The Efficacy of Using a Smartphone App to Support Shared Decision Making in People With a Diagnosis of Schizophrenia

NCT03554655 | Completed

• 2 other identifiers: 115441H-17025550
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 7

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.

Conditions

Schizophrenia, Schizotypal and Delusional Disorders

Keywords

Shared decision making; Patient activation; Schizophrenia; First-episode psychosis; mHealth; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in patient activation measured with the Consumer Health Activation Index - Mental Health (CHAI-MH)

  Completed by patients. The 10-item instrument was developed based on 5 key domains: knowledge, self-efficacy, motivation and beliefs, actions, and internal locus of control. The questionnaire is rated on a 6-point Likert scale ranging from "Strongly disagree" to "Strongly agree". Afterwards, the scores are transformed into a theoretical value from 0 to 100, with higher scores signifying a stronger involvement in the treatment and confidence in the ability to take care of one's own health and health treatment.

  baseline, 3 months and end of intervention (6 months)

Secondary Outcomes (15)

• Change in self-efficacy measured with the General Self-Efficacy scale (GSE)

  baseline, 3 months and end of intervention (6 months)

• Change in preparedness for decision making measured with the scale Preparation for Decision Making (PrepDM)

  baseline and 6 months

• Change in hope measured with the Adult State Hope Scale (ASH)

  baseline, 3 months and end of intervention (6 months)

• Change in the efficacy of interactions measured with the scale Perceived Efficacy in Patient-Provider Interactions (PEPPI)

  baseline, 3 months and end of intervention (6 months)

• Change in treatment satisfaction measured with the Client Satisfaction Questionnaire (CSQ)

  baseline and 6 months

Other Outcomes (4)

• Objective data on app usage

  3 months and 6 months

• Anti-psychotic medicine

  baseline and 6 months

• Adherence to treatment

  baseline, 3 months and 6 months

Study Arms (2)

Intervention: Momentum app

EXPERIMENTAL

Intervention Group will receive treatment as usual together with the Momentum app.

Device: Momentum app

Control

NO INTERVENTION

Control Group will receive treatment as usual without the Momentum app.

Interventions

Momentum app DEVICE

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.

Intervention: Momentum app

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• TrygFonden, Denmark: collaborator
• Odense Patient Data Explorative Network: collaborator

Study Sites (7)

OPUS Amager

Amager, 2300, Denmark

Location

OPUS Ballerup

Ballerup Municipality, 2750, Denmark

Location

OPUS Glostrup

Brøndby, 2605, Denmark

Location

OPUS Hvidovre

Brøndby, 2605, Denmark

Location

OPUS Valby

Brøndby, 2605, Denmark

Location

OPUS Hillerød

Hillerød, 3400, Denmark

Location

OPUS Østerbro

København Ø, 2100, Denmark

Location

Related Publications (2)

• 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.

  PMID: 36287604 DERIVED

• 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.

  PMID: 31208376 DERIVED

Related Links

• OPEN

MeSH Terms

Conditions

Schizophrenia; Schizophrenia, Paranoid; Patient Participation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Lisa Korsbek, ph.d.

  Mental Health Services in the Region of Southern Denmark, Odense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention, patients and healthcare providers cannot be kept blinded. Investigators responsible for data collection and data entry will be blinded as to patient allocation until all outcomes have been collected.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: June 13, 2018
• Study Start: January 7, 2019
• Primary Completion: September 30, 2021
• Study Completion: January 30, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (7)