of an ongoing quality improvement program, TACM-2, to provide quantitative data on RPM uptake and effectiveness. We will also obtain qualitative and quantitative data from participating patients and healthcare teams. Our objectives are to assess:
1) patient-level variables that are associated with sustained device use and clinical outcomes over time,
2) patterns of device uptake and data transmission across South Carolina as markers of scalability and sustainability, and
3) patient-, clinic- and system-level barriers and facilitators of RPM implementation.

Institution
MUSC
Recruitment Contact
Ryan Kruis
843-792-4703
kruis@musc.edu

Reducing Disparities in Living Donation Among African Americans

Date Added
January 2nd, 2020
PRO Number
Pro00092908
Researcher
Derek DuBay

List of Studies


Keywords
Diabetes, Hypertension/ High Blood Pressure, Kidney, Transplant
Summary

Kidney donation from a living donor provides the kidney recipient with the best chance of a longterm survival of the transplanted kidney. White End Stage Renal Disease (ESRD) patients are 4 times more likely to recieve a living donor kidney than are African American (AA) ESRD patients. There are many reasons for this disparity in obtaining the benefits of living donation for AAs, including lack of knowledge regarding the living donation process. This study will provide a web-based educational intervention to overcome this knowledge deficiency with the hope that there will be an increase in patient interest in living donation which will result in more living donation kidney transplant inquiries by patients' family or friends.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
843-792-5405
morinelt@musc.edu

Community Navigation to Address Hypertension Management in Rural Belize

Date Added
December 6th, 2019
PRO Number
Pro00093670
Researcher
Jessica Chandler

List of Studies


Keywords
Hypertension/ High Blood Pressure
Summary

We will conduct key informant interviews (KII) with a diverse group of healthcare administrators, healthcare providers, community healthcare workers and patients/caregivers. The purpose of these KIIs is to 1.) inform the development of a hypertension management intervention and training materials adapted for cultural and contextual relevance, and 2.) the optimal research design for future, larger-scaled, multi-village interventions. We will conduct up to 30 interviews including up to 15 administrators/clinical team members including community health care workers and 15 patients until we reach thematic saturation.
The administrator and clinician interviews will query structures and processes currently in place for diagnosing and managing hypertension in rural Belizean adults. Additionally, we will inquire about barriers and facilitators regarding medication management for hypertension, perceptions of caring and follow-up, patients' needs and wants related to care from their physicians. We will also include questions and discussions regarding clinicians' preferences for hypertension management and frequency and format of patient data delivery from the community health care workers.
Patient interviews will query current hypertension management strategies including self –reported medication adherence estimations, education and support needed, quality of current care model, and suggestions/insight into best approaches for utilizing the navigators (e.g., where best to centrally station them in the community, how often to send navigators, best/worst times of days, etc.).

Institution
MUSC
Recruitment Contact
Luke Sox
843-792-9500
soxl@musc.edu

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension

Date Added
September 24th, 2019
PRO Number
Pro00091232
Researcher
Thomas Todoran

List of Studies


Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

This is a study for patients with high blood pressure. The purpose of this study is to evaluate the safety and effectiveness of renal denervation while you are still on your blood pressure medications. Renal denervation is a procedure that destroys the nerve fibers that run along the kidney blood vessels interrupting nerve signals that may cause high blood pressure.The purpose of the treatment (renal denervation) is to lower blood pressure. You will undergo renal angiography (RA), which you may or may not receive the study treatment (depending upon your study assignment). The sponsor has manufactured a new drug/device combination product called the Peregrine System™ Kit (also referred to as the Peregrine Kit). The Peregrine Kit contains a device, the Peregrine System™ Infusion Catheter (also referred to as the Peregrine Catheter), and a drug dehydrated alcohol for injection (also referred to as alcohol). Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces your blood pressure. The participant will be asked to return to the doctor's office for follow-up visits at 4 and 8 weeks, 3, 4, 5 and 6 months, and 1, 2, and 3 years after the procedure. At the 1 year visit, the participant will find out if he/she got the treatment, and if he/she did not, they can choose to cross-over to the treatment if they still meet eligibility criteria.

Institution
MUSC
Recruitment Contact
Anthony Awkar
8438765009
awkar@musc.edu



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