Идёт набор NCT06362161

Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND

— Наблюдательное Functional Neurological Disorder Convulsion, Non-Epileptic Functional Seizure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Functional Neurological Disorder, Convulsion, Non-Epileptic, Functional Seizure. Базовые параметры: 8 лет — 89 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Первичные конечные точки

Patient Demographic Information [Срок оценки: 4 months]
Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 4 months]
ASM 121 functional assessment definitions [Срок оценки: 4 months]
SF-36 (subjective health and wellbeing) [Срок оценки: 4 months]
Work and Social Adjustment Scale (WSAS) [Срок оценки: 4 months]
Patient Health Questionnaire 15 [Срок оценки: 4 months]
Dizziness Handicap Inventory [Срок оценки: 4 months]
Dizziness Symptom Profile [Срок оценки: 4 months]
Adult Tic Questionnaire (ATQ) [Срок оценки: 4 months]
Child Self-Report Tic Questionnaire [Срок оценки: 4 months]

Критерии участия

Критерии включения

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