Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06362161
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-08
Brief Title:
Establishment of an Interdisciplinary Functional Neurological Disorder FND Treatment Program and Development of a Clinical Care Pathway for FND
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Establishment of an Interdisciplinary Functional Neurological Disorder FND Treatment Program and Development of a Clinical Care Pathway for FND
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder FND at University of Alabama at Birmingham UAB and will involve psychiatry speech therapy physical therapy and occupational therapy The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes
Detailed Description:
Prospective Study Adult patients and pediatric patients and their parentguardian who are referred to the UAB functional neurological disorder FND clinical pathway will be screened for eligibility Overall 750 participants 250 adult patients 250 pediatric patients and their parentguardian will be enrolled in the prospective study
For patients for whom an FND inpatient consult has been requested the consulting psychologist will screen eligible participants For outpatient FND patients the psychiatry FND clinic scheduling coordinator will screen patients for eligibility Potential eligible participants will provide verbal consent during the screening phone call
Once verbal consent has been obtained participants will be given the pre-treatment survey questions via email for outpatient referrals via a tablet computer for inpatient consults These surveys will be different for adult FND patients children with FND and parentsguardians of children with FND each survey will contain the appropriate consentassent form Participants will complete the pre-treatment surveys once they sign the appropriate consentassent form
During each outpatient visit with a clinician patients will be administered the one-item Clinical Global Improvement Scale and asked about retrospective symptom frequency which will be entered directly into the electronic health record EHR If patients are seeing physical occupational or speech therapy PTOTSpeech the clinician will enter clinical measures directly into the EHR Following the course of FND treatment participants and parentsguardians where applicable will complete the post-survey questionnaires
Participants may be asked to provide full facial pictures andor videos before treatment and after treatment
Retrospective study EHR data of participants who recieved FND treatment at UAB FND clinical pathway from Jan 2020 to May 2023 will be collected retrospectively 500 records will be screened for potential inclusion in the study Overall data will be extracted from 350 patient records
The research team will utilize EHR entries to pull any clinical data related to FND treatment visits inpatient consults outpatient psychiatryPTOTSpeech This EHR data collection will be both retrospective and prospective and include all records related to FND treatment including neurology PTOTSpeech and psychiatry notes
The cost of participants standard medical care will be billed to them andor their insurance company in the usual manner Participants will not be paid for participation in the study
For patients for whom an FND inpatient consult has been requested the consulting psychologist will screen eligible participants For outpatient FND patients the psychiatry FND clinic scheduling coordinator will screen patients for eligibility Potential eligible participants will provide verbal consent during the screening phone call
Once verbal consent has been obtained participants will be given the pre-treatment survey questions via email for outpatient referrals via a tablet computer for inpatient consults These surveys will be different for adult FND patients children with FND and parentsguardians of children with FND each survey will contain the appropriate consentassent form Participants will complete the pre-treatment surveys once they sign the appropriate consentassent form
During each outpatient visit with a clinician patients will be administered the one-item Clinical Global Improvement Scale and asked about retrospective symptom frequency which will be entered directly into the electronic health record EHR If patients are seeing physical occupational or speech therapy PTOTSpeech the clinician will enter clinical measures directly into the EHR Following the course of FND treatment participants and parentsguardians where applicable will complete the post-survey questionnaires
Participants may be asked to provide full facial pictures andor videos before treatment and after treatment
Retrospective study EHR data of participants who recieved FND treatment at UAB FND clinical pathway from Jan 2020 to May 2023 will be collected retrospectively 500 records will be screened for potential inclusion in the study Overall data will be extracted from 350 patient records
The research team will utilize EHR entries to pull any clinical data related to FND treatment visits inpatient consults outpatient psychiatryPTOTSpeech This EHR data collection will be both retrospective and prospective and include all records related to FND treatment including neurology PTOTSpeech and psychiatry notes
The cost of participants standard medical care will be billed to them andor their insurance company in the usual manner Participants will not be paid for participation in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None