Conservative Treatment of Fecal Incontinence in the Elderly: Effectiveness T

老年人大便失禁的保守治疗：有效性 T

• 批准号: 8129103
• 负责人: WILLIAM E WHITEHEAD
• 金额: $ 45.39万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-01 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8129103
• 关键词: Conservative; Treatment; Fecal; Incontinence; Elderly

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.

描述（由申请人提供）：大便失禁 (FI) 影响 9% 的美国成年人，每周或更频繁地发生，占 2.7%。患病率随着年龄的增长而增加，到 70 岁时达到 15%。 FI 对生活质量具有毁灭性影响，并且当患者患有需要护理人员协助的合并症时，会大大增加护理人员的负担。我们提出了一项有效性试验，其总体目标是确定在单中心研究中被证明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够维持其功效。治疗包括对患者进行有关如何维持节制的生理学教育、盆底锻炼、预防 FI 的行为策略以及使用纤维或非处方药物治疗腹泻或便秘。为了最大限度地减少治疗向大量提供者传播时的偏差，患者教育和治疗的其他基本组成部分都包含在 DVD 中；然而，护士对个体化治疗的监督仍然很重要。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医疗保健机构和雷克斯家庭医疗保健机构（本研究的合作伙伴）提供服务。这些县将被随机分配到城市与农村居住情况大致匹配的两组。在头两年中，一组县的所有患者都将接受积极干预，而其他县的居民则接受常规护理以及 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。排除严重认知障碍患者和造口患者后，我们估计 252 - 340 名 50 岁以上的 FI 患者将接受治疗（至少 189 名接受积极治疗，63 名对照）。具体目标是 (1) 证明积极治疗比对照治疗更能有效改善 FI 严重程度、患者生活质量和护理人员负担，并且改善至少维持 6 个月； (2) 确定治疗效果的调节因素（候选变量包括认知状态、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 的成功治疗是否可以降低疗养院转诊的风险。这是修改后的应用程序。 公共卫生相关性：估计 15% 的 65 岁或以上的人患有大便失禁，并导致生活质量下降和入住疗养院。不到10%的受影响患者得到医疗诊断和治疗。这项研究将测试实验室研究中一种可将大便失禁频率降低 80% 的简单治疗方法在向北卡罗来纳州 4 个县的医疗保健提供者传播时是否同样有效。