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

• 批准号: 7392881
• 负责人: DANIEL C. CHERKIN
• 金额: $ 23.69万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 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/7392881
• 关键词: Adherence; Age; Behavior; Blood Glucose Self-Monitoring; Blood Pressure; Body mass index; Botanicals; Caring; Characteristics; Chronic; Chronic Disease; Clinical; Communities; Computerized Medical Records Systems; Condition; Contracts; Counseling; Coupled; Data; Databases; Diabetes Mellitus; Diet; Disease; Dyslipidemias; Effectiveness; Electronics; 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; Therapeutic; Training; Triglycerides; United States; Visit; diet and exercise; dietary supplements; disorder control; improved; member; prospective; stress management; success; treatment duration

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）：糖尿病是美国医疗治疗中最紧张，最昂贵的慢性疾病之一，通常无法充分控制这种疾病，有时会导致昂贵和灾难性的后果。有效护理的一个关键但充满挑战的组成部分是激励患有糖尿病的人改变其生活方式，尤其是与饮食和体育锻炼有关的方面。自然疗法医生轶事地报告了在激励患者控制糖尿病和其他慢性病方面取得的成功，试图通过咨询健康的生活方式来对自己的健康承担责任。尽管小型回顾性研究的结果表明，自然疗法护理可以改善糖尿病的结果，但现实世界中的整体系统（非估计）自然疗法护理的潜力尚未得到预期评估。这项前瞻性观察性研究将研究具有涵盖自然疗法护理的2型糖尿病患者的辅助性自然疗法护理的影响。 21至65岁之间的综合医疗保健提供系统的所有成员，他们患有2型糖尿病，具有血红蛋白A1C（HBA1C）值在7.5％至9.5％之间，并且未使用胰岛素，并且将被识别出随机样本，并邀请随机样本并邀请参加。同意参加的前30名采访成员将为其糖尿病提供辅助性自然疗法护理。 30名同意参加的特征（例如，临床和社会人口统计学指标，自然疗法护理的知识/观点）将与衰落的人进行比较。自然疗法将采用生活方式/自我管理咨询（运动，饮食，压力管理，对血糖的自我监测）以及植物和营养补充剂的建议。一年内，将允许对健康计划合同的自然疗法医师网络中许可的自然疗法医生进行多达8次访问。有关临床结果的数据将从健康计划的高级自动病历系统中提取。在一年的治疗期内，HBA1C（主要结果）和体重指数，脂质，血压和甘油三酸酯的变化将被测量。以患者为中心的结果（例如，糖尿病的生活质量，感知的压力，饮食和运动效能感），并且将在6个月和12个月后通过电话访谈评估对治疗建议的遵守。 30名参与者的样本量将提供超过90％的功率，以检测平均HBA1C的1.0个百分点降低。这项研究设计以及有关临床结果的电子数据的可用性，将允许比较30名参与者的任何改进与对整个符合研究资格的糖尿病患者的群体的改进，从中进行了采样参与者。如果这项观察性研究的结果是有希望的，则将提出一项评估糖尿病自然疗法护理的随机对照试验。