Conservative Treatment of Fecal Incontinence in the Elderly: Effectiveness T

描述（由申请人提供）：大便失禁（FI）影响9%的美国成年人，2.7%的成年人每周或更频繁发生。患病率随着年龄的增长而增加，到70岁时达到15%。FI对生活质量有毁灭性的影响，当患者有合并症需要护理人员的帮助时，FI大大增加了护理人员的负担。我们提出了一项有效性试验，其总体目标是确定在单点研究中显示有效的保守干预措施在由家庭保健护士传播到居家人群时是否能保持其有效性。治疗包括对患者进行关于如何维持尿失禁的生理学教育，骨盆底锻炼，预防FI的行为策略，以及使用纤维或非处方药治疗腹泻或便秘。为了在向一大群提供者传播治疗时尽量减少偏差，患者教育和治疗的其他基本组成部分包含在DVD中；然而，护士监督个体化治疗仍然很重要。该研究将在北卡罗来纳州中部的8个县进行，这些县由北卡罗来纳大学家庭保健和雷克斯家庭保健机构（本研究的合作伙伴）提供服务。这些县将被随机分为两组，城市居民和农村居民大致匹配。在前两年，一组县的所有患者将接受积极干预，而其他县的居民则接受常规护理加上DVD和症状监测以控制预期。两年后，所有8个县的患者都将接受积极干预。在排除严重认知障碍患者和有造口的患者后，我们估计252 - 340例50岁以上的FI患者将接受治疗（至少189例积极治疗，63例对照组）。具体目标是(1)表明积极治疗在改善FI严重程度、患者生活质量和护理人员负担方面比对照治疗更有效，并且改善至少维持6个月；(2)确定治疗效果的调节因子（候选变量为认知状态、行动障碍、家庭照顾者协助治疗的意愿、焦虑、抑郁、年龄和种族）；(3)探讨FI的成功治疗是否会降低疗养院转诊的风险。这是修改后的申请。

DESCRIPTION (provided by applicant): Fecal incontinence (FI) affects 9% of U.S. adults and occurs weekly or more often in 2.7%. Prevalence increases with age reaching 15% by 70 years. FI has a devastating impact on quality of life and substantially increases caregiver burden when patients have comorbid conditions requiring caregiver assistance. We propose an effectiveness trial whose overall goal is to determine whether a conservative intervention which has been shown to be effective in single-site studies will sustain its efficacy when disseminated to a home bound population by home health care nurses. The treatment includes patient education about the physiology of how continence is maintained, pelvic floor exercises, behavioral strategies for preventing FI, and use of fiber or nonprescription medication to treat diarrhea or constipation. To minimize drift when the treatment is disseminated to a large group of providers, patient education and other basic components of treatment are included in a DVD; however, nurse supervision to individualize treatment remains important. The study will be carried out in 8 counties in central North Carolina which are served by the University of North Carolina Home Health Care and Rex Home Health Care agencies (partners in this study). These counties will be randomly assigned to two groups approximately matched on urban vs. rural residence. For the first two years all patients in one group of counties will receive the active intervention while residents of the other counties receive usual care plus a DVD and symptom monitoring to control for expectancy. After two years, patients in all 8 counties will receive the active intervention. After excluding patients with severe cognitive impairment and those with stomas, we estimate 252 - 340 patients with FI who are over age 50 will receive treatment (at least 189 in active treatment and 63 controls). Specific aims are (1) to show that the active treatment is more effective than the control treatment for improving FI severity, patient quality of life, and caregiver burden, and that improvements are maintained for at least 6 months; (2) to identify moderators of treatment effectiveness (candidate variables are cognitive status, mobility impairment, willingness of family caregiver to assist with treatment, anxiety, depression, age, and race); and (3) to explore whether successful treatment of FI reduces the risk of nursing home referral. This is a revised application. PUBLIC HEALTH RELEVANCE: Fecal incontinence affects an estimated 15% of people aged 65 or older, and contributes to impaired quality of life and admission to a nursing home. Fewer than 10% of affected patients receive medical diagnosis and treatment. This study will test whether a simple treatment that yields 80% reductions in the frequency of fecal incontinence in laboratory studies, will work equally well when it is disseminated to health care providers in 4 counties of North Carolina.