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临床试验/NCT03762460
NCT03762460已完成不适用

Pilot Randomized Clinical Trial of eHealth Tools

University of British Columbia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period

研究概览

简要总结

This feasibility study investigates the use of eHealth tools within routine medical treatment for patients with depression in an outpatient psychiatric setting. The study investigates whether patients find a mobile-optimized online eHealth tool to be acceptable and feasible, and whether clinical and functional outcomes improve with use of the online eHealth tool, compared to informational online resources for mental health.

详细描述

Major Depressive Disorder (MDD) is increasingly recognized as the most common psychiatric disorder and as one of the most common medical diagnoses worldwide.

Measurement-based care (MBC) is an evidence-based approach for providing effective clinical care to patients with MDD. MBC utilizes validated rating scales to assess symptom severity, functional impairments, treatment adherence, and side-effect burden to personalize clinical decision-making based on measured outcomes and clinical algorithms. However, despite evidence demonstrating improved outcomes, MBC is still not routinely used by physicians. Barriers to the use of MBC include lack of knowledge of which scales to use, how to incorporate measurements into clinical charting systems, and the extra time needed for repeated assessments.

Our research team developed a web-based application (app) optimized for mobile devices to address the treatment gap in MBC for people with depression, especially those who are working while depressed. This user-friendly eHealth tool encourages patients to actively participate in MBC by using their smartphones, tablets, or computers to screen, monitor, and manage depressive symptoms and functional outcomes. Results can be easily displayed and printed to share with clinicians, thereby affording health professionals a simple and cost-effective means to integrate MBC into standard practices and to optimize treatment for MDD at the point of care, without needing additional materials, equipment, or staffing.

This research study investigates the feasibility of using a mobile-optimized online eHealth tool to support MBC in routine clinical care for MDD within an outpatient psychiatric setting.

To determine both the clinical and practical utility of eMBC, this study will enroll "real-world" patients with few exclusion criteria and undergoing naturalistic treatments so that findings will be generalizable to other clinical settings and practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age 19-65 and capable of informed consent;
  • •diagnosis of major depressive episode (MDE) by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria as determined by the clinic psychiatrist;
  • •at least moderate depression as defined by QIDS-SR score of 10 or higher on the Quick Inventory for Depressive Symptomatology, Self-Rated (QIDS-SR);
  • •access to an Internet-enabled computer or mobile device; and
  • •able to read and understand English sufficiently to use the eMBC platform

排除标准

  • •active psychotic or substance use disorder; or
  • •severe suicidality as judged by the psychiatrist.

研究组 & 干预措施

Online eHealth Tool

Experimental

Participants randomized to this group will use a personally-owned smartphone, tablet, or computer to access the online eHealth tool.

干预措施: Online eHealth tool (Other)

Informational website (control)

Placebo Comparator

Participants randomized to this group will receive information about online resources for mental health

干预措施: Informational website (Other)

结局指标

主要结局

Feasibility-of-use outcome: Percentage of patients who use the eHealth tool (MoodFx) 3 or more times over the 6-month period

时间窗: 6 months

Percentage of patients who use the eHealth tool (MoodFx), defined as 3 or more uses over the 6-month follow up period

次要结局

  • Change scores on the Sheehan Disability Scale (SDS) from baseline to follow up at 8 weeks and 6 months.(8 weeks and 6 months)
  • Satisfaction with eHealth tool as measured by the System Usability Scale.(6 months)
  • Change scores on the Quick Inventory of Depressive Symptomatology (QIDS-SR) from baseline to follow up at 8 weeks and 6 months.(8 weeks and 6 months)
  • Change scores on the Patient Health Questionnaire (PHQ-9) from baseline to follow up at 8 weeks and 6 months.(8 weeks and 6 months)
  • Change scores on the Generalized Anxiety Disorder scale (GAD-7) from baseline to follow up at 8 weeks and 6 months.(8 weeks and 6 months)
  • Change scores on the Lam Employment Absence and Productivity Scale (LEAPS) from baseline to follow up at 8 weeks and 6 months.(8 weeks and 6 months)
  • Change scores on the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) from baseline to follow up at 8 weeks and 6 months.(8 weeks and 6 months)
  • Change scores on the Euro-QOL-5Lscale (EQ-5D-5L) from baseline to follow up at 8 weeks and 6 months.(8 weeks and 6 months)

研究者

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

Raymond Lam

Professor

University of British Columbia

研究点 (1)

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