Goals for Epilepsy Clinic Visits Trial

Официальное название

Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits mHealth Epilepsy Visit Planner Trial

Обзор

The purpose of this project is to conduct a trial to assess whether patients that receive a tablet-based waiting room priority communication tool (the "Epilepsy Visit Planner") have improved outcomes compared to patients that do not receive the tool. The project's hypotheses are: * Patients that receive the Epilepsy Visit Planner will have improved patient-provider communication compared to the non-planner group. * Patients that receive the Epilepsy Visit Planner will have improved quality of life scores. * The Epilepsy Visit Planner will score highly on process measures of feasibility and acceptability, demonstrating suitability for future larger scale study. Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.

Вмешательства

• Поведенческое Survey questionnaires
  Participants will be enrolled before a scheduled clinic appointment. Following the clinic visit, the research staff will ask the patient to complete questionnaires electronically (or by phone if patient prefers) within three days after the baseline clinic visit and then at three months following this visit. Additionally, some data will be obtained from the participant's medical record.
• Поведенческое Epilepsy Visit Planner
  Participants will be identified before a scheduled clinic appointment. Prior to the clinic visit (at the site) the participants will meet with a research staff to obtain written informed consent and then present the Epilepsy Visit Planner to the patient. Participants will be encouraged to use the Planner and share the Planner's output with the provider during the clinic visit. In some cases, there could be an option for the participants to consent prior to the visit and have a virtual presentati
• Поведенческое Questionnaires for Providers
  Providers will be asked to complete a survey after the clinic visit for the intervention group.

Первичные конечные точки

• Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms [Срок оценки: Baseline]

Вторичные конечные точки (4)

• Perceived Involvement in Care (PICS), difference in mean score between trial arms [Срок оценки: Baseline]
• Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms [Срок оценки: 3 months after baseline visit]
• Feasibility, assessed in intervention arm [Срок оценки: Baseline - intervention arm only]
• Acceptability of Intervention Measure, assessed in intervention arm [Срок оценки: Baseline - intervention arm only]

Критерии участия

Inclusion Criteria - Patient Participants:

• Adults with drug-resistant epilepsy
• Participants receiving care through the Epilepsy clinics at the University of Michigan

Exclusion Criteria - Patient Participants:

• <18 years old
• Non-English speaking
• Do not clearly have drug-resistant epilepsy
• Moderate-to-severe cognitive impairment that precludes study questionnaire completion

Inclusion Criteria - Provider Participants:

-University of Michigan epilepsy providers

Exclusion Criteria - Provider Participants:

-Not University of Michigan epilepsy providers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Michigan — Ann Arbor

Идентификаторы

NCT: NCT05928598 · HUM00231921 · K23NS126495-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗