Clinical trial NCT06362161: Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND
Official title: Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Functional Neurological Disorder
Convulsion, Non-Epileptic
Functional Seizure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 1100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be referred to the interdisciplinary FND clinical pathway via UAB- or non-UAB clinicians and physicians. Individuals who are referred will be eligible to participate in the study.

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 parent/guardian 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 parent/guardian) 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 parents/guardians of children with FND; each survey will contain the appropriate consent/assent form. Participants will complete the pre-treatment surveys once they sign the appropriate consent/assent 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 (PT/OT/Speech), the clinician will enter clinical measures directly into the EHR. Following the course of FND treatment, participants and parents/guardians (where applicable) will complete the post-survey questionnaires.

Participants may be asked to provide full facial pictures and/or 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 psychiatry/PT/OT/Speech). This EHR data collection will be both retrospective and prospective, and include all records related to FND treatment, including neurology, PT/OT/Speech, and psychiatry notes.

The cost of participant's standard medical care will be billed to them and/or their insurance company in the usual manner. Participants will not be paid for participation in the study.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of FND
* Can read and write English fluently
* Referred to UAB outpatient treatment for FND in physical, occupational, or speech therapy
* Referred to UAB outpatient treatment for FND in psychiatry
* Referred to inpatient consult for FND at Children's of Alabama or UAB Hospital
* Parent/guardian willing to participate in the study with a pediatric patient

Exclusion Criteria:

* Unable to read or write English fluently

Primary outcomes:
measure: Patient Demographic Information
timeFrame: 4 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 months
measure: ASM 121 functional assessment definitions
timeFrame: 4 months
measure: SF-36 (subjective health and wellbeing)
timeFrame: 4 months
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 4 months
measure: Patient Health Questionnaire 15
timeFrame: 4 months
measure: Dizziness Handicap Inventory
timeFrame: 4 months
measure: Dizziness Symptom Profile
timeFrame: 4 months
measure: Adult Tic Questionnaire (ATQ)
timeFrame: 4 months
measure: Child Self-Report Tic Questionnaire
timeFrame: 4 months
measure: Parent Tic Questionnaire (PTQ)
timeFrame: 4 months
measure: Seizure Questionnaire
timeFrame: 4 months
measure: Level 2-Somatic Symptom report
timeFrame: 4 months
measure: Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: 4 months
measure: Functional Disability Inventory (FDI)
timeFrame: 4 months
measure: Impact on the Family Scale
timeFrame: 4 months
measure: Pediatric Quality of Life (Peds-QL)
timeFrame: 4 months
measure: Healthcare Utility Questionnaire
timeFrame: 4 months
measure: Assessment of control over symptoms
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Aaron Fobian, PhD
role: PRINCIPAL_INVESTIGATOR
References: