Outcomes of Community Naturopathic Medical Care for Type 2 Diabetes

2 型糖尿病社区自然疗法医疗护理的结果

基本信息

批准号：
7599612
负责人：
DANIEL C. CHERKIN
金额：
$ 16万
依托单位：
KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-04-01 至 2011-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7599612
关键词：
21 year old Adherence Behavior Blood Glucose Self-Monitoring Blood Pressure Body mass index Botanicals Caring Characteristics Chronic Chronic Disease Clinical Communities Computerized Medical Records Systems Contracts Counseling Coupled Data Databases Diabetes Mellitus Diet Disease Dyslipidemias Effectiveness Failure Glycosylated hemoglobin A Guidelines Habits Health Health Planning Hypertension Insulin Insurance Benefits Integrated Delivery of Health Care Interview Licensing Life Life Style Lipids Measures Medical Non-Insulin-Dependent Diabetes Mellitus Obesity Observational Study Outcome Participant Patient-Focused Outcomes Patients Perceived quality of life Persons Pharmaceutical Preparations Physical activity Physicians Pilot Projects Population Prospective Studies Public Health Randomized Controlled Trials Recommendation Reporting Research Research Design Retrospective Studies Risk Sample Size Sampling Self Efficacy Self Management Stress System Telephone Interviews Training Triglycerides United States Visit diabetes control diet and exercise dietary supplements disorder control electronic data empowered improved member primary outcome prospective stress management success therapeutic lifestyle change treatment duration

项目摘要

DESCRIPTION (provided by applicant): Diabetes is one of the most consequential and expensive chronic diseases in the U.S. Medical treatments often fail to adequately control this disease, sometimes resulting in costly and catastrophic outcomes later in life. A critical, but challenging, component of effective care is motivating persons with diabetes to change their lifestyles, particularly those aspects related to diet and physical activity. Naturopathic physicians have anecdotally reported successes in motivating their patients to control diabetes and other chronic conditions by trying to empower them to take responsibility for their health through counseling about healthy lifestyles. Although results of small retrospective studies suggest naturopathic care may improve diabetes outcomes, the potential for real world whole systems (non-protocolized) naturopathic care to improve control of diabetes has yet to be prospectively evaluated. This prospective observational study will examine the effect of one year of adjunctive naturopathic care for persons with type 2 diabetes who have an insurance benefit that covers naturopathic care. All members of an integrated health care delivery system between the ages of 21 and 65, who have type 2 diabetes with hemoglobin A1c (HbA1c) values between 7.5% and 9.5% and who are not using insulin will be identified and a random sample will be interviewed and invited to participate. The first 30 interviewed members who agree to participate will receive adjunctive naturopathic medical care for their diabetes. The characteristics (e.g., clinical and sociodemographic measures, knowledge/views of naturopathic care) of the 30 who agree to participate will be compared with those who decline. Naturopathic treatment will feature lifestyle/self-management counseling (exercise, diet, stress management, self-monitoring of blood glucose) and recommendations of botanical and nutritional supplements. Up to 8 visits over a one year period to licensed naturopathic physicians in the health plan's contracted naturopathic physician network will be allowed. Data on clinical outcomes will be extracted from the health plan's advanced automated medical records systems. Changes in HbA1c (primary outcome) and in body mass index, lipids, blood pressure and triglycerides over the one year treatment period will be measured. Patient-centered outcomes (e.g., diabetes quality of life, perceived stress, diet and exercise self-efficacy), and adherence to treatment recommendations will be assessed by telephone interviews after 6 and 12 months. A sample size of 30 participants will provide over 90% power to detect a 1.0 percentage point decrease in mean HbA1c. This study design and the availability of electronic data on clinical outcomes, will allow comparison of any improvements found for the 30 participants with those occurring for the entire study-eligible population of diabetes patients from which participants were sampled. If the results of this observational study are promising, a randomized controlled trial evaluating naturopathic care for diabetes will be proposed.

描述（由申请人提供）：糖尿病是美国最严重和最昂贵的慢性疾病之一。医学治疗常常无法充分控制这种疾病，有时会在以后的生活中造成代价高昂和灾难性的结果。有效护理的一个关键但具有挑战性的组成部分是激励糖尿病患者改变他们的生活方式，特别是与饮食和身体活动相关的方面。据传闻，自然疗法医生通过提供有关健康生活方式的咨询，试图让患者对自己的健康负责，从而成功地激励患者控制糖尿病和其他慢性病。尽管小型回顾性研究的结果表明自然疗法可能会改善糖尿病的结局，但现实世界的整个系统（非方案化）自然疗法改善糖尿病控制的潜力尚未得到前瞻性评估。这项前瞻性观察性研究将探讨一年辅助自然疗法护理对于拥有自然疗法护理保险福利的 2 型糖尿病患者的影响。综合医疗保健服务系统中年龄在 21 岁至 65 岁之间、患有 2 型糖尿病、糖化血红蛋白 (HbA1c) 值在 7.5% 至 9.5% 之间且未使用胰岛素的所有成员将被识别，并随机抽取样本接受采访并受邀参加。同意参加的前 30 名接受采访的会员将接受针对糖尿病的辅助自然疗法医疗护理。同意参与的 30 名参与者的特征（例如，临床和社会人口统计学指标、自然疗法护理知识/观点）将与拒绝参与的人进行比较。自然疗法将以生活方式/自我管理咨询（运动、饮食、压力管理、血糖自我监测）以及植物和营养补充剂的建议为特色。一年内允许最多 8 次就诊健康计划签约自然疗法医师网络中的持照自然疗法医师。临床结果数据将从健康计划的先进自动化医疗记录系统中提取。将测量一年治疗期间 HbA1c（主要结果）以及体重指数、血脂、血压和甘油三酯的变化。以患者为中心的结果（例如，糖尿病生活质量、感知压力、饮食和运动自我效能）以及对治疗建议的遵守情况将在 6 个月和 12 个月后通过电话访谈进行评估。 30 名参与者的样本量将提供超过 90% 的功效来检测平均 HbA1c 下降 1.0 个百分点。这项研究设计和临床结果电子数据的可用性，将允许将 30 名参与者发现的任何改善与从参与者中抽取样本的整个研究资格糖尿病患者群体中发生的改善进行比较。如果这项观察性研究的结果有希望，将提出一项评估自然疗法治疗糖尿病的随机对照试验。