- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03410667
Incontinence and Quality of Life in Children With Spina Bifida
A Patient-centered Approach to Urinary Incontinence and Quality of Life in Children and Adolescents With Spina Bifida
Study Overview
Status
Conditions
Detailed Description
Phase 1: Stakeholder Group. The investigators will engage 30 dyads of children and adolescents with spina bifida aged 8-17 years old, who experienced any urinary and fecal incontinence in the past 4 weeks, and their caregivers in the exploration phase. These children and adolescents will be identified from among spina bifida patients receiving care from pediatric urology providers at Riley Hospital for Children, Indiana University Health. As part of the exploration process, it is important to include patients that reflect the varied life experiences of those impacted by spina bifida. Therefore, the investigators will aim to include children and adolescents with a range of physical and cognitive developmental delays. Groups will be separated by gender to facilitate discussion and elicit any gender-specific urinary incontinence goals. The patient engagement core will create a smartphone-based "Day in the Life" diary toolkit that will be provided to the stakeholder group. The stakeholders will be asked to self-report their experiences and perspectives as they relate to being a child or adolescent with spina bifida and urinary and fecal incontinence, or taking care of someone with spina bifida with urinary incontinence. Stakeholders will be asked to respond using video to various prompts such as documenting a typical day in their life, sharing their experiences. After completing the requested tasks, stakeholders will return the toolkit to the patient engagement. These self-reporting tools will be designed to be as usable as possible by as many participants as possible, taking into account common barriers caused by this condition, and relying on caregivers, as needed, to administer the tools. Investigators anticipate that the kit will take approximately 3 hours to complete. Through analysis and translation of the diaries and video, the patient engagement core will identify insights into patient-centered UI goals and areas of opportunity for design solutions. These identified opportunity spaces will inform the work for Phase Two, the creation phase.
Phase 2: In order to achieve a holistic and sustainable intervention, it is crucial that the investigators work with an interdisciplinary team that include designers, researchers, patients, family members, other caregivers, and health care providers in the process of creating the intervention. Therefore, the investigators will invite 8-10 of the dyads from Phase One to participate as members of the Co-Design Panel which will be brought together to participate in a 2-4 hour co-design session. During this session, designers will share the insights gained from Phase One work. Panel participants will be asked to help refine these insights to define domains of patient-centered urinary incontinence goals. From there, the Co-Design Panel will work to generate solutions for a tool to facilitate goal-setting and follow-up related to these domains (i.e., the tool, or app). This will be done through a series of generative, prototyping exercises with participants. For example, the group could work in small teams to generate ideas for their ideal goal-setting tool and then use sketches, storyboards, building materials like foam core, or verbal story-telling to prototype these ideas. The options for prototyping will be diverse to accommodate a spectrum of physical and cognitive abilities. These prototypes can then be used to generate discussion among the Co-Design Panel, which will further refine the ideal aspects of the app from the perspective of children and adolescents with SB and their caregivers.
The Physician Panel will then be invited to respond to a prototype of the app and give their input on how it can be improved to best fit into clinic workflow, address physician preferences, and work for a variety of patient-physician scenarios. These responses will be gathered through structured in-person interviews.
Phase 3: The investigators will ask patient/caregiver dyads with spina bifida (N=8), who were not part of the Co-Design Panel in Phase Two, to utilize the tool in conjunction with their pediatric urologist during a pediatric urology clinic visit at Riley Hospital. The investigators will comply with all IRB requirements at the study institution for the inclusion of patients in research, including obtaining the necessary consents/assents.
Testing Process. Following the clinic visit, the patient/caregiver will participate in Cognitive Interviews. They will be asked to describe their impressions of the prototype app through the use of scripted verbal probes ("What do you think is being represented here?" "Describe what you would do next.") and spontaneous probes ("What about this picture/sentence/etc., makes you feel that way?"), the investigators will determine if the prototype app is functioning as expected, or any key elements were missed. The investigators will also ask for feedback from the urologists on how well the tool functioned within the clinic setting to help in this iterative validation process. This will be accomplished by conducting interviews with approximately 6 physicians.
Phase 4: The investigators will recruit children and adolescents with SB (8-17 years old) who are followed at Riley Hospital Pediatric Urology Outpatient Clinic and their primary caregiver. The primary caregiver must be the patient's legal guardian. Well over 200 children and adolescents with SB are seen at this facility annually. Each week, a research assistant (RA) will be given a list of SB patients within the desired age range who have an upcoming appointment in two settings: the Pediatric Urology Clinic or the multidisciplinary Spina Bifida clinic. The RA will approach the patient and their primary caregiver upon arrival at the clinic appointment to gauge their interest in study participation. If the dyad indicates potential interest, the RA will take them to a private area to further discuss the details of the study, determine eligibility, and then obtain consent from the legal caregiver and assent from the patient wishing to enroll in the study. Over a 12-month period, the investigators will enroll 92 children and adolescents with SB and their primary caregivers. After enrollment in the study, the RA will administer the app, and collect baseline data regarding self-reported urinary and fecal incontinence and HRQOL. The patient and their caregiver will then meet with their urologist for the scheduled clinic appointment. After being enrolled at baseline, participants will continue with standard care for 12 months (while completing UI, HRQOL, and other questionnaires), at which point the app is introduced and the goal is set, and then they are followed for another 12 months. The urologist will be provided with the completed app and will utilize this tool to verify/discuss the goal selected, and then discuss plans for treatment in order to achieve this goal. Goal attainment, UI, and HRQOL will be assessed at 6 and 12 months after the app is introduced. Children with SB are typically seen in the outpatient clinic every 6-12 months. Therefore, these follow-up assessments will occur in-person at a clinic appointment, or, if not possible, investigators will contact the participant by telephone to notify them that an email link to a secure website to complete the necessary assessments will be sent. To minimize loss to follow-up, investigators will ask for 3 different phone numbers with at least one being a landline (if available). Investigators will also ask for two email addresses. Up to 3 attempts will be made to reach participants.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeremy Koehlinger, MT, CCRP
- Phone Number: (317) 274-1615
- Email: jkoehlin@iupui.edu
Study Contact Backup
- Name: Konrad Szymanski, MD, MHA
- Phone Number: (317) 948-4777
- Email: szymanko@iupui.edu
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Riley Hospital for Children
-
Contact:
- Jeremy Koehlinger
- Phone Number: 317-274-1615
- Email: jkoehlin@iupui.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Spina bifida
- 8-17 years old
- Followed at Riley Hospital Pediatric Urology Outpatient Clinic
- Primary caregiver is patient's legal guardian
- Urinary incontinence in the past 4 weeks
- Fecal incontinence in the past 4 weeks
- Normal to mildly impaired cognitive development
- English language literacy
- Intent to receive care at the Riley Pediatric Urology Clinic for th extent of the study
The physician panel will be composed of pediatric urologists.
Exclusion Criteria:
- Children with significant cognitive impairment, as they will not be able to express their urinary and fecal incontinence goals.
- Patients who underwent a genitourinary procedure or a bowel procedure in the past 4 weeks, since these patients are often temporarily catheterized and therefore not experiencing their typical level of urinary and fecal incontinence.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Standard Care
Standard of care arm
|
Spina Bifida patients from the pediatric urology clinic at Riley Hospital and their caregivers will participate in discussions of UI goals.
These patients will self report their experiences and perspectives using a "Day in the Life" diary tool-kit.
Patients, caregivers and providers will work to create a goal setting tool to help patients and physicians appropriately address the issue of UI in patients with spina bifida.
This is a validation step to test whether the goal-setting tool is widely applicable and functional in a clinic setting.
There will be cognitive interviews after the tool is completed to gather patient impressions.
|
Experimental: Intervention Arm
Intervention arm
|
This will be a large scale validation of the app, with assignment to standard care for the first year of enrollment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SB-specific HRQOL
Time Frame: 2 years
|
The primary outcome, SB-specific HRQOL, will be evaluated using the validated 10-item QUAlity of Life ASsessment in Children/Teenagers (QUALAS-C/T) questionnaire.
Scores range from 0 to 100, with higher scores signifying better HRQOL.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
UI Goal selection and attainement
Time Frame: 2 years
|
Goals and goal attainment will be assessed using the MyGoal tool.
Patients who select a UI goal will be considered to be concerned about UI and offered UI treatments.
Those who do not select a UI goal will be considered not to be concerned.
Self-reported goal attainment will be categorized as: attained, not attained, and goal initially not identified.
|
2 years
|
Shared decision making
Time Frame: 2 years
|
SDM will be evaluated with the 9-item Shared Decision Making questionnaire (SDM-Q-9).
Scores range from 0 to 100, with higher scores signifying better SDM.
|
2 years
|
Patient-provider communication
Time Frame: 2 years
|
This will be evaluated with a 13-item Health Care Climate Questionnaire (HCCQ).
Scores range from 1 to 7, with higher scores signifying better patient-provider communication.
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1707207063
- 5K23DK119368 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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