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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activity Tracker Group
Standard of Care Group
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epilepsy focused on measuring epilepsy, exercise, activity tracker

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Number of steps taken by participant
Total distance traveled by participant
Total time participant is active
measured in minutes

Secondary Outcome Measures

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
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
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)
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)
Sleep as measures by the Epworth Sleepiness Scale (ESS)
The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing)
Sleep as measures by the Epworth Sleepiness Scale (ESS)
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
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
The range of total scores for the QOLIE-10-P survey is 1 to 5, with 1 indicating a better outcome.

Full Information

First Posted
April 20, 2020
Last Updated
September 29, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Neurological Society Research Grant-2020
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1. Study Identification

Unique Protocol Identification Number
NCT04357912
Brief Title
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
Official Title
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2020 (Actual)
Primary Completion Date
June 16, 2022 (Anticipated)
Study Completion Date
June 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Neurological Society Research Grant-2020

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, exercise, activity tracker

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Activity Tracker Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care Group
Intervention Description
Participants will receive standard of care exercise education.
Primary Outcome Measure Information:
Title
Number of steps taken by participant
Time Frame
3 months after enrollment
Title
Total distance traveled by participant
Time Frame
3 months after enrollment
Title
Total time participant is active
Description
measured in minutes
Time Frame
3 months after enrollment
Secondary Outcome Measure Information:
Title
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
Description
this is scored form 0-27 with a higher number indicating higher severity
Time Frame
Baseline
Title
Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
Description
this is scored form 0-27 with a higher number indicating higher severity
Time Frame
end of study (3 months after enrollment)
Title
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
Description
The GAD-7 score ranges form 0 (minimal anxiety) to 21 (severe anxiety)
Time Frame
Baseline
Title
Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
Description
The GAD-7 score ranges form 0 (minimal anxiety) to 21 (severe anxiety)
Time Frame
end of study (3 months after enrollment)
Title
Sleep as measures by the Epworth Sleepiness Scale (ESS)
Description
The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing)
Time Frame
Baseline
Title
Sleep as measures by the Epworth Sleepiness Scale (ESS)
Description
The ESS scale ranges form 0 (would never dose) to 3 (high chance of dozing)
Time Frame
end of study (3 months after enrollment)
Title
Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey
Description
The range of total scores for the QOLIE-10-P survey is 1 to 5, with 1 indicating a better outcome.
Time Frame
Baseline
Title
Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey
Description
The range of total scores for the QOLIE-10-P survey is 1 to 5, with 1 indicating a better outcome.
Time Frame
end of study (3 months after enrollment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Harris, MD
Phone
(832) 325-7071
Email
Katherine.M.Johns@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Coulter
Phone
(832) 325-7071
Email
Andrew.Coulter@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Harris, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Harris, MD
Phone
832-325-7071
Email
Katherine.M.Johns@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Andrew Coulter
Phone
(832) 325-7071
Email
Andrew.Coulter@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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