Translating Unique Learning for Incontinence Prevention: The TULIP Project

将独特的学习成果转化为预防失禁：TULIP 项目

• 批准号: 7862867
• 负责人: CAROLYN M SAMPSELLE
• 金额: $ 61.29万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-28 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7862867
• 关键词: Adherence; Adopted; Adoption; Adult; Age; Behavioral; Bladder; Breast; Caring; Cervical; Clinic Visits; Consultations; Cost Analysis; Cost Effectiveness Analysis; Data; Distress; Economics; Education; Educational process of instructing; Effectiveness; Elements; Employment; Financial cost; Foundations; Frequencies; Future; Health; Hour; Incidence; Incontinence; Individual; International; Internet; Intervention; Interview; Knowledge; Learning; Malignant neoplasm of ovary; Measures; Michigan; Modeling; Online Systems; Outcome; Pelvic Floor Muscle; Pennsylvania; Pharmacotherapy; Population; Prejudice; Prevention; Prevention program; Prevention strategy; Preventive; Preventive Intervention; Productivity; Quality of life; Randomized; Randomized Clinical Trials; Research; Risk; Science; Self Efficacy; Self Management; Services; Severities; Site; Stress; Stress Urinary Incontinence; Symptoms; Testing; Time; Training; Translating; Translations; United States; United States National Institutes of Health; Urinary Incontinence; Visit; Wing; Woman; aged; arm; base; comparative effectiveness; cost; cost effectiveness; effectiveness trial; follow-up; group intervention; heme oxygenase-1; innovation; insight; novel; post intervention; prevent; primary outcome; programs; public health relevance; symposium; willingness to pay

DESCRIPTION (provided by applicant): More than one in three US women suffer from the distressing, embarrassing, and often unreported problem of urinary incontinence (UI). A key committee of the 2008 International Consultation on Incontinence concluded that pelvic floor muscle training (PFMT) should be offered as first line therapy to all women with stress, urge, or mixed UI and that bladder training (BT) may be preferred to drug therapy. Conservative strategies are low risk and do not prejudice future treatments. We reasoned that such self-management practices should also prevent UI and conducted a RCT to test a prevention behavioral program. A group session presented an array of conservative self-management practices- PFMT, BT and the Knack Maneuver, which is a preemptive contraction to decrease stress UI and/or suppress urge UI. At 12-months post- intervention we found a two-fold UI prevention effect. Moreover, we found high and sustained adherence: 82% at 3 months post intervention and 68% at 12 months. At four years follow-up, sustained adherence of 70% was predicted by early self-efficacy. This intervention is novel because it enables women to adopt and sustain efficacious bladder health practices for incontinence prevention, whereas to date conservative management approaches have focused on treatment. Based on what we now know, these practices should be part of standard well woman care, but it is not realistic to expect busy clinicians to provide this information within the confines of a brief encounter. We have developed a 15-minute DVD that is a condensed version of the prevention behavioral session; it is culturally sensitive and has yielded comparable levels of knowledge and self-efficacy. Using two sites (Michigan and Pennsylvania), we aim to compare the outcomes of the group behavioral program to the DVD version by randomizing 600 women aged 55 years and older to two arms of a comparative effectiveness trial. Follow-up will be at 3-months, 12-months, and 24-months post-intervention. (Aim 1). Controlling for age and BMI, we will test the hypotheses: HO1: There will be no difference in UI incidence demonstrated between groups (PRIMARY HO) HO2: There will be no difference in post-intervention self-management adherence between groups HO3: There will be no difference in post-intervention self-efficacy to adopt strategies between groups We will conduct an economic analysis comparing the two-hour session with the DVD version (Aim 2). Describing the costs and analyzing the willingness to pay and employment data will be the primary focus of this study in order to create the foundation for a future cost-effectiveness analysis, should trial hypotheses be confirmed. At 36-months post-intervention, we will conduct interviews to learn which intervention elements contributed to sustainability of adherence (Aim 3). Our long-range objective is to provide a UI prevention intervention suitable for wide-spread translation at the point of well woman care (annual visit). PUBLIC HEALTH RELEVANCE: More than one of every three women in the United States suffers from the distressing and hidden problem of urinary incontinence, a condition that costs our economy more than $19 billion per year (greater than the combined costs of breast, cervical, and ovarian cancers). Our innovative prevention program teaches women about low-risk, self-management practices and has been shown to cut their risk of urinary incontinence in half. If, as a result of this study, the DVD version yields similar health outcomes for less cost, it would be suitable to give to women at their annual health visits or via the internet with a benefit for untold numbers of women.

描述（由申请人提供）：超过三分之一的美国妇女遭受令人痛苦，尴尬且常常未报告的尿失禁问题（UI）。 2008年关于失禁的国际咨询的关键委员会得出的结论是，应将骨盆底肌肉训练（PFMT）作为第一线治疗，向所有有压力，敦促或混合UI的妇女进行第一线治疗，而膀胱训练（BT）可能是药物治疗的优选。保守的策略是低风险，不影响未来的治疗。我们认为，这种自我管理实践也应防止UI并进行RCT来测试预防行为计划。小组会议提出了一系列保守的自我管理实践-PFMT，BT和The Knack Mainuver，这是减轻压力UI和/或抑制URIS敦促UI的预先收缩。在干预后12个月时，我们发现了两倍的UI预防效果。此外，我们发现干预后3个月时3个月时持续高和持续的依从性，在12个月时为68％。在四年的随访中，早期自我效能感预测持续的依从性为70％。这种干预是新颖的，因为它使妇女能够采用并维持有效的膀胱健康实践来预防失禁，而迄今为止，保守的管理方法集中在治疗上。根据我们现在所知道的，这些做法应该是标准井女性护理的一部分，但是期望忙碌的临床医生在短暂相遇的范围内提供此信息是不现实的。我们已经开发了15分钟的DVD，这是预防行为会议的凝结版本。它具有文化敏感，并产生了可比的知识和自我效能水平。使用两个地点（密歇根州和宾夕法尼亚州），我们旨在通过将55岁及55岁以上的600名妇女与比较有效性试验的两个臂那样，将小组行为计划的结果与DVD版本进行比较。随访时间为3个月，12个月和24个月的干预后。 （目标1）。控制年龄和BMI，我们将测试假设：HO1：组之间的UI发病率没有差异（主要HO）HO2：HO3组之间的干预后自我管理依从性没有差异。如果确认试验假设，描述成本并分析付款和就业数据的意愿将是本研究的主要重点，以为未来的成本效益分析奠定基础。干预后36个月，我们将进行访谈，以了解哪些干预因素有助于依从性的可持续性（AIM 3）。我们的远程目标是提供适用于井女性护理时广泛翻译的UI预防干预措施（年度访问）。 公共卫生相关性：美国每三名妇女中的每三个以上都遭受了令人痛苦和隐藏的尿失禁问题，这种疾病使我们的经济每年损失超过190亿美元（大于乳房，宫颈和卵巢癌的总成本）。我们的创新预防计划向女性传授了低风险，自我管理实践的知识，并已被证明将其尿失禁的风险降低了一半。如果由于这项研究，DVD版本以较低的成本产生类似的健康结果，则适合在每年的健康访问或通过互联网上给予女性，从而对无数妇女的妇女受益。