Telemedicine in Spina Bifida Transition: A Pilot Study

Spina Bifida Clinical Trial

Official title:

Telemedicine in Spina Bifida Transition: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466996
• Other study ID #: IRB-555555
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spina Bifida
• Spinal Dysraphism

Intervention

Behavioral:
• Intervention group
More frequent follow up with face to face interaction.
• Standard of care group
Transition goal setting during annual follow up.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Children's of Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Healthcare utilization	Number of hospitalizations; ER and clinic visits.	Baseline to 24 months
Secondary	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