Measure of Engagement of Epilepsy Patients in Messaging G... | NCT03076645

Studies
Measure of Engagement of Epilepsy Patients in Messaging Groups

NCT03076645

Sponsor

Royal Free Hospital NHS Foundation Trust

Status

Completed

Last Update Posted

Oct 12, 2017Actual

Enrollment

202Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

Facilitator support and education

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2016Actual

Primary Completion Date

Aug 10, 2017Actual

Completion Date

Aug 10, 2017Actual

First Submitted Date

Feb 2, 2017

First Submission Date that Met QC Criteria

Mar 6, 2017

First Posted Date

Mar 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2017

Last Update Posted Date

Oct 12, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abbas Hasan, Honorary Researcher, Royal Free Hospital NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Royal Free Hospital NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	The Experimental Group will be placed in a group using the matching algorithm. Facilitator support and education intervention	Behavioral: Facilitator support and education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Facilitator support and education	Behavioral	Group engaged with facilitator support and education	Experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Engagement	Average participant number of posts over time frame assessed by tracking number of participant entries	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Epilepsy self-management	Patient activation measure based on self-reported questionnaire	Change in Baseline to 6 weeks
Epilepsy medication adherence	Medication adherence based on self-reported questionnaire

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adina Nash	Royal Free London NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lewisham & Greenwich NHS Trust		Lewisham		SE4 2LA	United Kingdom
Barts and The London NHS Trust

IPD Sharing Statement Module

Plan to Share IPD

Description

No current resource to share individual participant data. Data will be destroyed per protocol after due course and completion of study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004522	Educational Status

Ancestor Terms

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics

Browse Leaves

Not provided

Browse Branches

Not provided