Website for Self-Management of Fecal Incontinence

描述（由申请人提供）：大便失禁（FI）影响9%的非住院美国成年人（70岁以上占15%）。频繁或大量的FI通常会导致情绪困扰、社会孤立和失业，并增加进入养老院的可能性。生物反馈和骶神经刺激是有效的治疗方法，但这些方法都很昂贵，而且应用范围不广。此外，超过70%的FI患者没有向医生报告，而是试图自行治疗。我们的团队开发了一种保守的治疗方案，包括患者教育、盆底锻炼和粪便纤维或药物一致性的正常化，可将FI发作频率降低60-80%，并使多达66%的患者成为尿失禁。这种程度的改善可能足以使大多数患者保持独立。目的：我们的长期目标是建立一个基于保守治疗方案的自我管理网站，使FI患者可以作为医疗管理的辅助手段。要将目前护士主导的治疗方案转变为有效的自我管理工具，需要进行以下修改：(1)将患者教育部分重新设计为15-20分钟的模块，然后进行小测验和再培训，以确保掌握。(2)制作互动式患者日记，根据前一周的意外发生频率和大便一致性调整治疗目标，并对训练进度和症状变化进行图形化反馈。(3)建立一个有答案的常见问题库。(4)设计网站，使家庭照顾者能够帮助认知缺陷或其他残疾患者坚持治疗方案。本R21申请的目的是(a)设计网站以满足上述4个子目标，(b)收集初步结果数据，用于设计随机对照试验（未来R01）。方法：为了实现第一个目标，从信息网站（www.aboutincontinence.org, www.med.unc.edu\IBS）和医生转诊中招募的6-10名FI患者组成的小组将被要求完成每个教育模块，并以0-10的等级对说明的可理解性、执行难度和网站内容的相关性进行评分。这个过程将是迭代的，当一个小组完成一个教育模块时，网站将根据他们的评分进行修改，新的小组将被要求测试修改后的网站内容，直到可理解性和相关性的平均评分为>7/10，他们对每个教育模块和互动日记的难度评分为<3/10。目标2将通过在北卡罗来纳州和弗吉尼亚州招募一组60名FI患者来解决，他们将完成自我管理协议。我们将在治疗前后评估FI频率、FI严重程度和FI生活质量，并要求这些患者就该计划的可理解性、难度和相关性提供反馈。

DESCRIPTION (provided by applicant): Fecal incontinence (FI), affects 9% of non-institutionalized U.S. adults (15% of those over age 70). Frequent or large volume FI often leads to emotional distress, social isolation and job loss, and increases the likelihood of admission to a nursing home. Effective treatments are available in the form of biofeedback and sacral nerve stimulation, but these are expensive and not widely available. Moreover, more than 70% of patients with FI do not report it to a physician but attempt to manage on their own. Our team has developed a conservative treatment protocol involving patient education, pelvic floor exercises, and normalization of stool consistency with fiber or medication which reduces FI episode frequency by 60-80% and enables as many as 66% of patients to become continent. This degree of improvement may be enough to enable most patients to remain independent. Aims: Our long-term goal is to develop a self-management website based on this conservative treatment protocol which persons with FI can use as an adjunct to medical management. The following modifications are needed to change the current nurse-led treatment protocol into an effective self-management tool: (1) Redesign the patient education component into 15-20 minute modules followed by quizzes and retraining to insure mastery. (2) Develop an interactive patient diary which adjusts treatment targets based on the frequency of accidents and consistency of stools during the previous week, with graphical feedback of training progress and symptom change. (3) Develop a bank of frequently asked questions with answers. (4) Design the website so that family caregivers can assist patients with cognitive deficits or other disabilities to adhere to the treatment program. The aims of this R21 application are (a) to design the website to address the 4 subgoals listed above, and (b) to collect preliminary outcome data which will be used to design a randomized controlled trial (future R01). Methods: To address the first aim, small groups of 6-10 FI patients recruited from informational websites including www.aboutincontinence.org, www.med.unc.edu\IBS and from physician referrals will be asked to complete each educational module and to rate on a 0-10 scale the understandability of instructions, performance difficulty, and relevance of the website content. The process will be iterative such that, when a small group completes an educational module, the website will be modified based on their ratings, and new groups will be asked to test the modified website content until the average rating of understandability and relevance are >7/10 and their rating of difficulty is <3/10 for each educational module and for the interactive diary. Aim 2 will be addressed by recruiting a new group of 60 FI patients in North Carolina and Virginia who will complete the self-management protocol. We will evaluate FI frequency, FI severity and FI quality of life before and after treatment, and will ask these patients to provide feedback on the understandability, difficulty, and relevance of the program.