NCT03076645

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

10 months

First QC Date

February 2, 2017

Last Update Submit

October 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Engagement

    Average participant number of posts over time frame assessed by tracking number of participant entries

    6 weeks

Secondary Outcomes (3)

  • Epilepsy self-management

    Change in Baseline to 6 weeks

  • Epilepsy medication adherence

    Change in Baseline to 6 weeks

  • Epilepsy quality of life

    Change in Baseline to 6 weeks

Study Arms (1)

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

Group engaged with facilitator support and education

Experimental

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Lewisham & Greenwich NHS Trust

Lewisham, SE4 2LA, United Kingdom

Location

Barts and The London NHS Trust

London, E1 1BB, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

National Hospital for Neurology and Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Kent Community Health NHS Trust

Maidstone, ME15 7AT, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Adina Nash

    Royal Free London NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Researcher

Study Record Dates

First Submitted

February 2, 2017

First Posted

March 10, 2017

Study Start

October 1, 2016

Primary Completion

August 10, 2017

Study Completion

August 10, 2017

Last Updated

October 12, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

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

Locations