Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 22, 2020
CompletedStudy Start
First participant enrolled
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2022
CompletedDecember 5, 2023
December 1, 2023
2.2 years
April 20, 2020
December 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
Baseline
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
end of study (3 months after enrollment)
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
Baseline
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
end of study (3 months after enrollment)
Sleep as measures by the Epworth Sleepiness Scale (ESS)
Baseline
- +3 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALControl Group
ACTIVE COMPARATORInterventions
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.
Participants will receive standard of care exercise education.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Harris, MD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Fellow
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 22, 2020
Study Start
June 16, 2020
Primary Completion
September 2, 2022
Study Completion
September 2, 2022
Last Updated
December 5, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share