NCT05928598

Goals for Epilepsy Clinic Visits Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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 presentation of the Planner. Following the clinic visit, the research staff will ask the participants 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.
BEHAVIORAL	Questionnaires for Providers	Providers will be asked to complete a survey after the clinic visit for the intervention group.

Timeline

• Start date: 2023-09-27
• Primary completion: 2026-09-01
• Completion: 2027-01-01
• First posted: 2023-07-03
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States