An interventional study of Intervention group and Standard of care group in Spina Bifida, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 13 Years to 25 Years. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Health services research
The purpose of this study is to explore the feasibility and efficacy of using telemedicine to improve transition from pediatric to adult care in patients with spina bifida.
After enrollment, patients will be randomly assigned to either the control or intervention group. Randomization will be performed using computer software with 1:1 group allocation. We anticipate 26 participants in each group.
The control group will receive the current standard of care transition program which includes goal-setting at their annual Multidisciplinary Spina Bifida Clinic visit. Additionally, they will receive encouragement e-mail and text messages. These messages will be sent at 2 weeks, 3 months, 6 months, and 9 months from last in-person appointment.
The intervention group will participate in face-to-face video telemedicine visits, in addition to routine yearly visits to the Spina Bifida Clinic. These 30-minute visits will occur at 2 weeks, 3 months, 6 months and 9 months from last in-person clinic appointment. The visits will consist of structured counseling using a plan-do-study-act cycle approach to incrementally adopt elements of a well-planned transition. Using qualitative notes from each session, I hypothesize that I will be able to identify common themes or challenges across patients and develop adjunctive education, support, and monitoring tools for patients and families in transition. I will collaborate with experts from orthopedic surgery, physical medicine and rehabilitation, urology, neurosurgery, nutrition, and psychology to develop content for educational tools.
142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
Browse Spinal Dysraphism studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
The intervention group will participate in face-to-face video telemedicine visits, in addition to routine annual visits to the Spina Bifida Clinic. These 30-minute visits will occur at 2 weeks, 3 months, 6 months and 9 months from last in-person clinic appointment. The visits will consist of structured counseling using a plan-do-study-act cycle approach to incrementally adopt elements of a well-planned transition. Using qualitative notes from each session, we will identify common themes or challenges across patients and develop adjunctive education, support, and monitoring tools for patients and families in transition.
Behavioral: Intervention group
The control group will receive the current standard of care transition program. In addition to this, they will receive encouraging text messages and e-mails relating to their transition goals. These messages will be sent 2 weeks, 3 months, 6 months and 9 months from the last in-person clinic appointment.
Behavioral: Standard of care group
More frequent follow up with face to face interaction.
Also known as: Telemedicine group
Transition goal setting during annual follow up.
Transition preparedness
Transition preparedness will be assessed using Transition Readiness Assessment Questionnaire (TRAQ), a validated, patient-centered questionnaire. Each item is scored 1-5, with 1 being assigned for responses of "No, I do not know how"(not ready for transition) and a score of 5 assigned for responses of "Yes, I always do this when I need to."(ready for transition).
Time frame: Baseline to 12 months
Health-related quality of life
Health-related quality of life (HRQoL) will be assessed using the generic Pediatric Quality of Life InventoryTM (PedsQLTM). 0-100 scale, the higher scores indicate better quality of life.
Time frame: Baseline to 12 months
Improvement in bowel management
Spina bifida-specific Quality of Life Assessment in Spina Bifida for Children (QUALAS-C) (a measure of bowel and bladder-related HRQoL). QUALAS-T is scored 0-100, where higher values signify higher HRQOL.
Time frame: Baseline to 12 months
Healthcare utilization
Number of hospitalizations; ER and clinic visits.
Time frame: Baseline to 24 months
Health care related cost
We will track number of hospitalizations, ER and clinic visits as related to cost. The goal is to reduce these visits.
Time frame: Baseline to 24 months
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →