Goals for Epilepsy Clinic Visits Trial

Drug Resistant Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928598
• Other study ID #: HUM00231921
• Secondary ID: K23NS126495-01A1
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2023
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: Queen Bolden
• Phone: 734-615-5495
• Email: qmbolden[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: January 1, 2027
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Efficacy in Patient-Physician Interactions Questionnaire (PEPPI), difference in mean score between trial arms	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).	Baseline
Secondary	Perceived Involvement in Care (PICS), difference in mean score between trial arms	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.	Baseline
Secondary	Quality of Life in Epilepsy (QOLIE-10) inventory, difference in mean score between trial arms	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 months after baseline visit
Secondary	Feasibility, assessed in intervention arm	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.	Baseline - intervention arm only
Secondary	Acceptability of Intervention Measure, assessed in intervention arm	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.	Baseline - intervention arm only