Jason A Nieuwsma1, Laura O Wray2, Corrine I Voils3, Jennifer M Gierisch3, Margaret Dundon4, Cynthia J Coffman5, George L Jackson3, Rhonda Merwin6, Christina Vair7, Karen Juntilla8, Courtney White-Clark8, Amy S Jeffreys8, Amy Harris8, Michael Owings9, Johnpatrick Marr9, David Edelman3. 1. Mid-Atlantic MIRECC, Department of Veterans Affairs, Durham, NC, United States; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States. Electronic address: jason.nieuwsma@duke.edu. 2. VA Center for Integrated Healthcare, VA Western New York Healthcare System, Buffalo, NY, United States; Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States. 3. Center for Health Services Research in Primary Care, Department of Veterans Affairs, Durham, NC, United States; Department of Medicine, Duke University Medical Center, Durham, NC, United States. 4. National Center for Health Promotion and Disease Prevention, Department of Veterans Affairs, Durham, NC, United States. 5. Center for Health Services Research in Primary Care, Department of Veterans Affairs, Durham, NC, United States; Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, United States. 6. Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, United States; Center for Health Services Research in Primary Care, Department of Veterans Affairs, Durham, NC, United States. 7. VA Center for Integrated Healthcare, VA Western New York Healthcare System, Buffalo, NY, United States. 8. Center for Health Services Research in Primary Care, Department of Veterans Affairs, Durham, NC, United States. 9. Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States.
Abstract
BACKGROUND: Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. METHODS:Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. CONCLUSION: Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01838226. Published by Elsevier Inc.
RCT Entities:
BACKGROUND: Health behaviors related to diet, tobacco usage, physical activity, medication adherence, and alcohol use are highly determinative of risk for developing cardiovascular disease. This paper describes a study protocol to evaluate a problem-solving intervention that aims to help patients at risk for developing cardiovascular disease address barriers to adopting positive health behaviors in order to reduce cardiovascular risk. METHODS: Eligible patients are adults enrolled in Veterans Affairs (VA) health care who have not experienced a cardiovascular event but are at elevated risk based on their Framingham Risk Score (FRS). Participants in this two-site study are randomized to either the intervention or care as usual, with a target of 400 participants. The study intervention, Healthy Living Problem-Solving (HELPS), consists of six group sessions conducted approximately monthly interspersed with individualized coaching calls to help participants apply problem-solving principles. The primary outcome is FRS, analyzed at the beginning and end of the study intervention (6months). Participants also complete measures of physical activity, caloric intake, self-efficacy, group cohesion, problem-solving capacities, and demographic characteristics. CONCLUSION: Results of this trial will inform behavioral interventions to change health behaviors in those at risk for cardiovascular disease and other health conditions. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01838226. Published by Elsevier Inc.
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