INCREASING ADHERENCE IN A HYPERTENSION CLINICAL TRIAL

提高高血压临床试验的依从性

• 批准号: 3554040
• 负责人: GLENYS A HAMILTON
• 金额: $ 16.28万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-08-12 至 1995-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3554040
• 关键词: antihypertensive agents; blood pressure; cardiovascular disorder chemotherapy; cardiovascular disorder education; clinical trials; cooperative study; counseling; health behavior; health care cost /financing; human subject; human therapy evaluation; hypertension; patient care management; potassium; questionnaires; telecommunications; therapy compliance; urinalysis

The primary objective of the proposed study is to assess the impact and cost effectiveness of interventions aimed at improving adherence within a clinical trial, in this case a trial of oral potassium supplement to antihypertensive therapy. From a specialty hypertension clinic at the University of Massachusetts Medical Center, 180 patients with well established drug treatment of essential hypertension will be recruited. Patients will be excluded only on the basis of renal impairment, hyperkalemia, need for potassium-sparing diuretics, other unstable concurrent disease, or reduced dietary sodium intake as determined by 24-hour urinary sodium levels below 120 mmol. In a parallel group design study, subjects will be randomly assigned to receive 60 mmol of an oral potassium preparation in three divided doses per day, or a matching placebo. Within these double-blinded treatment groups, patients will additionally be randomized to one of three adherence programs while maintaining stable antihypertensive drug treatment. The three adherence intervention programs will consist of (1) standard care, (2) telephone contact once every three weeks to encourage adherence, and (3) a 30 minute program of education and individual counseling with follow up counseling four weeks later. These patient-centered, educational/ behavioral counseling sessions will be based on knowledge of patients' health beliefs and other variables linked to likelihood of adherence, obtained from questionnaires administered at the initiation of the study. During twelve weeks, the influence of a) oral potassium upon sitting systolic and diastolic blood pressure, the adherence interventions upon serum potassium concentration, and urinary sodium and potassium excretion over 24 hours, and b) adherence interventions on specific adherence measures, will be determined. The primary method of assessing adherence will be percentage of observed medication vial openings in relation to the number anticipated, recorded using the medication event monitoring system (MEMS). An additional major adherence assessment in those patients assigned to receive oral potassium will be the extent of increase in daily urinary potassium excretion. Secondary measures of treatment adherence will include tablet counts, and patient interview. The different measures of adherence will be compared to assess which correlate with one another. The proposed project will be a collaborative effort between researchers in the Graduate School of Nursing and the Department of Medicine of the University of Massachusetts Medical Center.

拟议研究的主要目的是评估影响 以及旨在改善干预措施的成本效益 临床试验中的依从性，在本例中是口服试验 抗高血压治疗中补充钾。 来自英国大学的专业高血压诊所 马萨诸塞州医疗中心，180 名患者均已接受良好治疗 原发性高血压的药物治疗将被招募。 患者仅因肾功能损害而被排除， 高钾血症、需要保钾利尿剂、其他不稳定 并发疾病，或根据确定减少膳食钠摄入量 24 小时尿钠水平低于 120 mmol。 在平行的 小组设计研究，受试者将被随机分配接受 口服钾制剂 60 mmol，分三次服用 日，或匹配的安慰剂。 在这些双盲治疗中 组中，患者将另外被随机分配到三组之一 坚持计划，同时维持稳定的抗高血压药物 治疗。 这三个依从性干预计划将包括 (1) 标准护理，(2) 每三周一次电话联系 鼓励坚持，以及 (3) 30 分钟的教育计划 以及个人咨询和四个星期的后续咨询 之后。 这些以患者为中心的教育/行为咨询 会议将基于对患者健康信念的了解和 与遵守可能性相关的其他变量，来自 在研究开始时进行的问卷调查。 期间 十二周，a) 口服钾对坐姿的影响 收缩压和舒张压，依从性干预措施 根据血清钾浓度和尿钠浓度 24 小时内的钾排泄，以及 b) 依从性干预措施 将确定具体的遵守措施。 初级 评估依从性的方法将是观察到的百分比 药物瓶开口与预期数量的关系， 使用药物事件监测系统（MEMS）记录。 一个 对分配的患者进行额外的主要依从性评估 接受口服钾的每日摄入量会增加的程度 尿钾排泄。 次要治疗措施 依从性将包括药片计数和患者访谈。 这 将比较不同的依从性衡量标准，以评估哪些 彼此相关。 拟议的项目将是双方的合作努力 护理研究生院及护理学系的研究人员 马萨诸塞大学医学中心医学博士。