EpilepsyNCT03076645
Measure of Engagement of Epilepsy Patients in Messaging Groups
A study testing Facilitator support and education in people with Epilepsy, run by Royal Free Hospital NHS Foundation Trust at 5 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Facilitator support and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 1 Oct 2016to 10 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Lewisham & Greenwich NHS Trust
Lewisham, SE4 2LA
Barts and The London NHS Trust
London, E1 1BB
Royal Free Hospital
London, NW3 2QG
National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
Kent Community Health NHS Trust
Maidstone, ME15 7AT
About this study
Official title: Measure of Engagement of Epilepsy Patients in Messaging Groups and Group Characteristics That Influence Engagement.
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
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Facilitator support and education
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitator support and educationBehavioural
Group engaged with facilitator support and education
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The Experimental Group will be placed in a group using the matching algorithm. Facilitator support and education intervention Receives: Behavioral: Facilitator support and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement
Average participant number of posts over time frame assessed by tracking number of participant entries
Measured: 6 weeks
Secondary outcomes (3)
Epilepsy self-management
Patient activation measure based on self-reported questionnaire
Measured: Change in Baseline to 6 weeks
Epilepsy medication adherence
Medication adherence based on self-reported questionnaire
Measured: Change in Baseline to 6 weeks
Epilepsy quality of life
Quality of life in epilepsy metric based on self-reported questionnaire
Measured: Change in Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start1 Oct 2016
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbas Hasan, Royal Free Hospital NHS Foundation Trust
- Investigators
- Adina Nash, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076645
- Sponsor's protocol ID
- 203594
- Status last verified
- Oct 2017
- First submitted
- 2 Feb 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No current resource to share individual participant data. Data will be destroyed per protocol after due course and completion of study
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure of Engagement of Epilepsy Patients in Messaging Groups and Group Characteristics That Influence Engagement.
- ClinicalTrials.gov ID
- NCT03076645
- Acronym / sponsor ID
- 203594
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Facilitator support and educationThe Experimental Group will be placed in a group using the matching algorithm. Facilitator support and education intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age, diagnosis of epilepsy, have access to a smartphone capable of running messaging application
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitator support and educationGroup engaged with facilitator support and education | Behavioural | Experimental |
Primary outcome
Engagement
Time frame: 6 weeks
Average participant number of posts over time frame assessed by tracking number of participant entries
3 secondary outcomes
Epilepsy self-management
Time frame: Change in Baseline to 6 weeks
Epilepsy medication adherence
Time frame: Change in Baseline to 6 weeks
Epilepsy quality of life
Time frame: Change in Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: No. No current resource to share individual participant data. Data will be destroyed per protocol after due course and completion of study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adina Nash principal investigator
Royal Free London NHS Foundation Trust
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitator support and education in people with Epilepsy, run by Royal Free Hospital NHS Foundation Trust at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2017.