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临床试验/NCT03649815
NCT03649815已完成早期 1 期

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

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年4月18日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
38
试验地点
1
主要终点
Treatment Adherence

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Use of mHealth Technology

Experimental

This single arm of the study involves the provision of the mobile health technology entitled App4Independence.

干预措施: App4Independence (Combination Product)

结局指标

主要结局

Treatment Adherence

时间窗: 1 month

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.

Symptomatology

时间窗: 1 Month

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.

Recovery Process Engagement

时间窗: 1 month

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Kidd

Senior Scientist

Centre for Addiction and Mental Health

研究点 (1)

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