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

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

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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 Save

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

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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 Save

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

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Profiles_link
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 Save

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

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Profiles_link
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

An International, Double-blind, Randomised, Placebo-Controlled Phase III Study to Evaluate the Effect of Dapagliflozin on Reducing CV Death or Worsening Heart Failure in Patients with Heart Failure with Preserved Ejection Fraction (HFpEF) DELIVER - Dapagliflozin Evaluation to Improve the LIVEs of Patients with PReserved Ejection Fraction Heart Failure Save

Date Added
November 13th, 2018
PRO Number
Pro00083036
Researcher
Sheldon Litwin

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Keywords
Diabetes, Heart, Hypertension/ High Blood Pressure
Summary

Volunteers are being asked to participate in a clinical research study to find out if the drug dapagliflozin is safe and effective compared to placebo (an inactive substance) in the treatment of people with heart failure with preserved ejection fraction (ability of the heart to relax and squeeze to pump out blood). AstraZeneca is doing this research to find out if the new medication called dapagliflozin will work and be safe for the treatment of heart failure in addition to standard therapy used for treatment of heart failure. The study is planned to go on for about 33 months and include 4700 patients from about 21 countries.

This research study is carried out to see if dapagliflozin is effective in preventing worsening of heart failure and improving survival in patients with heart failure and preserved systolic function. The placebo tablet will look identical with the dapagliflozin tablet. During the study participants will either receive dapagliflozin 10 mg once a day or an identical-looking placebo once a day. Which study drug subjects will receive throughout the study is decided at random by a computer (purely by chance, like the tossing of a coin). Subjects have a 50% chance of receiving dapagliflozin and a 50% chance of receiving placebo. Subjects and the study doctor will not know which study drug the participants receive.

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

Changes in Optic Nerve Sheath Diameter in Preeclamptic patients with Severe Features by Neurologic Criteria versus Diagnosis Without Neurologic Criteria, Compared to Controls. Save

Date Added
November 7th, 2018
PRO Number
Pro00078977
Researcher
Mary Sterrett

List of Studies

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Keywords
Central Nervous System, Hypertension/ High Blood Pressure, Non-interventional, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Preeclamptic patients will have an ultrasound done of their eyes, to look at the size of the nerve behind the eye. We will also recruit women without preeclampsia to be a comparison group.

Institution
MUSC
Recruitment Contact
Mary Sterrett
8434940554
sterretm@musc.edu

Using Portable Telemedicine to Connect homebound patients to medical and social resources (Connected Home) Save

Date Added
September 19th, 2018
PRO Number
Pro00078976
Researcher
Gayenell Magwood

List of Studies


Profiles_link
Keywords
Diabetes, Hypertension/ High Blood Pressure
Summary

This is a research study to find out how acceptable and how to deliver a Home Care Tele-Visits with adults diagnosed with Diabetes Mellitus (Diabetes) and/or Hypertension (high blood pressure). This study will consist of three at home visits with a Medical Tele-Assistant. Each visit will be scheduled to accommodate the participant's schedule and will be about 2-3 weeks apart. During the 2nd and 3rd visit the participant will able to use mobile technology to visit with their doctor and community/social resources (family member or friend). Participants will not be expected to pay for these in-home visits, and will be compensated for their time and participation.

This study is a pilot project, meaning that the goal is to gather data about how easily technology can be used in the home to provide access to health care providers, and social/community resources. Participants may benefit from participating in this study, but that cannot be guaranteed. There are minimal risks associated with participating in this study, such as a loss of privacy while using the Telemedicine System.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-5032
slans@musc.edu

Immune response to pneumococcal vaccination in aging renal transplant recipients Save

Date Added
June 19th, 2018
PRO Number
Pro00077548
Researcher
Maria anna Westerink

List of Studies

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Keywords
Aging, Diabetes, Geriatrics, Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Immune System, Kidney, Transplant, Vaccine
Summary

We will study how well the relatively new FDA approved pneumonia vaccine can protect older renal transplant recipients against pneumococcal illness. We will specifically study the group of renal transplants in whom the cause of renal failure was either diabetes mellitus II and/or hyoertension. We will compare the findings against those we find in younger renal transplant recipients, older healthy individuals and older persons with diabetes but normal kidney function. Healthy younger individuals will serve as controls for optimal vaccine response.

Institution
MUSC
Recruitment Contact
Myroslawa Happe
843-792-2218
soloshch@musc.edu

Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor Save

Date Added
March 27th, 2018
PRO Number
Pro00070627
Researcher
Ashley Wabnitz

List of Studies

Silhouette
Keywords
Hypertension/ High Blood Pressure, Stroke
Summary

This racial disparity in stroke is more prominent in the Southeastern region of the US, where 3 states have long been recognized as representing the ?buckle' of a ?stroke belt'. One of these 3 states is South Carolina, where our proposed study will take place. Stroke (including recurrent stroke) is highly preventable via control of high blood pressure. Mobile health (mHealth) technology may offer a promising approach for enhancing blood pressure control after stroke. mHealth tools provide an easy-to-use self-management system that permits optimal medication adherence. PACESETTER will conduct an implementation trial of the intervention
(personalized phone text messaging and home BP monitoring) vs. usual care in 200 recent stroke patients with HTN recruited across the two of the three main safety net hospitals in the state of SC. The project will explore whether the intervention vs. standard care is associated with a reduction in cardiovascular event-related emergency department encounters and re-hospitalizations within 12 months and whether the intervention has potential to reduce vascular events.

Institution
MUSC
Recruitment Contact
Ariana Tinker
8437926881
tinkera@musc.edu

IMPACT OF INTEGRATED HIV/NCD SCREENING ON HIV TESTING UPTAKE AND ENGAGEMENT IN HIV CARE: AN RCT IN KISARAWE, TANZANIA Save

Date Added
July 5th, 2017
PRO Number
Pro00064733
Researcher
Michael Sweat

List of Studies


Profiles_link
Keywords
Diabetes, HIV / AIDS, Hypertension/ High Blood Pressure
Summary

HIV testing is often shunned in community settings due to the stigma of HIV-centric services. Our recent pilot study strongly suggest that integration of a package of screening that include HIV, diabetes, and hypertension hold promise of substantially increasing the uptake of HIV testing while simultaneously providing direly needed community screening for non-communicable disease (NCDs) like diabetes and hypertension, which themselves are at epidemic levels in Sub-Saharan Africa. This study will examine whether integrating HIV screening with NCD screening will improve uptake of HIV testing and whether integrating HIV and NCD care will improve retention.

Institution
MUSC
Recruitment Contact
Michael Sweat
843-876-1082
sweatm@musc.edu

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