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NCT Number: NCT05928598

Goals for Epilepsy Clinic Visits Trial

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.

Recruiting

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Key information

Conditions

Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Chloe Hill, MD

PRINCIPAL_INVESTIGATOR

Queen Bolden

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey questionnaires

Behavioral

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.

Epilepsy Visit Planner

Behavioral

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.

Questionnaires for Providers

Behavioral

Providers will be asked to complete a survey after the clinic visit for the intervention group.

Primary outcomes

  1. Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms

    Time frame: Baseline

    This is a 10-item measure with Likert scale (range 1-5 for each response) with a score range of 10-50 (higher score indicating higher perceived efficacy in communicating with providers).

Secondary outcomes

  1. Perceived Involvement in Care (PICS), difference in mean score between trial arms

    Time frame: Baseline

    This is a 13-item measure with binary agree/disagree responses (0 points for disagree and 1 point for agree) and higher scores reflecting a greater degree of perceived patient activity and involvement.

  2. Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms

    Time frame: 3 months after baseline visit

    This is a 10-item measure with Likert scale (range 1-5 for each response) with a score range of 10-50 (lower score indicates better health outcome).

  3. Feasibility, assessed in intervention arm

    Time frame: Baseline - intervention arm only

    Three questions will be asked regarding if the Planner was completed, if the Planner was shared during the visit, and how the Planner impacted visit length. Both patient participants and provider participants will complete these questions.

  4. Acceptability of Intervention Measure, assessed in intervention arm

    Time frame: Baseline - intervention arm only

    There are 4 questions that will be completed by the patient participants and provider participants that evaluate the acceptability of the intervention. The question responses have a Likert scale from 1(completely disagree) to 5 (completely agree). There is a range from 5-25 with a higher score indicating a higher acceptability of the intervention tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Queen Bolden

CONTACT

[email protected]

734-615-5495

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 3, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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