Nursing Management of Irritable Bowel Syndrome:Improving Outcomes
| Status: | Completed |
|---|---|
| Conditions: | Irritable Bowel Syndrome (IBS) |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/13/2017 |
| Start Date: | January 2003 |
| End Date: | February 2008 |
Nursing Management of Irritable Bowel Syndrome: Improving Outcomes
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.
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.
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.
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.
Inclusion Criteria:
- Irritable Bowel Syndrome
Exclusion Criteria:
- GI pathology (organic disease)
- Co-morbid pain disorders
We found this trial at
2
sites
Click here to add this to my saved trials
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Click here to add this to my saved trials