The Role of Apathy in Glycemic Control

冷漠在血糖控制中的作用

• 批准号: 7687317
• 负责人: Cyrus V Desouza
• 金额: --
• 依托单位: OMAHA VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7687317
• 关键词: Adherence; Aging; Behavior; Blood Vessels; Clinic; Comorbidity; Complex; Complications of Diabetes Mellitus; Diabetes Mellitus; Diabetic Angiopathies; Dose; Double-Blind Method; Effectiveness; Equipment and supply inventories; Evaluation; General Population; Glycosylated hemoglobin A; Goals; Health system; Healthcare; Incidence; Insulin Resistance; Intake; Intervention; Lead; Life Style; Measures; Medical; Methods; Methylphenidate; Morbidity - disease rate; Motivation; Obesity; Outcome; Outcome Measure; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Placebos; Population; Prevalence; Primary Health Care; Problem behavior; Public Health; Randomized; Recommendation; Regimen; Relative (related person); Research; Research Design; Risk; Role; Self Care; Staging; System; Testing; Treatment Protocols; Veterans; Weight; cardiovascular risk factor; clinically significant; compliance behavior; design; diabetes control; diabetes management; diet and exercise; functional status; glycemic control; health administration; improved; macrovascular disease; mortality; placebo controlled study; primary outcome; prospective; public health relevance; secondary outcome; tool

DESCRIPTION (provided by applicant): The prevalence of diabetes among veterans in the VA health system is more than 20% and is double that of the general population. Patients with diabetes are at increased risk for macro and micro vascular complications which are dependant on glycemic control. Control of diabetes depends to a large extent on patient self care behaviors. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs self-care behavior in diabetes patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for diabetes. Lack of motivation might decrease a patient's ability to initiate exercise, diet and other lifestyle changes, whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. Apathy could also influence patient compliance to diabetes medications. Together this could result in poor control of diabetes and increased complications. Treating apathy might therefore improve adherence to medical regimens and self care behaviors resulting in better diabetes outcomes Hypothesis:Our hypothesis is that pharmacological treatment of apathy will improve glycemic control for patients with poorly controlled diabetes. Specific Aim 1: Evaluate if methylphenidate treatment of apathy improves glycemic control in patients with poorly controlled diabetes. Specific Aim 2: Determine if methylphenidate improves patient motivation and adherence to diabetes self-care behavior. Project Design and Methods: Study Design: This is a prospective randomized double blind placebo-controlled study. Study duration will be 6 months. Patients with poorly controlled diabetes (A1c>8) and clinically significant apathy (AES >30) will be randomized to either treatment with methylphenidate or placebo. Details of dosing strength and duration are given in the proposal. The primary outcome measure will be change in HbA1c. Secondary outcome measures include those in specific Aim 2 and are PAM, sub-domains of AES and SCI. Potential Impact on Veterans health care: About 20% of veterans have diabetes. Complications of diabetes increase mortality and morbidity greatly. Apathy is very prevalent in the veteran population. Apathy may lead to decreased compliance to medication and impair self care behaviors. Treating apathy may therefore improve motivation and persistence thereby improving compliance and self care behavior. This would lead to better outcomes in diabetes patients in the VA. PUBLIC HEALTH RELEVANCE: Narrative-Significance of the proposed research; Over 20% of veteran patients have diabetes. The incidence of diabetes is expected to increase at an alarming rate over the next decade, in tandem with the increase in the incidence of obesity and the relative aging of the population. Patients with diabetes have a 2-4 fold risk of cardiovascular complications when compared to patients without diabetes. In spite of considerable advances in diabetes management, less than 10% of patients are at goal. Factors that effect adequate implementation of diabetes management regimens need to be studied. Apathy may be one of these factors since apathy leads to a loss of motivation and persistence. Treating apathy may lead to increased adherence to management regimens thus leading to better outcomes in diabetes.

描述（由申请人提供）： 退伍军人事务部卫生系统退伍军人中糖尿病患病率超过 20%，是普通人群的两倍。糖尿病患者发生大血管和微血管并发症的风险增加，这取决于血糖控制。糖尿病的控制在很大程度上取决于患者的自我护理行为。冷漠是一种常见的行为问题，其特征是丧失主动性、动力不足和坚持不懈。冷漠的存在会损害糖尿病患者的自我护理行为。缺乏新颖性可能会损害患者寻求新的互动、生活方式和新的糖尿病治疗方案的能力。缺乏动力可能会降低患者开始锻炼、饮食和其他生活方式改变的能力，而缺乏毅力则会损害对这些治疗方案的依从性。因此，冷漠影响自我保健的各个阶段。冷漠还可能影响患者对糖尿病药物的依从性。总之，这可能导致糖尿病控制不佳并增加并发症。因此，治疗冷漠可能会提高对医疗方案和自我保健行为的依从性，从而导致更好的糖尿病结局。 假设：我们的假设是，冷漠的药物治疗将改善糖尿病控制不佳患者的血糖控制。具体目标 1：评估哌甲酯治疗冷漠是否可以改善糖尿病控制不佳的患者的血糖控制。具体目标 2：确定哌醋甲酯是否可以提高患者的积极性和糖尿病自我护理行为的依从性。 项目设计和方法： 研究设计：这是一项前瞻性随机双盲安慰剂对照研究。学习期限为6个月。糖尿病控制不佳 (A1c>8) 和临床显着冷漠 (AES >30) 的患者将被随机分配接受哌醋甲酯或安慰剂治疗。提案中给出了给药强度和持续时间的详细信息。主要结果指标是 HbA1c 的变化。次要结果指标包括具体目标 2 中的指标，并且是 PAM、AES 和 SCI 的子域。 对退伍军人医疗保健的潜在影响：约 20% 的退伍军人患有糖尿病。糖尿病并发症大大增加死亡率和发病率。冷漠在退伍军人群体中非常普遍。冷漠可能会导致药物依从性下降并损害自我护理行为。因此，治疗冷漠可以提高动机和毅力，从而提高依从性和自我保健行为。这将为退伍军人管理局的糖尿病患者带来更好的结果。 公共卫生相关性： 叙述-拟议研究的意义；超过20%的退伍军人患者患有糖尿病。随着肥胖发病率的增加和人口的相对老龄化，预计未来十年糖尿病的发病率将以惊人的速度增加。与非糖尿病患者相比，糖尿病患者发生心血管并发症的风险是非糖尿病患者的 2-4 倍。尽管糖尿病管理取得了相当大的进步，但只有不到 10% 的患者达到了目标。需要研究影响充分实施糖尿病管理方案的因素。冷漠可能是这些因素之一，因为冷漠会导致动力和毅力的丧失。治疗冷漠可能会增加对治疗方案的依从性，从而带来更好的糖尿病治疗结果。