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Schizophrenia Spectrum and Other Psychotic DisordersEarly Phase 1NCT03649815

Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum

A Early Phase 1 study testing App4Independence in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This protocol describes an attempt to capture the development phase of a mobile support for individuals with schizophrenia. The intent is to describe and account for a rigorous development process that will result in the creation of a beta version that would be tested in a randomized trial for effectiveness - to be… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
App4Independence
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteCanada
Study dates
18 Apr 2017to 8 May 2018
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Are 18 years of age or older
  • Have a schizophrenia spectrum diagnosis
  • Own and regularly use a smart phone equipped with an Android operating system and a talk and data plan
  • Read and speak conversational English

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Official title: Testing the Feasibility and Outcomes of a Digital Health Support for Individuals With Schizophrenia Spectrum Mental Illnesses

This protocol describes an attempt to capture the development phase of a mobile support for individuals with schizophrenia. The intent is to describe and account for a rigorous development process that will result in the creation of a beta version that would be tested in a randomized trial for effectiveness - to be addressed in a subsequent protocol

Read the detailed description

General Issues The most common contributors to relapse in schizophrenia and associated mental illnesses are medication non-adherence, social isolation, and inadequate supports. Driven to a large extent by system of care shortcomings and the many challenges presented by symptoms, the impacts of these problems are profound from individual to system levels. This is a global issue, and to date technology has not been substantively leveraged in generating solutions - despite evidence of substantial uptake of relevant technologies by relevant populations. To date, there are few products on the market that address the constellation of issues outlined above. It is an area where a nuanced approach is needed as this illness is highly diverse in presentation, attended by a number of social determinants of health that greatly affect outcomes and, quite commonly, ambivalence with respect to service provider and caregiver engagement. This scenario as it exists for schizophrenia stands in sharp contrast with the many thousands of applications developed for other mental health issues.

Cellphone Based Technologies and Schizophrenia There is a small, emergent literature that is examining the feasibility and outcomes of mobile applications that address schizophrenia. Broadly, targeted mobile and online applications in areas such as cognitive remediation (brain training games) have been found feasible and do not result in any noted risks in their use and there have been promising findings in outcome studies of emergent mHealth strategies for schizophrenia of the kind tested here.

Local Work in this Area to Date

Initial mapping of key domains relevant to an app in this area has been conducted based upon the experience of the collaborators and an understanding of the relevant practice literatures. This initial draft, which might be considered a 'paper prototype', let to the identification of the following needs:

The platform would:

  • Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
  • Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw upon evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
  • Facilitate automated support and link to caregivers
  • Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
  • Provide basic health/safety functionality and track level of wellness

Specifically, the app was designed to be made up of 4 functional areas:

  1. A needs assessment in order to determine care/interaction pathway, crisis planning and routine builders, accompanied by ongoing assessment to keep components relevant and engaging and to facilitate treatment planning and support by providers.
  2. Daily interactions and check-in functionality for self-determination of messaging, reward messaging, social interaction content.
  3. An algorithm to determine content based on ambient and interaction data content triggers and risk flagging built on evidence-based guidelines.
  4. Self-Management portal and caregiver dashboard.

Research Objective

This study was undertaken to engage in a rigorous process of feasibility testing. This will then be followed by a randomized trial of the beta version that will be generated through the process outlined in this protocol (will be the subject of a subsequent protocol and not addressed here). As such, the objective of this research is to capture and record the process of development of a functional, beta version of this technology. This test includes outcome data derived from 1 month of app use comprised of both qualitative feedback and quantitative outcome data. The objective is to determine feasibility prior to further trials and validation efforts.

Being tested
App4Independence
Keywords
schizophrenia, psychosis, mHealth, digital health
Medical subject headings
Schizophrenia Spectrum and Other Psychotic Disorders, Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • App4IndependenceCombination product

    The mobile, app-based platform was designed to:

    • Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
    • Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
    • Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
    • Provide basic health/safety functionality and track level of wellness
    • Provide an anonymous peer-peer online network for strategy sharing
    • Provide an ambient sound detector to assist with identifying hallucinations
Study groups in NCT03649815
Study groupRoleWhat they receive
Use of mHealth TechnologyExperimentalThis single arm of the study involves the provision of the mobile health technology entitled App4Independence.
Receives: Combination Product: App4Independence

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptomatology

    The Brief Symptom Inventory (BSI) assesses the level of psychiatric symptomatology providing both total and subscale scores. All 53 items are 5-point likert with higher scores meaning higher symptomatology. For the overall score the total is used and can range from 0-212. Total scores from each of the 9 subscales are similarly used with higher scores meaning greater subscale symptomatology. Lowest scores for all are 0, with 20 the highest score for hostility, phobic anxiety, paranoid ideation, psychoticism; 16 the highest score for interpersonal sensitivity; 24 the highest for obsessive compulsive, depression, anxiety; and 28 for somatization.

    Measured: 1 Month

  2. Recovery Process Engagement

    Personal Recovery Outcome Measure (PROM) was used to assess degree of engagement in the recovery process. The prom has 30 items, all 5 point likert with higher scores meaning more recovery engagement. The metric is the total score (0-120)/4 to provide an adjusted score. There are no subscales.

    Measured: 1 month

  3. Treatment Adherence

    Brief Adherence Rating Scale (BARS) was used to examine implications of A4i for medication use. A total score ranging from 0-100 is provided with 100 indicating better adherence.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start18 Apr 2017
  3. Primary completion8 May 2018
  4. Study completion8 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649815
Sponsor's protocol ID
84-2016
Status last verified
May 2020
First submitted
23 Aug 2018
Last updated
4 Jun 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available via a supplementary file in the publication.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing App4Independence in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptomatology (time frame: 1 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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