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一项降低退伍军人心血管疾病风险的问题解决干预措施:一项随机对照试验的方案

A problem-solving intervention for cardiovascular disease risk reduction in veterans: Protocol for a randomized controlled trial.

作者信息

Nieuwsma Jason A, Wray Laura O, Voils Corrine I, Gierisch Jennifer M, Dundon Margaret, Coffman Cynthia J, Jackson George L, Merwin Rhonda, Vair Christina, Juntilla Karen, White-Clark Courtney, Jeffreys Amy S, Harris Amy, Owings Michael, Marr Johnpatrick, Edelman David

机构信息

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.

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.

出版信息

Contemp Clin Trials. 2017 Sep;60:42-50. doi: 10.1016/j.cct.2017.06.001. Epub 2017 Jun 23.

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.

摘要

背景

与饮食、烟草使用、身体活动、药物依从性及酒精使用相关的健康行为在很大程度上决定了患心血管疾病的风险。本文描述了一项研究方案,旨在评估一种解决问题的干预措施,该措施旨在帮助有患心血管疾病风险的患者克服在采取积极健康行为方面的障碍,以降低心血管风险。

方法

符合条件的患者为参加退伍军人事务部(VA)医疗保健的成年人,他们未曾经历过心血管事件,但根据弗雷明汉风险评分(FRS)处于高危状态。这项双地点研究的参与者被随机分为干预组或常规护理组,目标是招募400名参与者。研究干预措施“健康生活问题解决法”(HELPS)包括大约每月进行一次的六次小组会议,并穿插个性化辅导电话,以帮助参与者应用解决问题的原则。主要结局指标是FRS,在研究干预开始和结束时(6个月)进行分析。参与者还需完成身体活动、热量摄入、自我效能感、群体凝聚力、解决问题能力及人口统计学特征的测量。

结论

该试验结果将为改变心血管疾病及其他健康状况高危人群健康行为的行为干预提供参考。

试验注册

ClinicalTrials.gov标识符NCT01838226。

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