RCT on comanagement of obesity, depression, and elevated CVD risk in primary care

关于初级保健中肥胖、抑郁和心血管疾病风险升高共同管理的随机对照试验

基本信息

批准号：
8843031
负责人：
Jun Ma
金额：
$ 72.16万
依托单位：
PALO ALTO MEDICAL FOUNDATION RES INST
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-05-01 至 2019-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8843031
关键词：
18 year old Address Adoption Adult Affect Aftercare Antidepressive Agents Behavior Therapy Behavioral Body Weight decreased Body mass index Cardiovascular Diseases Caring Chronic Clinic Clinical Clinical effectiveness Combined Modality Therapy Communities Comorbidity Complement Consent Consult Consultations Cost Effectiveness Analysis Cost Savings Data Depressed mood Diabetes Mellitus Diet Disease remission Dose Early-life trauma Effectiveness Effectiveness of Interventions Electronic Mail Equilibrium Evaluation Feedback Glucose Goals Group Homes Group Practice Health Health system Heart Diseases Home environment Hybrids Hyperphagia Individual Internet Intervention Intervention Studies Interview Lead Life Style Lipids Maintenance Mediating Mediator of activation protein Medical Mental Depression Metabolic syndrome Methods Modeling Non-Insulin-Dependent Diabetes Mellitus Obesity Office Visits Outcome Participant Patient Participation Rates Patient-Centered Care Patients Perception Pharmaceutical Preparations Physical activity Policy Maker Practice Guidelines Prevalence Primary Health Care Primary Prevention Process Protocols documentation Provider Psychiatrist Public Health Quality-Adjusted Life Years Questionnaires Randomized Recommendation Recording of previous events Recruitment Activity Research Risk Factors Secure Shapes Stress Structure Supervision Surveys Symptoms Target Populations Technology Telephone Testing Time Training Translating Use Effectiveness Woman Work base behavior change cardiometabolic risk cardiovascular disorder risk care delivery clinically significant computerized data processing cost cost effectiveness depressed patient depressive symptoms design diabetes prevention program effective therapy evidence base follow-up group intervention health information technology health related quality of life health training high risk improved innovation intervention effect lifestyle intervention lifetime risk men novel obesity management patient population primary care setting problem solving therapy programs provider intervention response routine practice sex treatment as usual

项目摘要

DESCRIPTION (provided by applicant): Patients with coexisting obesity and depression and common cardiometabolic risk factors are a critical target group for primary prevention because of their increasing prevalence and increased, but potentially reversible, lifetime risk for diabete mellitus (DM) and cardiovascular disease. But little is known about how to treat them in concert in ways that are evidence-based and practical in primary care settings. The proposed study will test, for the first time, a clinical intervention that uniquely integrates the Group Lifestyle Balace (GLB) program for weight loss, which is a "real-world" translated model of the Diabetes Prevention Program lifestyle intervention, with the PEARLS collaborative stepped care program for depression, which uses problem-solving therapy (PST) as first-line with as-needed intensification through stepwise increases in doses and number of antidepressant medications. Obese, depressed adults with coexisting metabolic syndrome, pre- DM, and/or history of gestational DM will be the target patient population. Eligible and consenting primary care patients (n=404) from a large, community-based, multispecialty group practice will be randomized to receive the combined treatment or usual care for 12 months. Trained health coaches, working under co-located psychiatric and medical supervision, will provide 8 1-on-1 PST sessions over 5 months followed by 6 monthly calls. At the 4th 1-on-1 session, the coach will introduce the take-home GLB DVD, which has 12 weekly sessions and is supplemented by ongoing Web-, mobile- and email-mediated coach support for weight loss and behavior change. Following a stepped-care protocol, the supervising psychiatrist will recommend initiating or adjusting anti- depressant medications to primary providers of patients with unremitting symptoms, and if necessary, provide phone consultations to patients. Follow-up assessments will occur at 6, 12, 18, and 24 months. The primary aim is to determine the effectiveness of the intervention ("E" in the RE-AIM model). We hypothesize (1) that compared with controls, intervention participants will have better co-primary endpoints, i.e., lower mean BMI and score on the 20-item Depression Symptom Checklist at 12 months (end of treatment); (2) that these incremental intervention benefits will persist through 24 months (end of follow-up); and (3) that the intervention will show cost-effectiveness within 2 years and over a projected longer term, based on the ratio of incremental costs (estimated from health system and societal perspectives) to incremental benefits (expressed as quality-adjusted life years gained). The secondary aim is to conduct process evaluation with mixed methods for the other RE-AIM attributes: Reach (e.g., participation rate of the target population), Adoption (e.g., characteristcs of participating clinics and providers), Implementation (e.g., fidelity of intervention delivery), nd Maintenance (e.g., stakeholders' perceptions of intervention sustainability). We will also explore effect modifiers and mediators to enable intervention refinement for maximum impact. The proposed integrated multicondition approach to treating obesity and depression and cardiometabolic risk factors in primary care is novel and likely scalable, with high public health impact potential.

描述（由申请人提供）：肥胖和抑郁症共存的患者以及常见的心脏代谢危险因素是一级预防的关键目标，因为他们的患病率增加，但可能可逆的糖尿病梅洛氏菌（DM）和心血管疾病的终生风险可能性增加。但是，对于如何以循证态度和在初级保健环境中实用的方式对待他们，知之甚少。 The proposed study will test, for the first time, a clinical intervention that uniquely integrates the Group Lifestyle Balace (GLB) program for weight loss, which is a "real-world" translated model of the Diabetes Prevention Program lifestyle intervention, with the PEARLS collaborative stepped care program for depression, which uses problem-solving therapy (PST) as first-line with as-needed intensification through stepwise increases in doses and number of抗抑郁药。肥胖，抑郁的成年人患有代谢综合征，前DM和/或妊娠DM病史将是目标患者人群。来自大型的，基于社区的多专科群体实践的符合条件和同意的初级保健患者（n = 404）将被随机分配，以接受12个月的合并治疗或通常的护理。受过培训的健康教练在共同设立的精神病和医疗监督下工作，将在5个月内提供81对1的PST会议，然后每月6个电话。在第4个1对1的会议上，教练将介绍带回家的GLB DVD，该DVD每周12个会议，并通过正在进行的网络，移动和电子邮件介导的教练支持减肥和行为改变。遵循阶梯护理方案，监督精神科医生将建议向患有不易症状的患者的主要提供者发起或调整抗抑郁药，并在必要时向患者提供电话咨询。随访评估将在6、12、18和24个月进行。主要目的是确定干预措施的有效性（RE-AIM模型中的“ E”）。我们假设（1）与对照组相比，干预参与者将具有更好的共同主要终点，即平均BMI较低，并在12个月的20个项目抑郁症状清单上（治疗终止）在20个项目抑郁症状清单上得分；（2）这些增量干预益处将在24个月（随访结束）中持续存在；（3）根据增量成本（从卫生系统和社会角度估算）与增量福利（以质量调整后的寿命表示），这将在2年内和预计长期内显示成本效益。次要目的是用其他RE-AIM属性的混合方法进行过程评估：触及（例如，目标人群的参与率），采用（例如，参与诊所和提供者的特征），实施（例如，干预交付的忠诚度），ND维护（例如，利益率维持率）。我们还将探索效应修饰符和介体以实现干预改进，以获得最大的影响。拟议的综合多条件方法用于治疗肥胖和抑郁症以及在初级保健中的心脏代谢危险因素是新颖的，并且可能可扩展，并且具有很高的公共卫生影响潜力。