Clinical Trials Directory

Trials / Completed

CompletedNCT03466996

Telemedicine in Spina Bifida Transition: A Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
13 Years – 25 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALIntervention groupMore frequent follow up with face to face interaction.
BEHAVIORALStandard of care groupTransition goal setting during annual follow up.

Timeline

Start date
2018-06-01
Primary completion
2020-09-01
Completion
2021-09-01
First posted
2018-03-15
Last updated
2021-10-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03466996. Inclusion in this directory is not an endorsement.