Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

小组学习减少了下尿路症状的发生率

• 批准号: 8723041
• 负责人: KATHRYN Larsen BURGIO
• 金额: $ 132.87万
• 依托单位: WILLIAM BEAUMONT HOSPITAL RESEARCH INST
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8723041
• 关键词: Address; Award; Behavior Therapy; Bladder; Client satisfaction; Clinical effectiveness; Consultations; Data; Data Coordinating Center; Economic Burden; Effectiveness; Evaluation; Frequencies; Grant; Guidelines; Health; Health Personnel; Healthcare Systems; Hour; Human; Incontinence; Individual; Instruction; International; Intervention; Learning; Living Costs; Measures; Medical; Modality; Modeling; Muscle Contraction; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Pelvic Floor Muscle; Perception; Pilot Projects; Population; Quality of life; Questionnaires; Randomized; Randomized Controlled Trials; Recruitment Activity; Research; Research Personnel; Savings; Schedule; Self Management; Severities; Site; Stress; Stress Urinary Incontinence; Symptoms; Testing; Therapeutic; Time; Training; Urinary Incontinence; Urine; Visit; Woman; arm; base; care delivery; clinical research site; community setting; compare effectiveness; cost; cost effective; cost effectiveness; economic cost; evidence based guidelines; health care cost/financing; interest; micturition urgency; muscle strength; novel; older women; prevent; primary outcome; secondary outcome; social; treatment program; urinary

DESCRIPTION (provided by applicant): Urinary Incontinence (UI) is a prevalent condition that diminishes quality of life in older women at tremendous social and economic costs. Although there are several therapeutic options available, behavioral treatments are recommended by most evidence-based guidelines as an initial approach to treatment for stress, urgency, and mixed UI. Behavioral treatments are usually delivered in individualized visits in medical offices, but a group session model of care delivery has been shown to be effective. Based on promising outcomes in our pilot studies using a novel group treatment approach, we were awarded a planning grant to assemble an interdisciplinary team of experts and develop a multi-center randomized controlled trial (RCT). The proposed study is a three-site RCT to compare the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed UI will be recruited and screened centrally, evaluated clinically at each of three study sites, and randomly assigned to one of two treatment arms: 1) Group behavioral treatment (GBT) or 2) No treatment. Outcomes will be assessed at 3-, 6-, 9-, and 12-months post-randomization. The primary outcome will be self- reported UI severity as measured by the International Consultation on Incontinence Questionnaire-UI Short Form (ICI-Q), a validated measure for research and practice. Secondary outcome measures will assess frequency of incontinence episodes, volume of urine loss, type of incontinence, pelvic floor muscle strength, patient satisfaction, patient perception of improvement, impact on quality of life, and cost-effectiveness. Once standardized with data to support its clinical effectiveness and cost-effectiveness, group treatment modalities have potential to reach a larger population of older women with UI, not only in traditional medical settings, but also in community settings, significantly reducing the human and economic burden of UI on patients, health care providers, and the health care system as a whole. PHS 398/2590 (Rev. 06/09) Page Continuation Format Page

描述（由申请人提供）：尿路感染（UI）是一种普遍存在的疾病，会降低老年妇女的生活质量，造成巨大的社会和经济代价。虽然有几种治疗方法可供选择，但大多数循证指南建议将行为治疗作为治疗压力，紧迫性和混合UI的初始方法。行为治疗通常在医疗办公室的个性化访问中提供，但小组会议模式的护理提供已被证明是有效的。基于我们使用新型分组治疗方法进行的试点研究的良好结果，我们获得了一笔计划拨款，以组建一个跨学科专家团队并开发一项多中心随机对照试验（RCT）。这项拟议的研究是一项三个地点的随机对照试验，目的是比较团体管理的行为治疗计划与不治疗的有效性和成本效益。将招募有压力、紧迫感或混合UI的女性并集中筛选，在三个研究中心的每一个进行临床评价，并随机分配到两个治疗组之一：1）团体行为治疗（GBT）或2）无治疗。将在随机化后3、6、9和12个月评估结局。主要结局将是自我报告的UI严重程度，由国际咨询委员会-UI简表（ICI-Q）测量，这是一种经验证的研究和实践测量方法。次要结局指标将评估尿失禁发作频率、尿量损失、尿失禁类型、骨盆底肌力、患者满意度、患者对改善的感知、对生活质量的影响和成本效益。一旦标准化的数据，以支持其临床效果和成本效益，组治疗模式有可能达到更大的人口与UI的老年妇女，不仅在传统的医疗环境中，而且在社区环境中，显着减少UI对患者的人力和经济负担，医疗保健提供者，和整个医疗保健系统。PHS 398/2590（Rev.06/09）