Heart Matters: a study protocol for a community based randomized trial aimed at reducing cardiovascular risk in a rural, African American community

Abstract Background African Americans living in the rural south have the highest prevalence of cardiovascular disease (CVD) risk in the United States. Given this geographic and racial disparity, intervention implementation needs to be evaluated for effectiveness and feasibility with African Americans in the rural south. Methods The trial developed out of a community-based participatory research partnership, Project GRACE, and community partners who are collaborators throughout the study. Heart Matters is a randomized stepped wedge trial that will assess the effectiveness of a 12-month behavioral change intervention adapted from PREMIER, an evidence-based treatment targeting multiple CVD risk factors. 140 participants will be recruited through 8 community- or faith-based organizations to participate in the intervention. Through matched pair randomization, organizations will be randomized to begin immediately after baseline data collection (Arm 1) or delayed 6 months (Arm 2). Data collection will occur at baseline, 6, 12, and 18 months. The primary outcome is change in body weight. In addition to assessing effectiveness, the study will also evaluate process and feasibility outcomes through quantitative and qualitative data collection. Discussion This study will contribute to CVD prevention research and likely have a positive impact on the rural, African American community where the trial occurs. Our study is unique in its use of community partnerships to develop, implement, and evaluate the intervention. We expect that this approach will enhance the feasibility of the trial, as well as future dissemination and sustainability of the intervention. Trial registration Clinical Trials, NCT02707432 . Registered 13 March 2016

Multisite Randomized Trial of a Single-Session Versus Multisession Literacy-Sensitive Self-Care Intervention for Patients With Heart Failure

Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy

Trust in Community-Engaged Research Partnerships: A Methodological Overview of Designing a Multisite Clinical and Translational Science Awards (CTSA) Initiative.

Community-engaged research (CEnR) builds on the strengths of the Clinical and Translational Science Awards (CTSA) framework to address health in underserved and minority communities. There is a paucity of studies that identify the process from which trust develops in CEnR partnerships. This study responds to the need for empirical investigation of building and maintaining trust from a multistakeholder perspective. We conducted a multi-institutional pilot study using concept mapping with to better understand how trust, a critical outcome of CEnR partnerships, can act as "social capital." Concept mapping was used to collect data from the three stakeholder groups: community, health-care, and academic research partners across three CTSAs. Concept mapping is a mixed-methods approach that allows participants to brainstorm and identify factors that contribute to a concept and describe ways in which those factors relate to each other. This study offers important insights on developing an initial set of trust measures that can be used across CTSAs to understand differences and similarities in conceptualization of trust among key stakeholder groups, track changes in public trust in research, identify both positive and negative aspects of trust, identify characteristics that maintain trust, and inform the direction for future research

Multisite Randomized Trial of a Single-Session Versus Multisession Literacy-Sensitive Self-Care Intervention for Patients With Heart Failure

BACKGROUND: Self-care training can reduce hospitalization for heart failure (HF), and more intensive intervention may benefit more vulnerable patients, including those with low literacy. METHODS AND RESULTS: A 1-year, multisite, randomized controlled comparative effectiveness trial with 605 patients with HF. Those randomized to single session received a 40-minute in-person, literacy-sensitive training; the multisession group received the same initial training and then ongoing telephone-based support. The primary outcome was combined incidence of all-cause hospitalization or death; secondary outcomes included HF-related hospitalization and HF-related quality of life (HFQOL) with pre-specified stratification by literacy. Overall, the incidence of all-cause hospitalization and death did not differ between intervention groups (incidence rate ratio (IRR)=1.01 (95% Confidence Interval (CI): 0.83, 1.22). The effect of multisession training compared with single session training differed by literacy group: among low literacy, multisession yielded lower incidence of all-cause hospitalization and death: IRR=0.75 (0.45,1.25); and among higher literacy, multisession yielded higher incidence: IRR=1.22 (0.99,1.50) (interaction p=0.048). For HF-related hospitalization: among low literacy, multisession yielded lower incidence: IRR=0.53 (95% CI: 0.25,1.12); and among higher literacy, multisession yielded higher incidence: IRR=1.32 (95% CI: 0.92,1.88) (interaction p=0.005). HFQOL improved more for patients receiving multisession compared with single session at 1 and 6 months, but the difference at 12 months was smaller. Effects on HFQOL did not differ by literacy. CONCLUSIONS: Overall, an intensive multisession intervention did not change clinical outcomes compared with a single session intervention. People with low literacy appear to benefit more from multisession than people with higher literacy. CLINICAL TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov; Identifier: NCT00378950