NCT04357912CompletedNot Applicable
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
The University of Texas Health Science Center, Houston1 site in 1 country80 target enrollmentStarted: June 16, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of steps taken by participant
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
Active Comparator
Intervention: Standard of Care Group (Behavioral)
Experimental group
Experimental
Intervention: Activity Tracker Group (Behavioral)
Outcomes
Primary Outcomes
Number of steps taken by participant
Time Frame: 3 months after enrollment
Total time participant is active
Time Frame: 3 months after enrollment
measured in minutes
Total distance traveled by participant
Time Frame: 3 months after enrollment
Secondary Outcomes
- Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey(end of study (3 months after enrollment))
- Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)(end of study (3 months after enrollment))
- Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)(end of study (3 months after enrollment))
- Sleep as measures by the Epworth Sleepiness Scale (ESS)(end of study (3 months after enrollment))
- Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)(Baseline)
- Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)(Baseline)
- Sleep as measures by the Epworth Sleepiness Scale (ESS)(Baseline)
- Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey(Baseline)
Investigators
Katherine Marie Johns Harris
Clinical Fellow
The University of Texas Health Science Center, Houston
Study Sites (1)
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