Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?

Study Overview
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Brief Summary
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The purpose of this study is to evaluate standard of care exercise education alone or in combination with a wearable physical activity tracker in people with epilepsy (PWE) to determine the most effective way to increase physical activity and measure impact on depression, anxiety, quality of life, sleep, and seizure frequency.

Official Title
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Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Activity Tracker Group
* Behavioral: Standard of Care Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient of the Texas Comprehensive Epilepsy Program at UTHealth-McGovern Medical School diagnosis of epilepsy be able to provide consent in English complete surveys independently be able to sync Fitbit data Exclusion Criteria: currently using a wearable physical activity tracker prior to enrollment pregnant or planning to become pregnant during the study duration planning to undergo epilepsy surgery during the study duration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Behavioral: Activity Tracker Group<br>* In addition to the standard of care exercise education, participants in the activity tracker group will be provided a Fitbit physical activity tracker at no cost to the participants. They will be asked to download the Fitbit application (app) to their personal smartphone device to allow them to see their own data collected by the Fitbit. They will also be asked to download the Stridekick app for the purpose of sharing their activity tracker data electronically with the study team and having the opportunity to participate in fitness challenges through the app. App accounts will be created by the participants with usernames that do not contain the participant's identifiable personal information. Optional fitness challenges will be created once per month by the study investigators, and participants will also receive a weekly message of encouragement from the study team.<br>|
| Active Comparator: Control Group<br> | Behavioral: Standard of Care Group<br>* Participants will receive standard of care exercise education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of steps taken by participant |  | 3 months after enrollment | 
| Total distance traveled by participant |  | 3 months after enrollment | 
| Total time participant is active | measured in minutes | 3 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9) | this is scored form 0-27 with a higher number indicating higher severity | Baseline | 
| Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9) | this is scored form 0-27 with a higher number indicating higher severity | end of study (3 months after enrollment) | 
| Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7) | The GAD-7 score ranges form 0 (minimal anxiety) to 21 (severe anxiety) | Baseline | 
| Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7) | The GAD-7 score ranges form 0 (minimal anxiety) to 21 (severe anxiety) | end of study (3 months after enrollment) | 
| Sleep as measures by the Epworth Sleepiness Scale (ESS) | The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing) | Baseline | 
| Sleep as measures by the Epworth Sleepiness Scale (ESS) | The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing) | end of study (3 months after enrollment) | 
| Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey | The range of total scores for the QOLIE-10-P survey is 1 to 5, with 1 indicating a better outcome. | Baseline | 
| Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey | The range of total scores for the QOLIE-10-P survey is 1 to 5, with 1 indicating a better outcome. | end of study (3 months after enrollment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, exercise, activity tracker