Conservative Treatment of Fecal Incontinence: Community-Based Effectiveness Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Fecal Incontinence Severity Index (FISI) at End of Treatment
研究概览
简要总结
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.
详细描述
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. The investigators 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 printed training manual and are available to nurse providers on a website; 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). Nurses in these agencies will be randomly assigned to two groups. For the first two years all patients of the nurses in one group will receive the active intervention while all patients of nurses in the other group will receive usual care plus a training manual and symptom monitoring to control for expectancy. After two years, all patients in these home health care agencies will receive the active intervention. After excluding patients with severe cognitive impairment and those with stomas, the investigators 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported fecal incontinence at least once a month
- •Family caregiver available and willing to participate in treatment sessions and willing to assist patient with study procedures
- •Patients and caregivers willing to be interviewed by a research assistant in their home on three occasions
- •Onset of fecal incontinence more than 3 months previously (i.e., not transient fecal incontinence)
排除标准
- •Has a stoma or fecal incontinence status is unknown
- •Has fecal incontinence less than monthly
- •Severe cognitive impairment (response of 4 on OASIS question M1700)
研究组 & 干预措施
Educational-Medical-Behavioral
Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
干预措施: Education (Other)
Educational-Medical-Behavioral
Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
干预措施: Fiber supplements (Dietary Supplement)
Educational-Medical-Behavioral
Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
干预措施: Laxatives or anti-diarrheals (Drug)
Educational-Medical-Behavioral
Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
干预措施: Pelvic floor muscle exercises (Behavioral)
Educational-Medical-Behavioral
Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
干预措施: Tips on how to prevent fecal incontinence (Behavioral)
Educational-Medical-Behavioral
Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
干预措施: Daily diary (Behavioral)
Educational-Medical-Behavioral
Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
干预措施: Protective pads or garments (Other)
Standard Care
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
干预措施: Fiber supplements (Dietary Supplement)
Standard Care
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
干预措施: Daily diary (Behavioral)
Standard Care
Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
干预措施: Protective pads or garments (Other)
结局指标
主要结局
Fecal Incontinence Severity Index (FISI) at End of Treatment
时间窗: End of Treatment (Week 6)
At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.
Fecal Incontinence Severity Index (FISI) at Follow-Up (FU)
时间窗: 6 months after (6-Week) treatment ends
At follow up 6 months after the end of treatment, the subject reports the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range is 0-61. No data is available to interpret the scale as mild, moderate, or severe fecal incontinence.
次要结局
- MHQ Severity Scale at End of Treatment(End of Treatment (Week 6))
- Adequate Relief of Fecal Incontinence at End of Treatment(End of Treatment (Week 6))
- Adequate Relief of Fecal Incontinence at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Severity Scale at Follow Up(6 months after (6-Week) treatment ends)
- Zarit Caregiver Burden Scale at End of Treatment(End of Treatment (Week 6))
- Fecal Incontinence Frequency at End of Treatment(End of Treatment (Week 6))
- Urinary Incontinence Status Change From Baseline to End of Treatment(Baseline, end of treatment (week 6))
- Zarit Caregiver Burden Scale at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Role Limitations at End of Treatment(End of Treatment (Week 6))
- MHQ Role Limitations at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Physical Limitations at End of Treatment(End of Treatment (Week 6))
- MHQ Physical Limitations at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Social Limitations at End of Treatment(End of Treatment (Week 6))
- Admission to Nursing Home at End of Treatment(End of Treatment (Week 6))
- MHQ Incontinence Impact at End of Treatment(End of Treatment (Week 6))
- MHQ Incontinence Impact at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Personal Relationships at End of Treatment(End of Treatment (Week 6))
- MHQ Social Limitations at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Personal Relationships at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Emotions at End of Treatment(End of Treatment (Week 6))
- MHQ Emotions at Follow Up(6 months after (6-Week) treatment ends)
- MHQ Sleep Energy at End of Treatment(End of Treatment (Week 6))
- MHQ Sleep Energy at Follow Up(6 months after (6-Week) treatment ends)
研究者
William (Bill) Whitehead, PhD
Professor of Medicine and Adjunct Professor of OBGYN
University of North Carolina, Chapel Hill