Baseline assessment and outcome measures
| Measure | Definition | Data source |
| Baseline assessment | ||
| Sociodemographic and clinical characteristics | Variables such as years of evolution, past and current treatment and comorbidities will be collected. | Patient interview at baseline |
| Primary outcomes | ||
| Willingness to enrol | The proportion of patients approached about the study that proceed to the consent stage. | Protocol database |
| Dropout attrition | The proportion of participants that fails to complete the study. | Protocol database |
| Non-usage attrition | The proportion of participants that does not drop out (eg, who are still completing the follow-up), but who stop using the m-RESIST tools (smartwatch, app). | Protocol database |
| Compliance | Variables such as logins, time online and questionnaires completed will be collected. | Protocol database |
| Acceptability | TAM. | Patient/caregiver interview at the end of study |
| Usability | User Experience Questionnaire. Interval Question. | Patient/caregiver/clinician interview throughout the study |
| Satisfaction | CSQ-8. | Patient/caregiver interview at the end of study |
| Secondary outcomes | ||
| Severity of symptoms | PANSS, CDS. | Patient interview at baseline and at the end of study |
| CGI-SCH. | Patient interview throughout the duration of the study | |
| Insight | SUMD. | Patient interview at baseline and at the end of study |
| Adherence | ARMS. | |
| Functionality | GAF, SFS. | |
| Perceived quality of life | EQ-5D-5L. | |
| Economic and organisational outcomes | Questionnaires with open ad-hoc questions form and semistructured interviews. | Central hospital database queried at 3 months before recruitment and at the end of the study |
| Safety | The presence of serious and non-serious adverse events, defined as any clinical change or illness reported during the study, will be monitored in every clinical visit. | Patient interview throughout the duration of the study |
ARMS, Adherence to Refills and Medications Scale; CDS, Calgary Depression Scale; CGI-SCH, Clinical Global Impression-Schizophrenia; CSQ-8, Client Satisfaction Questionnaire 8; EQ-5D-5L, EuroQol 5 dimensions 5 levels questionnaire; GAF, Global Assessment of Functioning; m-RESIST, mobile therapeutic attention for treatment-resistant schizophrenia; PANSS, Positive and Negative Syndrome Scale; SFS, Social Functioning Scale; SUMD, Scale Unawareness Mental Disorders; TAM, Technology Acceptance Model scale.