Ignite Creation Date:
2024-05-06 @ 8:40 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02798783
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2016-06-03
Brief Title:
Enlarged Vestibular Aqueduct Registry
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Enlarged Vestibular Aqueduct Patient Registry at University Hospitals Rainbow Babies and Childrens Hospital
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVAR
Brief Summary:
People with the congenital anatomical malformation known as Enlarged Vestibular Aqueduct EVA may experience decline in hearing ability This is an online registry to gather patient experiences with EVA with the goal of providing future researchers with the information necessary to better evaluate and make recommendations for patients with EVA Data will be obtained from volunteers who enroll and submit their information on a website httpsevauhhospitalsorg and a limited data set may be provided to researchers interested in analyzing repository data The limited data set would not contain any identifiable information except for ages dates such as date of diagnosis or citystate of residence
EVA Research Project Website httprainboworgEVAResearch
EVA Patient Registry Website httpsevauhhospitalsorg
EVA Research Project Website httprainboworgEVAResearch
EVA Patient Registry Website httpsevauhhospitalsorg
Detailed Description:
Study design
The present study would employ a prospective questionnaire and retrospective chart review to develop a centralized registry of EVA patient information The questionnaire would be administered using custom-designed software and an internet web site that uses secure information transfer protocol and encryption Given authorization for the release of Protected Health Information PHI respective clinicians would be contacted for medical records that would be entered alongside corresponding self-reported data Interested researchers will be allowed to obtain data given their respective institutions Institutional Review Board IRB approval and documentation thereof The study would initially continue for four years and continue based on enrollment numbers and data requests
Study procedure
Collection methods would be chosen by the participant and can include one or both of a questionnaire andor Authorization for the Release of PHI and relevant medical records retrieval
Implementation of this project would involve three separate components participant data collection and interaction if authorized PHI retrieval and data provision to interested researchers
Questionnaire Data Collection
Upon providing an electronic signature participants will be taken to a page where they can begin the questionnaire Patients who begin the questionnaire will be presented with web pages asking for history relating to EVA Please note that these web pages all offer the option to exit the questionnaire Patients who elect to provide the Authorization for the Release of PHI will be provided the form to print and mail to the study center University Hospitals Case Medical Center
Clinical Data Retrieval and Data Quality
For those participants who do provide Authorization for the Release of PHI the clinicians whose information was included on the authorization form will be contacted and information requested This process would involve a transfer of the Authorization for the Release of PHI in one of two ways either by mail or via fax Clinicians who are willing to provide information will be instructed to transmit via fax or mail health data to the otolaryngology department at University Hospitals
Health data that is received will be reviewed and input into forms similar to those that the patients fill Such a mechanism will provide redundancy to data provided by participants thus ensuring the quality of this data
Providing Data to Researchers
The data that is collected will cover a range of topics related to EVA and will be held with the aim of providing subsets of the data to interested researchers who have IRB approval from their own institutions A form on the website will list fields for interested researchers to complete including upload of an IRB protocol Interested researchers would also be required to complete a Data Use Agreement
Informed consent procedure
Consent will be obtained electronically and stored separately from patient data such that identifiable information will only be linked to healthcare data using a patient identification ID number
Potential participants who elect to visit the EVAR website would be presented with an option to participate in the EVAR From there participants would be directed to an informed consent web page that contains all of the same information that would be in a written informed consent a blank version of which is provided in attached documents The web site would have a field where participants can type their name and the date to signify consent and another field where participants if applicable can type their name and the date to signify assent Completion of such a field would be considered equivalent to written consent and is referred to in this document as an electronic signature
Only after completing an electronic consent would potential participants be allowed to share questionnaire or authorization information This means that before seeing the questionnaire or authorization for the release of protected health information the participant would be required to provide electronic consent
The consent document itself would be provided to all potential participants in the form of a downloadable Portable Document Format PDF file and as a separate html web page that does not have a section where consent may be entered This twofold approach will ensure that potential participants can both view the consent in their web browser using the html version and print the PDF consent in the format that it was accepted by the University Hospitals IRB
Authorization to Release PHI Procedure
After providing an electronic signature for the informed consent participants will have the opportunity to complete an Authorization to Release PHI form Please see attachments for an example of this form
Participants who provide the information necessary to fill this form would be given the option of printing the form for themselves or receiving the form in the mail with return postage In either case the form would be populated with participant-provided data and provided such that only a participant signature and date would be needed to complete the form For participants who elect to receive the form in the mail two copies would be provided to allow the participant to keep one In either case participants would be asked to sign and date the document and mail it to the Otolaryngology Department at University Hospitals Case Medical Center UHCMC Original documents would be copied and along with the copy stored in a locked cabinet that is in a normally locked office on the UHCMC campus
Data security
Data transfer will occur using secure internet protocol using computers physically located on a University Hospitals campusParticipant information will be maintained in a secure HIPAA-compliant server located on a University Hospitals campus Only database developers and study personnel will have access to this data For patients who provide Authorization to release PHI data will only be received via fax mail or through University Hospitals email and will be stored on secure University Hospitals servers
Identifiable information will be protected from improper use or disclosure by storing data on a secure server located on the University Hospitals campus When submitting data over the internet participants will be connecting directly with University Hospitals servers using secure https protocol such that there will be no data access to anyone outside of the participant and server
For patients who provide Authorization to release PHI data will only be received via fax mail or through University Hospitals email
Identifiable information will not be reused or disclosed to any other person or entity outside University Hospitals other than those identified in the protocol except as required by law for authorized oversight of this research study or as specifically approved for use in another study by an IRB Any access to the website or data itself will be reviewed on a monthly basis
Statistical analysis and sample size calculations
Data on such a wide variety of patient experience measures is unavailable to determine effect sizes and subsequent minimum sample sizes particularly for an end-point with likely high variability such as self-reported hearing loss For this reason and to ensure greatest possible discrimination of effects the EVA registry will be open to as many people as are willing to enroll Previously a mailing list for interested participants was created and 53 people signed up over the course of three weeks Sizes of online special interest groups such as the Yahoo group httphealthgroupsyahoocomgroupLVAS have between 1000 and 3000 registered users Given mailing list interest and other online community sizes the investigators expect 300 participants to enroll
Statistical methods will be left to researchers who request this data but the data has been organized to facilitate descriptive and model-based statistical characterization of the EVA population Hearing loss progression may be evaluated in multiple dimensions particularly in relation to events such as head trauma or flying For example such categories of treatment head trauma flying are amenable to analysis with respect to outcomes hearing loss progression by such tests as the Chi-square test Other researchers may be interested in understanding the time taken to diagnose EVA in which case the interval between date of birth and date of first imaging study can be modeled with respect to other available data points
Data elements to be collected
Part 1 - Demographics
Relationship of respondent to patient
Patient
Date of Birth
Gender
City
State
Guardian
Date of Birth
Gender
City
State
Contact
Email
Phone
Part 2 - Initial Findings
Age at diagnosis of hearing loss
Diagnostic method
Audiogram Otoacoustic Emissions Testing Auditory Brainstem Response or other
Age at first imaging study
First image type
Computed Tomography CT or Magnetic Resonance Imaging MRI
Imaging results
Which ear has EVA
Left right or both
Diameter of the vestibular aqueduct
Part 3 - Progression
Has there been progression of hearing loss
Date and age of progression of hearing loss diagnosis - also commands
Events that contributed to hearing loss open text box
Did the family notice hearing loss or its event
Was the hearing loss recognized coincidentally on a hearing screenroutine audiogram
Was the patient treated for hearing loss
Check boxes for treatment with steroids or other
Part 4 - Trauma and Flying
Has the patient had any documented head trauma
Date and age of trauma - also commands
Was there any associated hearing loss
What additional testing was performed if any
Was additional imaging done
Has the patient flown
Was there any subjective worsening of hearing
Was additional testing required after flying
Part 5 - Family History
Is there any family history of hearing loss
Is there any family history of EVA
Has any genetics testing been completed
If so what type of testing
At what age
What were the results
Does the patient have Pendred syndrome
Part 6 - Aids
Does the patient receive speech therapy
If so how often
At what age did speech therapy begin
Does the patient use a Frequency Modulation FM system at school
Does the patient use a hearing aid
If so in which ear
Starting at what year of age
Does the patient have a cochlear implant
If so in which ear
What year was the operation performed
If two implants were they done at the same time
At what age was the operation performed
How long after diagnosis of hearing loss was the operation performed
How long after diagnosis of EVA was the operation performed
Part 7 - Vertigo
Has the patient ever had balance problems or vertigo
If so how frequently
How severe
Are there triggering activities
At what age was the first episode
How long after diagnosis did vertigo occur
The present study would employ a prospective questionnaire and retrospective chart review to develop a centralized registry of EVA patient information The questionnaire would be administered using custom-designed software and an internet web site that uses secure information transfer protocol and encryption Given authorization for the release of Protected Health Information PHI respective clinicians would be contacted for medical records that would be entered alongside corresponding self-reported data Interested researchers will be allowed to obtain data given their respective institutions Institutional Review Board IRB approval and documentation thereof The study would initially continue for four years and continue based on enrollment numbers and data requests
Study procedure
Collection methods would be chosen by the participant and can include one or both of a questionnaire andor Authorization for the Release of PHI and relevant medical records retrieval
Implementation of this project would involve three separate components participant data collection and interaction if authorized PHI retrieval and data provision to interested researchers
Questionnaire Data Collection
Upon providing an electronic signature participants will be taken to a page where they can begin the questionnaire Patients who begin the questionnaire will be presented with web pages asking for history relating to EVA Please note that these web pages all offer the option to exit the questionnaire Patients who elect to provide the Authorization for the Release of PHI will be provided the form to print and mail to the study center University Hospitals Case Medical Center
Clinical Data Retrieval and Data Quality
For those participants who do provide Authorization for the Release of PHI the clinicians whose information was included on the authorization form will be contacted and information requested This process would involve a transfer of the Authorization for the Release of PHI in one of two ways either by mail or via fax Clinicians who are willing to provide information will be instructed to transmit via fax or mail health data to the otolaryngology department at University Hospitals
Health data that is received will be reviewed and input into forms similar to those that the patients fill Such a mechanism will provide redundancy to data provided by participants thus ensuring the quality of this data
Providing Data to Researchers
The data that is collected will cover a range of topics related to EVA and will be held with the aim of providing subsets of the data to interested researchers who have IRB approval from their own institutions A form on the website will list fields for interested researchers to complete including upload of an IRB protocol Interested researchers would also be required to complete a Data Use Agreement
Informed consent procedure
Consent will be obtained electronically and stored separately from patient data such that identifiable information will only be linked to healthcare data using a patient identification ID number
Potential participants who elect to visit the EVAR website would be presented with an option to participate in the EVAR From there participants would be directed to an informed consent web page that contains all of the same information that would be in a written informed consent a blank version of which is provided in attached documents The web site would have a field where participants can type their name and the date to signify consent and another field where participants if applicable can type their name and the date to signify assent Completion of such a field would be considered equivalent to written consent and is referred to in this document as an electronic signature
Only after completing an electronic consent would potential participants be allowed to share questionnaire or authorization information This means that before seeing the questionnaire or authorization for the release of protected health information the participant would be required to provide electronic consent
The consent document itself would be provided to all potential participants in the form of a downloadable Portable Document Format PDF file and as a separate html web page that does not have a section where consent may be entered This twofold approach will ensure that potential participants can both view the consent in their web browser using the html version and print the PDF consent in the format that it was accepted by the University Hospitals IRB
Authorization to Release PHI Procedure
After providing an electronic signature for the informed consent participants will have the opportunity to complete an Authorization to Release PHI form Please see attachments for an example of this form
Participants who provide the information necessary to fill this form would be given the option of printing the form for themselves or receiving the form in the mail with return postage In either case the form would be populated with participant-provided data and provided such that only a participant signature and date would be needed to complete the form For participants who elect to receive the form in the mail two copies would be provided to allow the participant to keep one In either case participants would be asked to sign and date the document and mail it to the Otolaryngology Department at University Hospitals Case Medical Center UHCMC Original documents would be copied and along with the copy stored in a locked cabinet that is in a normally locked office on the UHCMC campus
Data security
Data transfer will occur using secure internet protocol using computers physically located on a University Hospitals campusParticipant information will be maintained in a secure HIPAA-compliant server located on a University Hospitals campus Only database developers and study personnel will have access to this data For patients who provide Authorization to release PHI data will only be received via fax mail or through University Hospitals email and will be stored on secure University Hospitals servers
Identifiable information will be protected from improper use or disclosure by storing data on a secure server located on the University Hospitals campus When submitting data over the internet participants will be connecting directly with University Hospitals servers using secure https protocol such that there will be no data access to anyone outside of the participant and server
For patients who provide Authorization to release PHI data will only be received via fax mail or through University Hospitals email
Identifiable information will not be reused or disclosed to any other person or entity outside University Hospitals other than those identified in the protocol except as required by law for authorized oversight of this research study or as specifically approved for use in another study by an IRB Any access to the website or data itself will be reviewed on a monthly basis
Statistical analysis and sample size calculations
Data on such a wide variety of patient experience measures is unavailable to determine effect sizes and subsequent minimum sample sizes particularly for an end-point with likely high variability such as self-reported hearing loss For this reason and to ensure greatest possible discrimination of effects the EVA registry will be open to as many people as are willing to enroll Previously a mailing list for interested participants was created and 53 people signed up over the course of three weeks Sizes of online special interest groups such as the Yahoo group httphealthgroupsyahoocomgroupLVAS have between 1000 and 3000 registered users Given mailing list interest and other online community sizes the investigators expect 300 participants to enroll
Statistical methods will be left to researchers who request this data but the data has been organized to facilitate descriptive and model-based statistical characterization of the EVA population Hearing loss progression may be evaluated in multiple dimensions particularly in relation to events such as head trauma or flying For example such categories of treatment head trauma flying are amenable to analysis with respect to outcomes hearing loss progression by such tests as the Chi-square test Other researchers may be interested in understanding the time taken to diagnose EVA in which case the interval between date of birth and date of first imaging study can be modeled with respect to other available data points
Data elements to be collected
Part 1 - Demographics
Relationship of respondent to patient
Patient
Date of Birth
Gender
City
State
Guardian
Date of Birth
Gender
City
State
Contact
Phone
Part 2 - Initial Findings
Age at diagnosis of hearing loss
Diagnostic method
Audiogram Otoacoustic Emissions Testing Auditory Brainstem Response or other
Age at first imaging study
First image type
Computed Tomography CT or Magnetic Resonance Imaging MRI
Imaging results
Which ear has EVA
Left right or both
Diameter of the vestibular aqueduct
Part 3 - Progression
Has there been progression of hearing loss
Date and age of progression of hearing loss diagnosis - also commands
Events that contributed to hearing loss open text box
Did the family notice hearing loss or its event
Was the hearing loss recognized coincidentally on a hearing screenroutine audiogram
Was the patient treated for hearing loss
Check boxes for treatment with steroids or other
Part 4 - Trauma and Flying
Has the patient had any documented head trauma
Date and age of trauma - also commands
Was there any associated hearing loss
What additional testing was performed if any
Was additional imaging done
Has the patient flown
Was there any subjective worsening of hearing
Was additional testing required after flying
Part 5 - Family History
Is there any family history of hearing loss
Is there any family history of EVA
Has any genetics testing been completed
If so what type of testing
At what age
What were the results
Does the patient have Pendred syndrome
Part 6 - Aids
Does the patient receive speech therapy
If so how often
At what age did speech therapy begin
Does the patient use a Frequency Modulation FM system at school
Does the patient use a hearing aid
If so in which ear
Starting at what year of age
Does the patient have a cochlear implant
If so in which ear
What year was the operation performed
If two implants were they done at the same time
At what age was the operation performed
How long after diagnosis of hearing loss was the operation performed
How long after diagnosis of EVA was the operation performed
Part 7 - Vertigo
Has the patient ever had balance problems or vertigo
If so how frequently
How severe
Are there triggering activities
At what age was the first episode
How long after diagnosis did vertigo occur
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None