First Episode PsychosisNCT03196128
Early Intervention Psychosis Communication and Engagement Trial
A study testing Digital communication and Non digital in people with First Episode Psychosis, run by South London and Maudsley NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will examine whether or not the use of digital communication methods (text messages and emails) improves patient engagement with Early Intervention Psychosis (EIP) Services, compared to standard communication methods (letters and telephone calls). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- Digital communication and Non digital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jul 2017to 30 Jan 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First Episode Psychosis under the care of Early Intervention Psychosis Team Community Mental Health Team.
- Aged 18 - 65
- Fluent in the English language
- In first six months of service
- Has a mobile phone and access to the internet/email
Who cannot join
- Currently an inpatient in hospital
- Nearing discharge from EIP services
- Is not fluent in the English Language
- In acute crisis at the time of participant recruitment
- Does not have a mobile phone or access to the internet/email
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Christina Clark
London, SE11 5DL
Christina Clark, 02032287266, christina.clark@slam.nhs.uk
Eduardo Iacoponi, 02032287200, eduardo.iacoponi@slam.nhs.uk
About this study
Official title: Digital Media Versus Standard Method of Communication to Examine Engagement of Patients in Community Early Intervention Psychosis (EIP) Services
This study will examine whether or not the use of digital communication methods (text messages and emails) improves patient engagement with Early Intervention Psychosis (EIP) Services, compared to standard communication methods (letters and telephone calls).
One of the biggest challenges of psychiatric services is patient disengagement. People with psychosis, are often difficult to engage in community based mental health services (CMHTs). Patient's who disengage from psychiatric care often have higher social care needs, are often more unwell and are more likely to be detained under the Mental Health Act compared to those who engage. It is important to examine the reasons for this for both research and clinical reasons to establish the effectiveness of the service to its users. Importance must be placed on the clinician's perspective of the engagement; the patient's perspective is vital.
Read more
This study is a pilot two-arm pragmatic Randomised Control Trial to examine the feasibility of assessing engagement of EIP services through different communication methods. Patients and care-coordinators will use self-reported scales to measure engagement to determine whether this improves through the use of different communication methods.
Patients will be asked to consent to being randomly allocated to one of two groups:
(i.) Receive letters, phone calls and voicemail's from their care coordinator for standard appointments.
OR
(ii.) Receive text messages and emails from their care-coordinator for standard appointments.
Patients eligible for this study will be in their first six months of care under an EIP CMHT and who have consented to take part. They will be aged 18-35, not a hospital inpatient, have access to the Internet, a mobile phone and who are fluent in the English language.
Care-coordinators will assess the feasibility and acceptability of the design and procedures and determine an effective sample size calculation for a future large scale pragmatic Randomised Controlled Trial.
Read the detailed description
Participants (patients and care-coordinators):
Instruments:
Patients:
SOLES (Singh O'Brien Level of Engagement Scale, O'Brien et al 2009). (Appendix 1) This self-reporting scale is designed to measure the level of engagement in people with psychosis. It contains 16 questions covering various aspects of engagement, each question scored in a scale ranging from 0-10. This scale takes about 8-10 minutes to be completed.
Care Coordinators:
SES (Service Engagement Scale, Tait et al 2002). (Appendix 2) The SES is a scale completed by clinicians to assess their perceived level of engagement of patients under their care. It is a 14-question scale covering the same areas as the SOLES. The scale taken about 4-6 minutes to be completed.
Care Coordinator Feasibility Questionnaire:
It would also be of interest to collect feedback from care coordinators about the ease of use of the procedure along with the relevance and acceptability. This will be done through the use of a self reporting scale of how feasible the intervention delivery was. (Appendix 3)
Interventions:
When arranging appointments or having any other communication outside face-to-face meetings, care coordinators participating in this study will be expected to contact their patients in two distinct ways:
(i) 20 patients will receive Standard contact: this will happen by means of letters, telephone call and voicemail's only. Care co-ordinators already have trust mobile phones that they can use.
(ii) 20 patients will receive Digital media contact: only text messages and e-mails will be used to contact patients. Care coordinators will also be provided with i-pads (funded by the British Research Council so that they can do this when also outside of clinic).
Both types of contact will be made explicit for care coordinators at the beginning of the study, with frequent reminders occurring during the period of data collection. Care coordinators will have immediate access to written information about each of the interventions through participant information and consent forms provided (appendix 5).
Design:
A two-arm pragmatic pilot Randomised Controlled Trial. will be conducted comparing the digital media contact methods with standard contact methods and will assess the potential for progressing into a full pragmatic Randomised Controlled Trial. The co-primary outcome measures are to determine whether engagement with care coordinator/services improves through the use of digital media communication compared to standard methods of communication using The Singh O'Brien Level of Engagement Scales (SOLES)(O'Brien et al 2009) (SOLES) and The Service Engagement Scale (SES) (Tait et al 2002). These are self rating scales which will be completed both pre and post intervention to examine whether or not there has been an increase in engagement. Success of the study will be measured by an increase of scores in the scales to determine whether or not increased engagement was achieved.
Procedures:
Consecutive patients accepted for care under EIP teams will be asked to consent to participate in this study. If they consent, they will be allocated to one of two groups: either the Standard group or the Digital Media group. It is expected that each group will have approximately 20 patients. Care coordinator's will also be asked to consent to participate in the study and will be briefed by chief investigator on procedures.
Two months after intake into the study, patients and care coordinators will complete their respective engagement questionnaires. The level of engagement of each group, as measured by the instruments, will be used to analyse and compare the impact of the interventions.
- Conditions
- First Episode Psychosis
- Being tested
- Digital communication, Non digital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital communicationOther
Communicating with patients via email and text message.
Non digitalOther
Communicating with patients via telephone and written appointment letters.
| Study group | Role | What they receive |
|---|---|---|
| Digital | Active comparator | Not described Receives: Other: Digital communication |
| Non Digital | Active comparator | Not described Receives: Other: Non digital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Singh O'Brien Level of Engagement Scale
Self reporting scale designed to measure the level of engagement in people with psychosis. It contains 16 questions covering various aspects of engagement, each question scored in a scale ranging from 0-10.
Measured: Average completion time - 8-10 minutes.
Service Engagement Scale
A scale completed by clinicians to assess their perceived level of engagement of patients under their care. It is a 14 - question scale covering the same areas as the SOLES.
Measured: Average completion time: 4- 6 minutes.
Secondary outcomes (1)
Care Coordinator Feasibility Questionnaire
Self reporting scale.
Measured: Average completion Time: 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start18 Jul 2017
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode PsychosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South London and Maudsley NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Clark, South London and Maudsley NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196128
- Sponsor's protocol ID
- 17/EM/0093
- Status last verified
- Oct 2017
- First submitted
- 20 Jun 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Media Versus Standard Method of Communication to Examine Engagement of Patients in Community Early Intervention Psychosis (EIP) Services
- ClinicalTrials.gov ID
- NCT03196128
- Acronym / sponsor ID
- 17/EM/0093
- Conditions
- First Episode Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South London and Maudsley NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Jan 2018 (estimated)
- First posted
- 22 Jun 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 examine whether or not the use of digital communication methods (text messages and emails) improves patient engagement with Early Intervention Psychosis (EIP) Services, compared to standard communication methods (letters and telephone calls).
One of the biggest challenges of psychiatric services is patient disengagement. People with psychosis, are often difficult to engage in community based mental health services (CMHTs). Patient's who disengage from psychiatric care often have higher social care needs, are often more unwell and are more likely to be detained under the Mental Health Act compared to those who engage. It is important to examine the reasons for this for both research and clinical reasons to establish the effectiveness of the service to its users. Importance must be placed on the clinician's perspective of the engagement; the patient's perspective is vital.
This study is a pilot two-arm pragmatic Randomised Control Trial to examine the feasibility of assessing engagement of EIP services through different communication methods. Patients and care-coordinators will use self-reported scales to measure engagement to determine whether this improves through the use of different communication methods.
Patients will be asked to consent to being randomly allocated to one of two groups:
(i.) Receive letters, phone calls and voicemail's from their care coordinator for standard appointments.
OR
(ii.) Receive text messages and emails from their care-coordinator for standard appointments.
Patients eligible for this study will be in their first six months of care under an EIP CMHT and who have consented to take part. They will be aged 18-35, not a hospital inpatient, have access to the Internet, a mobile phone and who are fluent in the English language.
Care-coordinators will assess the feasibility and acceptability of the design and procedures and determine an effective sample size calculation for a future large scale pragmatic Randomised Controlled Trial.
Detailed description
Participants (patients and care-coordinators):
Instruments:
Patients:
SOLES (Singh O'Brien Level of Engagement Scale, O'Brien et al 2009). (Appendix 1) This self-reporting scale is designed to measure the level of engagement in people with psychosis. It contains 16 questions covering various aspects of engagement, each question scored in a scale ranging from 0-10. This scale takes about 8-10 minutes to be completed.
Care Coordinators:
SES (Service Engagement Scale, Tait et al 2002). (Appendix 2) The SES is a scale completed by clinicians to assess their perceived level of engagement of patients under their care. It is a 14-question scale covering the same areas as the SOLES. The scale taken about 4-6 minutes to be completed.
Care Coordinator Feasibility Questionnaire:
It would also be of interest to collect feedback from care coordinators about the ease of use of the procedure along with the relevance and acceptability. This will be done through the use of a self reporting scale of how feasible the intervention delivery was. (Appendix 3)
Interventions:
When arranging appointments or having any other communication outside face-to-face meetings, care coordinators participating in this study will be expected to contact their patients in two distinct ways:
(i) 20 patients will receive Standard contact: this will happen by means of letters, telephone call and voicemail's only. Care co-ordinators already have trust mobile phones that they can use.
(ii) 20 patients will receive Digital media contact: only text messages and e-mails will be used to contact patients. Care coordinators will also be provided with i-pads (funded by the British Research Council so that they can do this when also outside of clinic).
Both types of contact will be made explicit for care coordinators at the beginning of the study, with frequent reminders occurring during the period of data collection. Care coordinators will have immediate access to written information about each of the interventions through participant information and consent forms provided (appendix 5).
Design:
A two-arm pragmatic pilot Randomised Controlled Trial. will be conducted comparing the digital media contact methods with standard contact methods and will assess the potential for progressing into a full pragmatic Randomised Controlled Trial. The co-primary outcome measures are to determine whether engagement with care coordinator/services improves through the use of digital media communication compared to standard methods of communication using The Singh O'Brien Level of Engagement Scales (SOLES)(O'Brien et al 2009) (SOLES) and The Service Engagement Scale (SES) (Tait et al 2002). These are self rating scales which will be completed both pre and post intervention to examine whether or not there has been an increase in engagement. Success of the study will be measured by an increase of scores in the scales to determine whether or not increased engagement was achieved.
Procedures:
Consecutive patients accepted for care under EIP teams will be asked to consent to participate in this study. If they consent, they will be allocated to one of two groups: either the Standard group or the Digital Media group. It is expected that each group will have approximately 20 patients. Care coordinator's will also be asked to consent to participate in the study and will be briefed by chief investigator on procedures.
Two months after intake into the study, patients and care coordinators will complete their respective engagement questionnaires. The level of engagement of each group, as measured by the instruments, will be used to analyse and compare the impact of the interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital | Active comparator | Other: Digital communication |
| Non Digital | Active comparator | Other: Non digital |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First Episode Psychosis under the care of Early Intervention Psychosis Team Community Mental Health Team.
- Aged 18 - 65
- Fluent in the English language
- In first six months of service
- Has a mobile phone and access to the internet/email
Key exclusion criteria (5 listed)
- Currently an inpatient in hospital
- Nearing discharge from EIP services
- Is not fluent in the English Language
- In acute crisis at the time of participant recruitment
- Does not have a mobile phone or access to the internet/email
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 |
|---|---|---|
| Digital communicationCommunicating with patients via email and text message. | Other | Digital |
| Non digitalCommunicating with patients via telephone and written appointment letters. | Other | Non Digital |
Primary outcome
Singh O'Brien Level of Engagement Scale
Time frame: Average completion time - 8-10 minutes.
Self reporting scale designed to measure the level of engagement in people with psychosis. It contains 16 questions covering various aspects of engagement, each question scored in a scale ranging from 0-10.
Service Engagement Scale
Time frame: Average completion time: 4- 6 minutes.
A scale completed by clinicians to assess their perceived level of engagement of patients under their care. It is a 14 - question scale covering the same areas as the SOLES.
1 secondary outcome
Care Coordinator Feasibility Questionnaire
Time frame: Average completion Time: 10 minutes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital communication and Non digital in people with First Episode Psychosis, run by South London and Maudsley NHS Foundation Trust at 1 site 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Singh O'Brien Level of Engagement Scale (time frame: Average completion time - 8-10 minutes.). The study lists 2 primary outcomes in all. 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 17 Oct 2017.