Drug Resistant EpilepsyNCT05928598
Goals for Epilepsy Clinic Visits Trial
A study testing Survey questionnaires, Epilepsy Visit Planner and Questionnaires for Providers in people with Drug Resistant Epilepsy, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- Survey questionnaires, Epilepsy Visit Planner and Questionnaires for Providers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to 20 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with drug-resistant epilepsy
- Participants receiving care through the Epilepsy clinics at the University of Michigan
- -University of Michigan epilepsy providers
Who cannot join
- <18 years old
- Non-English speaking
- Do not clearly have drug-resistant epilepsy
- Moderate-to-severe cognitive impairment that precludes study questionnaire completion
- -Not University of Michigan epilepsy providers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug-Resistant Epilepsy (DRE) Goals for Epilepsy Clinical Visits mHealth Epilepsy Visit Planner 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:
Read more
- 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
- Being tested
- Survey questionnaires, Epilepsy Visit Planner, Questionnaires for Providers
- Keywords
- Survey, Quality of life, Communication tool, Patient-provider communication
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey questionnairesBehavioural
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 PlannerBehavioural
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 ProvidersBehavioural
Providers will be asked to complete a survey after the clinic visit for the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Standard care arm - patient participants | Other | This group will be enrolled first. Receives: Behavioral: Survey questionnaires |
| Intervention arm (Epilepsy Visit Planner) - patient participants | Experimental | This group will be enrolled after the standard care arm enrollment is completed. Receives: Behavioral: Survey questionnaires; Behavioral: Epilepsy Visit Planner |
| Intervention arm (Epilepsy Visit Planner) - provider participants | Other | Epilepsy providers will be recruited from the University of Michigan (approximately 10 providers). Receives: Behavioral: Questionnaires for Providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (4)
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.
Measured: Baseline
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).
Measured: 3 months after baseline visit
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.
Measured: Baseline - intervention arm only
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.
Measured: Baseline - intervention arm only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start27 Sep 2023
- Primary completion22 Jul 2026
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Enrollment for the trial will include 76 participants for the standard care arm and will include 76 participants for the intervention arm (who will receive the Epilepsy Visit Planner). The study team will enroll for the standard arm and then for the intervention arm for an approximate total of 152 participants. Additionally, approximately 10 providers will be enrolled.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Chloe Hill, University of Michigan
- Investigators
- Chloe Hill, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928598
- Sponsor's protocol ID
- HUM00231921
- Other IDs
- K23NS126495-02
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No