Effect of a Pain Protocol on Discomfort in Dementia

疼痛方案对痴呆症不适的影响

• 批准号: 6744143
• 负责人: CHRISTINE R KOVACH
• 金额: $ 37.7万
• 依托单位: UNIVERSITY OF WISCONSIN MILWAUKEE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-01 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6744143
• 关键词: analgesia; analgesics; behavioral /social science research tag; clinical research; clinical trials; cognition; cognitive behavior therapy; dementia; functional ability; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; medical rehabilitation related tag; method development; nurse performance; nursing intervention; outcomes research; pain; paralinguistic behavior; patient oriented research; verbal behavior

DESCRIPTION: (provided by applicant) People should not be left in pain. The overall intent of this study is to improve assessment and treatment of physical and affective pain in people with dementia. The Assessment of Discomfort in Dementia (ADD) Protocol has been developed to assist in the differential diagnosis and treatment process. A dualistic perspective in which physical and affective needs are considered in tandem is an essential feature of the ADD Protocol and, uniquely, analgesics are used as a part of the assessment process. Testing of the ADD Protocol in two pilot studies yielded significantly decreased discomfort and increased use of analgesics and non-pharmacological comfort interventions following use of the ADD Protocol. Discomfort, scope of assessment, scope and serial trialling (defined as persistence to intervene) of interventions will be compared in two groups of people with dementia (group I: ADD Protocol; group II: standard care). A pretest posttest experimental design with blinding of subjects and data collectors will be used. Eight long-term care facilities stratified based on size and location will be randomly assigned to the treatment or control conditions. A sample of 189 subjects with a Mini Mental State Exam Score of 15 or below, Functional Assessment Stage (FAST) score of 6 or 7, who are at least 4 weeks post-admission will be included in the study. Use of the ADD Protocol will be initiated when a subject exhibits behavioral/verbal symptoms of possible discomfort that are not ameliorated by basic care interventions implemented by a nursing assistant. Process variables that will be measured and compared are: scope of assessment, scope of pharmacological and non-pharmacological interventions, and serial trials of interventions. The outcome variable is discomfort and will be assessed using the Discomfort-DAT and BEHAVE-AD tools. Inferential analysis planned includes use of multivariate analysis of variance. Several subquestions and interaction variables will also be measured. Whether differences in discomfort between the experimental and control group are dependent on dementia functional stage or the presence of verbal symptoms will be examined. Physical activity, functional status, and use of pharmacological and non-pharmacological interventions will be described.

描述：（由申请人提供）不应让人们痛苦。这项研究的总体目的是改善痴呆症患者的身体和情感疼痛的评估和治疗。已经制定了痴呆症（ADD）方案不适的评估，以帮助进行鉴别诊断和治疗过程。二元论的观点是，在串联中考虑物理和情感需求是添加方案的重要特征，并且独特地将镇痛药用作评估过程的一部分。在两项试点研究中对添加方案的测试产生了明显减少的不适感，并在使用添加方案后增加了对镇痛药和非药物舒适干预措施的使用。 在两组痴呆症患者中，将比较不适，评估范围，评估范围和串行试验（定义为持续进行干预）（I组：ADD方案； II组：标准护理）。将使用对受试者和数据收集器蒙蔽的预测试后测试实验设计。根据大小和位置进行分层的八个长期护理设施将随机分配给治疗或控制条件。该研究将包括189名精神状态考试评分15或以下的受试者，功能评估阶段（快速）分数为6或7，至少在入学后4周的样本将包括在研究中。当受试者表现出可能不适的行为/言语症状时，将启动添加方案的使用，而护理助理实施的基本护理干预措施不会改善。将测量和比较的过程变量是：评估范围，药理学和非药理学干预措施以及干预措施的串行试验。结果变量是不适的，将使用不适-DAT和BEHAD AD工具进行评估。推论分析计划包括使用多元方差分析。还将测量几个子问题和交互变量。实验组和对照组之间的不适感差异是否取决于痴呆症功能阶段或将检查言语症状的存在。将描述体育活动，功能状况以及药理和非药物干预措施的使用。