Telemedicine in Spina Bifida Transition: A Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Telemedicine in Spina Bifida Transition: A Pilot Study

Conditions
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Spina Bifida

Intervention / Treatment
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* Behavioral: Intervention group
* Behavioral: Standard of care group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >= 13 years with a diagnosis of spina bifida who are currently seen through the Children's of Alabama Multidisciplinary Spina Bifida Clinic Exclusion Criteria: Patients without access to the internet.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* More frequent follow up with face to face interaction.<br>* Other names: Telemedicine group;|
| Active Comparator: Standard of care group<br>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<br>* Transition goal setting during annual follow up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare utilization | Number of hospitalizations; ER and clinic visits. | 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. | Baseline to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transition to adult care, Telemedicine, Myelomeningocele