Unload Heart Failure

Heart failure is a major clinical and public health challenge associated with high morbidity, mortality, and costs. Diabetes (DM) and low socioeconomic status (SES) are each independent risk factors for HF, and both factors together have a synergistic association with incident HF. A major functional consequence of these associations is impaired cardiorespiratory fitness. Additionally, low SES and DM are over-represented among racial and ethnic minorities and are, therefore, causes of HF disparities.

A healthy lifestyle, particularly exercise and risk factor control, can reduce heart failure risk, but people with low SES face complex barriers to healthy behavior. Strategies to reduce heart failure risk in individuals with low SES need to be multi-level, targeting individuals, support networks, community resources, and healthcare access.

We aim to adapt an evidence-based multi-level intervention (problem-solving training, use of community exercise facilities, and support from community health workers) for persons with low SES, DM, obesity, and early cardiac dysfunction, with input and feedback from community partners to increase acceptability and practicality.

We will conduct a randomized controlled trial to determine if a six-month multilevel intervention of problem-solving training, community health worker support, and use of community facilities improves cardiorespiratory fitness and related outcomes in those with low SES, DM, obesity, and early cardiac dysfunction more than enhanced education and connection with community health programs.

We will adapt the Problem-Solving intervention for patients with low SES, DM, obesity and early cardiac dysfunction, with an emphasis on improving fitness and risk factor control. We will incorporate the principles of community-based participatory research (CBPR) and patient-centered outcomes research (PCOR) to ensure that the intervention addresses multiple barriers to DM self-management, is patient-centered and has a health equity focus.

Chiadi Ndumele, MD, PhD, MHS
Principal Investigator
Leads all aspects of the study, including the design, analyses and manuscript preparation, IRB approval processes, EMR based analyses, coordination with potential community partners, recruitment and performance of the interventional study and reporting of results.

Lisa Cooper, MD, MPH
Principal Investigator
Co-leads all aspects of the project, with a particular role in the interactions with potential community partners and design and implementation of the clinical trial.

Josef Coresh, MD, PhD
Co-Investigator
Provides biostatistical expertise concerning study design and assists in the performance of epidemiologic analyses, particularly those involving complex models accounting for multi-level variables. Collaborates as Director of the Comstock Center in Washington County, helping to coordinate staffing and financial support for the studies in Washington County.

Justin B. Echouffo Tcheugui, MD, PhD, MPhil
Co-Investigator
Contributes his expertise regarding the association of diabetes and glycemic measures with macrovascular outcomes. Provides expertise in biomarker research and contributes to the design and conduct of the interventional trial targeting patients with type 2 diabetes mellitus.

Patti Ephraim, MPH
Co-Investigator
Provides her experience coordinating clinical trials and multi-institutional studies. Works closely with Dr. Hill-Briggs in the adaptation of the DECIDE content and refinement of the intervention leader materials and training materials.

Gary Gerstenblith, MD, JD
Co-Investigator
Contributes his expertise in performing clinical trials targeting cardiovascular outcomes to support study aims. Participates in the planning and performance of the interventional study.

Felicia Hill-Briggs, PhD
Co-Investigator
Serves as the developer of the ADA-recognized DECIDE Self-Management Support program that will be adapted for this study. Oversees the adaptation of the DECIDE content to emphasize congestive heart failure risk and prevention. Provides guidance for the planning, development, and implementation of the DECIDE intervention throughout the study.

Lena Mathews, MD, MHS
Co-Investigator
Informs the exercise protocol, supports the supervision of CHW’s, and contributes to EMR based analyses.

Kunihiro Matsushita, MD, PhD
Co-Investigator
Contributes his experience in echo and heart failure research. Assists with the EMR-based analyses at Meritus Medical Center and Johns Hopkins Hospital.

Kerry Stewart, EdD
Co-Investigator
Contributes his expertise in exercise interventions and will develop the exercise and safety protocols for the project. Assists with adapting the components of the problem-solving intervention focused on a healthy lifestyle and exercise.

Elizabeth Vrany, PhD
Co-Investigator
Serves as a Facilitator and Master Trainer of the DECIDE program and works closely with Dr. Hill-Briggs and Ms. Ephraim in the adaptation of the DECIDE content. Trains the health educators in the delivery of the intervention and serves as a resource throughout the delivery of the intervention.