Nursing Management of Irritable Bowel Syndrome: Improving Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 4
- 主要终点
- Gastrointestinal symptoms
研究概览
简要总结
The purpose of this study is 1) to determine whether a comprehensive self-management intervention is effective in a sample that includes men and women with irritable bowel syndrome, and 2) to determine whether the comprehensive self-management intervention is as effective when delivered over the telephone as compared to a face-to-face approach.
详细描述
Randomization and Intervention Phase. Upon completing the baseline assessment phase, participants will be randomized to one of 3 treatment groups. A customized computer program will be used to do the randomization in an adaptive manner that ensures the 3 groups remain fairly balanced with respect to possible important predictors of outcomes: age, sex, predominant stool pattern (alternating, constipation-predominant or diarrhea-predominant), and severity of IBS symptoms and psychological symptoms at baseline. When each new participant is randomized, the program will adjust the probabilities of assignment to the three groups so that there is a higher probability of assignment to the group that results in the best balance.
Intervention Groups. Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.
Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-TEL group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.
Usual Care Control Group (UC). Following randomization the participants in the control group will no receive any contacts during the comparable 9-week intervention in the treatment groups.
Follow-up Phase. Participants in all 3 groups will be reassessed at 3-mo, 6-mo, and 12-mo post randomization. At this time the participants will complete questionnaires, a 4 week diary and collect 4 urines.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Irritable Bowel Syndrome
排除标准
- •GI pathology (organic disease)
- •Co-morbid pain disorders
结局指标
主要结局
Gastrointestinal symptoms
时间窗: baseline, and 3 months, 6 months, 12 months post randomization
Psychological distress
时间窗: baseline, and 3 months, 6 months, 12 months post randomization
Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders.
时间窗: baseline, and 3 months, 6 months, 12 months post randomization
Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire.
时间窗: baseline, and 3 months, 6 months, 12 months post randomization
次要结局
- Sleep disturbance(baseline, and 3 months, 6 months, 12 months post randomization)
- Sexual dysfunction(baseline, and 3 months, 6 months, 12 months post randomization)
- Catecholamine and cortisol levels (urine)(baseline, and 3 months, 6 months, 12 months post randomization)
- Stool frequency/consistency(baseline, and 3 months, 6 months, 12 months post randomization)
- Health care utilization(baseline, and 3 months, 6 months, 12 months post randomization)