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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT04357912

Collaborator

Texas Neurological Society Research Grant-2020 (Other)

82

Enrollment

1

Location

2

Arms

24

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Behavioral: Activity Tracker Group Behavioral: Standard of Care Group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 16, 2020

Anticipated Primary Completion Date :

Jun 16, 2022

Anticipated Study Completion Date :

Jun 16, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Experimental group

Behavioral: Activity Tracker Group

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.

Active Comparator: Control Group

Behavioral: Standard of Care Group

Participants will receive standard of care exercise education.

Outcome Measures

Primary Outcome Measures

Number of steps taken by participant [3 months after enrollment]
Total distance traveled by participant [3 months after enrollment]
Total time participant is active [3 months after enrollment]
measured in minutes

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston
Texas Neurological Society Research Grant-2020

Investigators

Principal Investigator: Katherine Harris, MD, The University of Texas Health Science Center, Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katherine Marie Johns Harris, Clinical Fellow, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT04357912

Other Study ID Numbers:

HSC-MS-20-0173

First Posted:

Apr 22, 2020

Last Update Posted:

Sep 30, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

No

Plan to Share IPD:

No

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Keywords provided by Katherine Marie Johns Harris, Clinical Fellow, The University of Texas Health Science Center, Houston

activity tracker

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 30, 2021