Back to resultsMeasure of Engagement of Epilepsy Patients in Messaging Groups
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Facilitator support and education
Sponsored by
About this trial
This is an interventional supportive care trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application
Exclusion Criteria:
- A diagnosis of learning disability/difficulty, significant mental health conditions; those in care, bereaved, or prisoners. Any other vulnerable individuals (individuals unable to protect themselves against significant harm or exploitation)
Sites / Locations
- Lewisham & Greenwich NHS Trust
- Barts and The London NHS Trust
- Royal Free Hospital
- National Hospital for Neurology and Neurosurgery
- Kent Community Health NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
The Experimental Group will be placed in a group using the matching algorithm. Facilitator support and education intervention
Outcomes
Primary Outcome Measures
Engagement
Average participant number of posts over time frame assessed by tracking number of participant entries
Secondary Outcome Measures
Epilepsy self-management
Patient activation measure based on self-reported questionnaire
Epilepsy medication adherence
Medication adherence based on self-reported questionnaire
Epilepsy quality of life
Quality of life in epilepsy metric based on self-reported questionnaire
Full Information
NCT ID
NCT03076645
First Posted
February 2, 2017
Last Updated
October 11, 2017
Sponsor
Royal Free Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03076645
Brief Title
Measure of Engagement of Epilepsy Patients in Messaging Groups
Official Title
Measure of Engagement of Epilepsy Patients in Messaging Groups and Group Characteristics That Influence Engagement.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
August 10, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Free Hospital NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will measure the engagement of people with epilepsy in a mobile phone based messaging platform as well as understand if there is an impact on their self-management
Detailed Description
The primary purpose of this study is to assess a person with epilepsy's level of usage of a mobile messaging application for peer support. The secondary purpose is to understand what characteristics of their group drive different levels of usage and improvements in self-management.
Participants can participate as much or little as they want for a minimum of six weeks. Participants will complete an initial and a final questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
The Experimental Group will be placed in a group using the matching algorithm. Facilitator support and education intervention
Intervention Type
Behavioral
Intervention Name(s)
Facilitator support and education
Intervention Description
Group engaged with facilitator support and education
Primary Outcome Measure Information:
Title
Engagement
Description
Average participant number of posts over time frame assessed by tracking number of participant entries
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Epilepsy self-management
Description
Patient activation measure based on self-reported questionnaire
Time Frame
Change in Baseline to 6 weeks
Title
Epilepsy medication adherence
Description
Medication adherence based on self-reported questionnaire
Time Frame
Change in Baseline to 6 weeks
Title
Epilepsy quality of life
Description
Quality of life in epilepsy metric based on self-reported questionnaire
Time Frame
Change in Baseline to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application
Exclusion Criteria:
A diagnosis of learning disability/difficulty, significant mental health conditions; those in care, bereaved, or prisoners. Any other vulnerable individuals (individuals unable to protect themselves against significant harm or exploitation)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adina Nash
Organizational Affiliation
Royal Free London NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lewisham & Greenwich NHS Trust
City
Lewisham
ZIP/Postal Code
SE4 2LA
Country
United Kingdom
Facility Name
Barts and The London NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
National Hospital for Neurology and Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Kent Community Health NHS Trust
City
Maidstone
ZIP/Postal Code
ME15 7AT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No current resource to share individual participant data. Data will be destroyed per protocol after due course and completion of study
Learn more about this trial
Measure of Engagement of Epilepsy Patients in Messaging Groups
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