Spina Bifida
Conditions
Keywords
Transition to adult care, Telemedicine, Myelomeningocele
Brief summary
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
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.
Interventions
BEHAVIORALIntervention group
More frequent follow up with face to face interaction.
BEHAVIORALStandard of care group
Transition goal setting during annual follow up.
Sponsors
Children's of Alabama
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition preparedness | Baseline to 12 months | 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). |
| Health-related quality of life | Baseline to 12 months | 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. |
| Improvement in bowel management | Baseline to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare utilization | Baseline to 24 months | Number of hospitalizations; ER and clinic visits. |
| Health care related cost | Baseline to 24 months | We will track number of hospitalizations, ER and clinic visits as related to cost. The goal is to reduce these visits. |
Countries
United States
Outcome results
None listed