Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167635
Status:
COMPLETED
Last Update Posted:
2009-05-25
First Post:
2005-09-09
Brief Title:
Nursing Management of Irritable Bowel SyndromeImproving Outcomes
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Nursing Management of Irritable Bowel Syndrome Improving Outcomes
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-3895-C 11 | None | None | None |
| 2R01NR04142-5 | None | None | None |