Spina BifidaNCT03466996
Telemedicine in Spina Bifida Transition: A Pilot Study
A study testing Intervention group in people with Spina Bifida, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients >= 13 years with a diagnosis of spina bifida who are currently seen through the Children's of Alabama Multidisciplinary Spina Bifida Clinic
Who cannot join
- Patients without access to the internet.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read the 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
- Spina Bifida
- Being tested
- Intervention group, Standard of care group
- Keywords
- Transition to adult care, Telemedicine, Myelomeningocele
- Medical subject headings
- Spinal Dysraphism, Meningomyelocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
Also called Telemedicine group
More frequent follow up with face to face interaction.
Standard of care groupBehavioural
Transition goal setting during annual follow up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Secondary outcomes (2)
Healthcare utilization
Number of hospitalizations; ER and clinic visits.
Measured: Baseline to 24 months
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.
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start1 Jun 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Children's of Alabama
- Responsible party
- Principal investigator, Elizabeth Kuhn, University of Alabama at Birmingham
- Investigators
- Elizabeth Kuhn, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466996
- Sponsor's protocol ID
- IRB-555555
- Status last verified
- Oct 2021
- First submitted
- 9 Mar 2018
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine in Spina Bifida Transition: A Pilot Study
- ClinicalTrials.gov ID
- NCT03466996
- Acronym / sponsor ID
- IRB-555555
- Conditions
- Spina Bifida
- Keywords
- Transition to adult care, Telemedicine, Myelomeningocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Children's of Alabama
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupThe 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. |
| Standard of care group | Active comparator | Behavioral: Standard of care groupThe 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. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients >= 13 years with a diagnosis of spina bifida who are currently seen through the Children's of Alabama Multidisciplinary Spina Bifida Clinic
Key exclusion criteria (1 listed)
- Patients without access to the internet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupAlso: Telemedicine groupMore frequent follow up with face to face interaction. | Behavioural | Intervention group |
| Standard of care groupTransition goal setting during annual follow up. | Behavioural | Standard of care group |
Primary outcome
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).
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.
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.
2 secondary outcomes
Healthcare utilization
Time frame: Baseline to 24 months
Health care related cost
Time frame: Baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Kuhn, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Spina Bifida, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition preparedness (time frame: Baseline to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.