Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Jill Ketzer
CONTACT
Andrea Bischoff, MD
CONTACT
Lead
University of Colorado, Denver
Patients meeting inclusion criteria will be enrolled while they are here on campus for a regular clinic visit. Once they consent, they will complete a baseline survey, and will be given the FCAD with the instruction manual and the investigators will go over how to use the device and answer any questions. The PI will be available throughout the study for any questions that may arise. Participants will use the device for their regular enemas for up to 4 weeks. If the device is negatively impacting enema administration, they can choose to stop using the device at any time but it is preferable that participants use the device five times before they decide it is not working for them. Once a participant has used the device for 1 week or has chosen to opt out of completing the 4-week trial, they will complete a second survey. After 4 weeks, or if they have chosen to opt out of completing the 4-week trial, they will complete a third survey. The baseline survey will assess how current enema administration practices are going and the second and third surveys will assess how well enema administration is going while using the device. If time allows and user feedback indicates a need, the device will be modified, and participants will be asked to use the second version for up to 4 weeks. Again, if the device is negatively impacting enema administration, they can choose to stop using the second version of the device at any time but it's preferable that participants use it five times before deciding it is not working for them. Once a participant has used the second version of the device for 1 and then again at 4 weeks or chosen to opt out of completing the 4-week trial, they will complete a fourth and fifth survey assessing the second version of the device. If traveling to CHCO is not convenient, the second version of the device will be mailed to the participant, and they will complete the surveys via email or over the phone. This eliminates the need for a return trip to CHCO. REDCap will be used for all surveys. If participants are not able to complete the surveys electronically for any reason, they will complete a hardcopy version, or the survey will be administered over the phone, whichever is convenient for the participant.
Age
2–30
Sex
ALL
Healthy volunteers
Not accepted
