跳至主要内容
临床试验/NCT02025647
NCT02025647已完成不适用

An Open, Non-Randomized, Evaluation of Innerview™, an MHCDS Tool Used to Report Symptoms and Functioning Related to Common Mental Health Disorders in the Primary Care Setting

Pearson/Clinical Assessment5 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
139
试验地点
5
主要终点
Standard Error of Measure for the Individualized Rating Scale (Rating Module)

研究概览

简要总结

Innerview can address some of the challenges of integrating mental health and primary care by accurately and reliably collecting mental health evidence and activities directly from patients, and then organizing and automating that evidence and activity into reports for providers and care teams that support diagnosis, treatment planning and monitoring of the mental health issues within a practice population.

详细描述

To deliver integrated quality care, innovative strategies are needed to efficiently collect, understand, monitor and manage mental health evidence and its contribution to the primary care office visit. Computer applications can provide solutions to providers by helping their processes to be feasible, manageable, and sustainable. We hypothesize that by both providing patients the opportunity to reflect on their physical, emotional and behavioral symptoms and functioning, and giving providers accurate, reliable, current, symptom-based mental health evidence in an accessible organized format prior to the face-to-face visit, Innerview will enhance diagnostic and treatment processes from both a patient- and population-based perspective, as well as enhance communication between patient and provider.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • Provide signed and dated informed consent form
  • Be aged 18 or older
  • Be willing to comply with all study procedures and be available for the duration of the study
  • Be able to read English at an 8th grade level (as determined by physician)
  • Have internet access to email with a computer and/or tablet

排除标准

  • Patients are excluded from study participation if they meet any of the following criteria:
  • Inability to provide consent due to guardianship issues
  • Currently experiencing psychotic symptoms (as determined by physician)
  • Anything that, in the opinion of the Investigator, would preclude the subject's full compliance with or completion of the study.

结局指标

主要结局

Standard Error of Measure for the Individualized Rating Scale (Rating Module)

时间窗: approximate 5 minutes between ratings

What is the standard error of measurement (SEM) for test/retest symptom ratings on a 0 - 10 point scale

Accuracy of the Narrative Module

时间窗: Immediate

Out of 139 subjects using Innerview for the first time, how many subjects approved their initial version of their narrative versus chose to start over?

Reliability of the Narrative Module

时间窗: 24-48 hours

What is the consistency of the diagnostic criteria generated by two administrations, 1 to 2 days apart?

次要结局

  • Provider Survey (Question 8)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 4)(Immediate)
  • Provider Survey (Question 1)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 5)(Immediate)
  • Subject Survey (Question 6)(Immediate)
  • Subject Survey (Question 7)(Immediate)
  • Provider Survey (Question 2)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 4)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 10)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 3)(Immediate)
  • Provider Survey (Question 3)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 6)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 7)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 8)(Immediate)
  • Subject Survey (Question 9)(Immediate)
  • Subject Survey (Question 10)(Immediate)
  • Provider Survey (Question 5)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 9)(Administered Innerview session on at least 15 subjects)
  • Provider Survey (Question 11)(Administered Innerview session on at least 15 subjects)
  • Subject Survey (Question 1)(Immediate)
  • Subject Survey (Question 2)(Immediate)

研究者

发起方
Pearson/Clinical Assessment
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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