NCT03466996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

2.3 years

First QC Date

March 9, 2018

Last Update Submit

October 19, 2021

Conditions

Spina Bifida

Keywords

Transition to adult careTelemedicineMyelomeningocele

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Healthcare utilization

    Baseline to 24 months

  • Health care related cost

    Baseline to 24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Standard of care group

ACTIVE COMPARATOR

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

Interventions

Intervention groupBEHAVIORAL

More frequent follow up with face to face interaction.

Also known as: Telemedicine group
Intervention group
Standard of care groupBEHAVIORAL

Transition goal setting during annual follow up.

Standard of care group

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients \>= 13 years with a diagnosis of spina bifida who are currently seen through the Children's of Alabama Multidisciplinary Spina Bifida Clinic

You may not qualify if:

  • Patients without access to the internet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Spinal DysraphismMeningomyelocele

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Elizabeth Kuhn, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Inverstigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 15, 2018

Study Start

June 1, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

US(1)