Topic: Mental Health
Conditions
Interventions
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 L
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 receiv
Sponsors
Manchester Mental Health and Social Care Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed