Condition category
Mental and Behavioural Disorders
Date applied
17/04/2014
Date assigned
17/04/2014
Last edited
25/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We have developed and tested a new, responsive method which enables people with psychosis to monitor their symptoms. This led to the development of a smartphone application, known as ClinTouch, which collects and uploads symptom information securely to a central computer server several times daily.

Who can participate?
Adults who have been diagnosed with schizophrenia or other related mental disorders can take part.

What does the study involve?
Participants will be randomly allocated either to use the ClinTouch app for 12 weeks or to not use the app. The app beeps four times daily to prompt the user to respond to a simple set of symptom questions. This information is made available to a user's mental health team who can use it to tailor the support they provide (CareLoop). The computer server checks if the user is becoming unwell or if they are at increased risk of harming themselves and alerts the health team. Users may also personalise the look of the app and the way certain features work, as well as complete an accompanying personal daily diary. All participants will be followed up.

What are the possible benefits and risks of participating?
Participants who take part may benefit from using a new system which helps them to keep track of their mood and symptoms, and communicate these experiences with their mental health team.

Where is the study run from?
This study is being run by the University of Manchester and the Institute of Psychiatry at King's College, London, with the help of Manchester Mental Health and Social Care, and South London and Maudsley Trusts.

When is the study starting and how long is it expected to run for?
The study will start in May 2014 and lasts for one year.

Who is funding the study?
Medical Research Council (MRC) (UK).

Who is the main contact?
Dr Eve Applegate
eve.applegate@manchester.ac.uk

Trial website

http://www.clintouch.com

Contact information

Type

Scientific

Primary contact

Dr Eve Applegate

ORCID ID

Contact details

Institute of Brain
Behaviour & Mental Health
University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
eve.applegate@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16361

Study information

Scientific title

Proof of Concept (PoC) Feasibility Trial of ClinTouch-CareLoop Enhanced Management (CEM) versus Management As Usual (MAU) in people with psychosis

Acronym

Study hypothesis

An examination of the feasibility, utility, safety and effectiveness of the ClinTouch-CareLoop Enhanced Management (CEM) versus Management As Usual (MAU) will be undertaken. It is hypothesised that CEM will be feasible and acceptable to staff and patients. The effect of CEM on patient self-management, empowerment, clinical care, detection of Early Warning Signs (EWS) and targeting of treatment will also be examined.

Ethics approval

14/WM/0045; First MREC approval date 18/02/2014

Study design

Randomised; Interventional; Design type: Prevention, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health; Subtopic: Schizophrenia; Disease: Schizophrenia

Intervention

CareLoop Enhanced Management: Use of mobile phone app to monitor and manage existing and emerging depressive and psychotic symptoms with support from mental health workers.
Follow Up Length: 15 month(s); Study Entry : Single Randomisation only

80 service users with psychosis, deemed relapse prone, will be recruited in Manchester and London. 40 participants will be randomised to receive ClinTouch-CareLoop Enhanced Management (CEM) and 40 participants will receive Management As Usual (MAU). Randomisation will be performed by the Manchester Academic Health Sciences Centre (MAHSC) Trials Coordination Unit at the Christie Hospital via telephone according to an agreed allocation algorithm.

Participants randomised to receive CEM will use loaned handsets with the ClinTouch app installed. They will receive CareLoop enhanced support and management from mental health staff who have access to symptom information and EWS alerts via CareLoop for 12 weeks. Default ClinTouch settings will prompt and collect two datasets daily via four alerts. Each alert will contain 10 branching items that probe positive psychotic symptoms, anxiety and mood. All service users and mental health staff will receive training and technical support throughout. Those randomised to the MAU arm of the trial will not have access to ClinTouch or CareLoop enhanced support mechanisms.

A researcher will complete the following assessments with all service user participants at baseline, 6 and 12 weeks:

1. The Structured Clinical Interview-Positive and Negative Syndrome Scale, SCI-PANSS, (Kay et al., 1987)
2. The Calgary Depression Scale for schizophrenia, CDS (Addington et al., 1990)
3. The Global Assessment of Functioning, GAF (APA, 1994)
4. EQ-5D-5L (Euroqol group, 1990)
5. Empowerment Rating Scale (Rogers et al., 1997)
6. Economic Patient Questionnaire (EPQ)

The Early Warning Signs scale, EWS (Birchwood et al., 2000), will be administered at baseline and a quantitative feedback questionnaire will be given to service users in the CEM group at the end of the study to collate views on the usefulness of the technology.

A longitudinal qualitative evaluation will run alongside the trial using multiple qualitative methods comprising:
1. Semi-structured in-depth interviews with 20 professionals, 30 service users, and nominated carers at baseline and follow-up. The semi-structured interviews will explore perceived utility for service users, perceived impact on self-care and recovery, and the nature of interaction with team staff. Interviews with staff from the two trial sites will focus on their views, expectations and experiences of the CareLoop system within the broader contextual issues regarding the organisation and delivery of care.
2. Observation of how patients and staff adopt and use the system. Observational methods will focus on professional and client interactions and participants’ everyday use of technology. Observation will include attention to how the system fits into the everyday routines of management and care practices for clients and professionals.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. We will assess patient, staff and service-orientated outcomes via scrutiny of:
1.1. Adoption and use of the ClinTouch and CareLoop systems by service users and staff
1.2. Effective detection of relapse or deliberate self-harm
1.3. Responsive changes in clinical management
1.4. Changes in patient views on system preference, self-efficacy, empowerment and recovery.
2. Patient-centred objectives: the proportion of eligible service users consenting; the proportion continuing for 12 weeks; the number completing greater than 33% of datapoints; the proportion indicating they would continue for a longer period at exit
3. Team-centred objectives: how frequently CareLoop data is accessed; the number of times summary data is discussed with the service user.
4. The indicative efficacy endpoints for comparing CEM vs. MAU will be:
4.1. Episodes of early warning signs of relapse or deliberate self-harm correctly detected by CareLoop
4.2. User empowerment from semi-structured qualitative interviews and Empowerment Rating Scale (Rogers et al., 1997) measured at 0, 6 and 12 weeks
4.3. Retrospectively gathered service data: service user visits brought forward, medication changes, referrals to crisis and other services, inpatient admissions, transfer between services, and Emergency Department visits.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2014

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of schizophrenia or related psychotic disorders, meeting or having met the criteria for such a diagnosis
2. Aged 18 to 65 years
3. Able to provide written and witnessed informed consent; responsible medical officer will be consulted in case of uncertainly
4. Can read and write in English at a level sufficient to understand and complete study-related procedures
5. Not acutely unwell at point of study entry as defined by baseline PANSS total symptom subscale score of less than 110
6. Relapse prone as defined by one or more psychotic episodes requiring inpatient admission in past 2 years as judged from case records
Target Gender: Male & Female; Upper Age Limit 65 years ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

1. Diagnosis of bipolar disorder
2. Inpatient status
3. Unable or unwilling to give written informed consent
4. Unable to understand written materials relating to the study
5. PANSS total score of less than 70 or more than 110
6. Not relapse prone, as defined by fewer than one psychotic episodes requiring inpatient admission in past 2 years as judged from case records

Recruitment start date

01/05/2014

Recruitment end date

30/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Brain, Behaviour & Mental Health
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

Manchester Mental Health and Social Care Trust (UK)

Sponsor details

Rawnsley Building
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC); Grant Codes: MR/K015516/1

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes