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 旨在改善干预措施的成本效益 在临床试验中依从性，在这种情况下是口服试验 降压治疗钾补充剂。 从大学的专业高血压诊所 马萨诸塞州医疗中心，有180名成熟的患者 将招募必要高血压的药物治疗。 仅根据肾功能障碍将患者排除在外， 高钾血症，需要钾的利尿剂，其他不稳定 同时疾病或降低饮食钠的摄入量 低于120 mmol的24小时尿钠水平。 平行 小组设计研究，受试者将被随机分配接受 60 mmol的口服钾制剂，分为三个分剂量 一天，或匹配的安慰剂。 在这些双盲治疗中 组，患者还将随机分为三个 依从性计划，同时保持稳定的降压药 治疗。 三个依从性干预计划将组成 （1）标准护理，（2）一次电话联系一次 鼓励依从性和（3）30分钟的教育计划 和个人咨询以及后续咨询四个星期 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知识和 与依从性相关的其他变量，从 在研究开始时进行了调查表。 期间 十二周，a）口腔钾的影响 收缩和舒张压，粘附干预措施 血清钾浓度和尿钠和 24小时以上的钾排泄，b）依从性干预措施 根据具体的依从性措施，将确定。 主要 评估依从性的方法将为观察到的百分比 与预期的数字有关的药物瓶开口 使用用药事件监控系统（MEMS）记录。 一个 分配的患者的其他重大依从性评估 接受口服钾将是每天增加的程度 尿钾排泄。 次要治疗方法 依从性将包括平板电脑计数和患者面试。 这 将比较不同的依从性措施 彼此相关。 拟议的项目将是一项合作的努力 护理研究生院的研究人员 马萨诸塞大学医学中心的医学。