The Momentum trial (NCT03554655), which began enrollment in January 2019 and is expected to end in April 2020, is investigating the hypothesis that patients with schizophrenia-spectrum disorders will become more active and engaged in their own treatment and shared decision-making (SDM) with healthcare providers through the use of a smartphone app developed by the Mental Health Services of the Capital Region of Denmark. According to an article published in BMC Psychiatry, investigators hope to integrate the app with existing information technology systems in the future in order to assess long-term efficacy.
When both patient and practitioner are actively involved in treatment through SDM, improvements are seen in outcomes (not just in perceptions) regarding treatment decisions, and in patients’ knowledge about their disease and in personal recovery. Despite the advantages that persist regardless of the condition being treated, SDM occurs much more frequently in primary care than in mental health care, and electronic aids designed to support patient engagement with SDM could be an effective tool to improve outcomes.
This multicenter, two-arm, parallel-group, observer-blinded block, randomized controlled trial has been designed to assess the effects of using a smartphone app that promotes patient engagement and supports SDM for patients with schizophrenia. Two-hundred-sixty participants (130 per arm) between 18 and 35 diagnosed with schizophrenia or related psychotic disorders are currently being recruited from 5 outpatient treatment sites called OPUS in the Capital Region of Denmark. OPUS teams provide patients with specialized early intervention (SEI) treatment, and for the purposes of this study, treatment as usual (TAU) will be defined OPUS treatment, and the trial will compare outcomes for participants receiving TAU (control group) with participants receiving TAU who are also provided with a smartphone-based treatment aid to promote patient activation and support SDM in an outpatient setting (intervention group).
The trial will last 6 months, with data collection at 6 months, 3 months, and baseline, with the primary outcome of self-perceived participant activation, and the secondary outcomes of feeling prepared for SDM, working alliance, self-efficacy, positive and negative symptoms, treatment satisfaction, hope, level of functioning, and perceived efficacy in patient-provider interaction. Preferences of both healthcare providers and participants in clinical decision making will be assessed, as well as participants’ level of usage and perceived usefulness of the smartphone app.
If the Momentum trial confirms the hypothesis that patients with schizophrenia-spectrum disorders who are provided with this system will increase activation in treatment and engagement with SDM, the findings will provide evidence for the value of such tools to encourage patients with severe mental illness to participate in their own healthcare management, thereby improving treatment outcomes. “Overall, the study will provide more evidence to the further developing and implementation of electronic tools to support SDM in mental health care,” according to Momentum trial researchers. “Future enhancements will be to integrate the smartphone app with the existing IT systems and to investigate its efficacy long term [1 year or more] and in other mental healthcare settings.”