The Efficacy of Using a Smartphone App to Support Shared Decision Making in People With a Diagnosis of Schizophrenia
Condition: Schizophrenia, Schizotypal and Delusional Disorders
MeSH terms: Schizophrenia; Schizophrenia, Paranoid
Study type: Interventional

Summary: 
      This study investigates the effects of using a smartphone app to support shared decision
      making (SDM) for people with schizophrenia-spectrum disorders in an outpatient treatment
      setting. Patients are randomized to specialized early intervention treatment with the
      Momentum app or without the app. The primary objective is to investigate the effect of the
      app on patient activation 6 months after baseline. Secondary outcomes are positive and
      negative symptoms, level of functioning; working alliance; self-efficacy; treatment
      satisfaction; hope; level of SDM; and perceived efficacy in patient-provider interaction.
      Explorative outcomes are self-perceived usefulness of the Momentum app.
    

Detailed description: 
      Background:

      Shared decision making (SDM) may be associated with positive health outcomes for the patient.
      While practitioners provide a professional expertise with information on the diagnosis,
      course of the illness, treatment options and potential side effects, patients are experts on
      their own needs, treatment preferences and goals. In mental healthcare, SDM have been
      assessed as a promising treatment intervention to promote patient involvement and clinical
      guidelines advocate the use of SDM as a patient-centered mental health care and a mean to
      increase patient empowerment. Although SDM today seems to be a preferred model for clinical
      decision-making for both patients and providers in mental health, patients indicate that they
      are not involved as much as they want to be in their treatment. Studies on SDM interventions
      for people with mental health issues are somewhat sparse and due to a small number of RCT
      studies, the evidence on SDM in mental health has been concluded as encouraging but
      inconclusive.

      Based on recent research, a digital healthcare solution which links patients and providers
      together could assist in providing support and potentially promote SDM. Findings from
      existing randomized controlled trials suggest that electronic aids to support SDM are a
      promising mean to engage patients in their mental health treatment. Recent systematic reviews
      do, however, highlight a need for more evidence-based research on the efficacy and
      effectiveness of mental health apps.

      Intervention:

      Momentum is a smartphone app, developed to support people with schizophrenia-spectrum
      disorders to prepare for treatment consultations while becoming more involved in treatment
      decisions. The app was developed in the period of 2013-2014 to support SDM in the Mental
      Health Services of the Capital Region of Denmark in a process of co-creation. Afterwards, the
      app was tested by 116 mental health professionals and 78 patients from three different mental
      health treatment sites: community of mental health, inpatient- and outpatient treatment
      sites. The app has since then been optimized based on the feedback received from the study
      participants.

      Aim:

      The purpose of this trial is to investigate the effects of the smartphone app Momentum for
      people with a diagnosis of schizophrenia, schizotypal or delusional disorders within
      outpatient treatment settings in a randomized design. Our main hypothesis is that patients
      using the Momentum app in combination with receiving specialized early intervention treatment
      (i.e. treatment as usual (TAU)), compared to patients only receiving TAU, will show greater
      improvements in patient activation, 6 months after baseline (primary outcome). Our secondary
      hypothesis is that patients using the Momentum app in combination with receiving TAU,
      compared to patients only receiving TAU, will show greater improvements regarding
      self-perceived level of SDM; self-efficacy; the therapeutic alliance; hope and optimism;
      satisfaction with treatment; patient's confidence in communicating preferences and concerns
      to their provider; severity of symptoms and; level of functioning (secondary outcomes).
      Lastly, the investigators hypothesize that there is a correlation between the effects of
      using the Momentum app and self-reported usefulness of the Momentum app and/or app usage
      (user sessions per day, screen views per day, screens per session, session duration and
      session instances, user retention) (explorative outcomes).
    

Intervention name(s): Momentum app
Intervention type(s): Device
Intervention description(s): The Momentum system consists of a smartphone app (for the patient) and a web portal (for the provider). Information entered in the app by the patient will automatically be transferred to the web portal for the provider to see. While one goal of the system is to support SDM, the Momentum app is not a classic decision aid focusing on finding a choice to a one-off treatment decision. Instead, the Momentum app is an aid to support some of the underlying elements behind SDM such as collaboration with one's provider, awareness and eliciting of one's needs, preferences and values.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two-arm, observer-blinded, parallel group randomised controlled superiority trial will be used for this intervention. Participants will be placed in one of two groups: Intervention group: treatment as usual (TAU) together with the Momentum app or (2) Control group: TAU without the Momentum app.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Shared decision making; Patient activation; Schizophrenia; First-episode psychosis; mHealth; Randomized clinical trial