Clinical trial NCT03554655: The Efficacy of Using a Smartphone App to Support Shared Decision Making in People With a Diagnosis of Schizophrenia
Official title: The Momentum Trial: The Efficacy of Using a Smartphone Application to Support Shared Decision Making Through Patient Activation in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia, Schizotypal and Delusional Disorders
Keywords: Shared decision making
Patient activation
Schizophrenia
First-episode psychosis
mHealth
Randomized clinical trial
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: Odense Patient Data Explorative Network
First posted: 2018-06-13
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Adults of both sexes aged 18+
* A diagnosis of schizophrenia, schizotypal or delusional disorder (ICD-10 codes: F20-F29)
* The patient have received treatment for a maximum of 18 months at the start of the intervention from one of five participating OPUS centre in the Mental Health Services of the Capital Region of Denmark

Exclusion Criteria:

* Do not understand or speak Danish
* Unable to give written informed consent to participate in the trial at the described terms
* Are participating in other research studies involving OPUS treatment and an app
* Do not have daily access to a smartphone
* Are suffering of mental retardation or dementia (F. 70-F.79, F.00-F.03)

Primary outcomes:
measure: Change in patient activation measured with the Consumer Health Activation Index - Mental Health (CHAI-MH)
timeFrame: baseline, 3 months and end of intervention (6 months)
Secondary outcomes:
measure: Change in self-efficacy measured with the General Self-Efficacy scale (GSE)
timeFrame: baseline, 3 months and end of intervention (6 months)
measure: Change in preparedness for decision making measured with the scale Preparation for Decision Making (PrepDM)
timeFrame: baseline and 6 months
measure: Change in hope measured with the Adult State Hope Scale (ASH)
timeFrame: baseline, 3 months and end of intervention (6 months)
measure: Change in the efficacy of interactions measured with the scale Perceived Efficacy in Patient-Provider Interactions (PEPPI)
timeFrame: baseline, 3 months and end of intervention (6 months)
measure: Change in treatment satisfaction measured with the Client Satisfaction Questionnaire (CSQ)
timeFrame: baseline and 6 months
measure: App Rating Questionnaire (ARQ) and usage of the Momentum app will be combined to report patients self-perceived usefulness of the app
timeFrame: 6 months
measure: Change in treatment alliance measured with the Working Alliance Inventory - short version (WAI-S). Patient version.
timeFrame: baseline and 6 months
measure: Change in treatment alliance measured with the Working Alliance Inventory - short version (WAI-S). Clinician version.
timeFrame: baseline and 6 months
measure: Clinical Decision Making Style - Service user (CDMS-P)
timeFrame: baseline
measure: Clinical Decision Making Style - Staff questionnaire (CDMS-S).
timeFrame: baseline
measure: Service Engagement Scale - Collaboration sub-domain only (SES)
timeFrame: baseline and 6 months
measure: Change in positive symptoms measured by the Scale for the Assessment of Positive Symptoms (SAPS)
timeFrame: baseline and 6 months
measure: Change in negative symptoms measured by the Scale for the Assessment of Negative Symptoms (SANS)
timeFrame: baseline and 6 months
measure: Change in level of functioning measured with the Global Assessment of Functioning (GAF)
timeFrame: baseline and 6 months
measure: Change in level of functioning measured with the Personal and Social Performance Scale (PSP)
timeFrame: baseline and 6 months
Other outcomes:
measure: Objective data on app usage
timeFrame: 3 months and 6 months
measure: Anti-psychotic medicine
timeFrame: baseline and 6 months
measure: Adherence to treatment
timeFrame: baseline, 3 months and 6 months
measure: Hospital admissions
timeFrame: baseline, 3 months and 6 months
Locations:
city: Amager
country: Denmark
facility: OPUS Amager
city: Ballerup
country: Denmark
facility: OPUS Ballerup
city: Brøndby
country: Denmark
facility: OPUS Glostrup
city: Brøndby
country: Denmark
facility: OPUS Hvidovre
city: Brøndby
country: Denmark
facility: OPUS Valby
city: Hillerød
country: Denmark
facility: OPUS Hillerød
city: København Ø
country: Denmark
facility: OPUS Østerbro
Study officials:
affiliation: Mental Health Services in the Region of Southern Denmark, Odense
name: Lisa Korsbek, ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vitger T, Hjorthoj C, Austin SF, Petersen L, Tonder ES, Nordentoft M, Korsbek L. A Smartphone App to Promote Patient Activation and Support Shared Decision-making in People With a Diagnosis of Schizophrenia in Outpatient Treatment Settings (Momentum Trial): Randomized Controlled Assessor-Blinded Trial. J Med Internet Res. 2022 Oct 26;24(10):e40292. doi: 10.2196/40292.
citation: Vitger T, Austin SF, Petersen L, Tonder ES, Nordentoft M, Korsbek L. The Momentum trial: the efficacy of using a smartphone application to promote patient activation and support shared decision making in people with a diagnosis of schizophrenia in outpatient treatment settings: a randomized controlled single-blind trial. BMC Psychiatry. 2019 Jun 17;19(1):185. doi: 10.1186/s12888-019-2143-2.