Telemedicine in Spina Bifida Transition: A Pilot Study

• ClinicalTrials.gov Identifier: NCT03466996
• Recruitment Status: Completed
• First Posted: March 15, 2018
• Last Update Posted: October 20, 2021
• Sponsor: University of Alabama at Birmingham
• Collaborator: Children's of Alabama
• Information provided by (Responsible Party): Elizabeth Kuhn, University of Alabama at Birmingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spina Bifida	Behavioral: Intervention group; Behavioral: Standard of care group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Telemedicine in Spina Bifida Transition: A Pilot Study
• Actual Study Start Date: June 1, 2018
• Actual Primary Completion Date: September 1, 2020
• Actual Study Completion Date: September 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; 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; More frequent follow up with face to face interaction.; Other Name: Telemedicine group
Active Comparator: Standard of care 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; Transition goal setting during annual follow up.

Outcome Measures

Primary Outcome Measures :

1. Transition preparedness [ Time Frame: 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).
2. Health-related quality of life [ Time Frame: 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.
3. Improvement in bowel management [ Time Frame: 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 Outcome Measures :

1. Healthcare utilization [ Time Frame: Baseline to 24 months ]
   Number of hospitalizations; ER and clinic visits.
2. Health care related cost [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Children's of Alabama

Investigators

• Principal Investigator: Elizabeth Kuhn, MD; University of Alabama at Birmingham

More Information

• Responsible Party: Elizabeth Kuhn, Principle Inverstigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03466996
• Other Study ID Numbers: IRB-555555
• First Posted: March 15, 2018
• Last Update Posted: October 20, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Kuhn, University of Alabama at Birmingham:

Transition to adult care; Telemedicine; Myelomeningocele

Additional relevant MeSH terms:

Spinal Dysraphism; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities