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临床试验/NCT02765542
NCT02765542已完成不适用

Developing Accessible mHealth Programs for Depression Management in Bolivia

University of Michigan1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)

研究概览

简要总结

The purpose of the study is to evaluate the feasibility and potential impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with depression in Bolivia.

详细描述

All patients will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 12 weeks. During enrollment, the research team will explain how to use the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, symptoms of depression, and medication adherence (if patients are prescribed an anti-depressant). Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, if possible, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate who will be present.

In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.

The intervention will last up to 12 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone.

研究设计

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

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21-80 years of age
  • PHQ-8 score of 10 or higher

排除标准

  • Have diagnoses indicating a six-month life expectancy
  • Prior inpatient psychiatric treatment
  • Patients with probable bipolar disorder or cognitive impairment as indicated on validated screeners

结局指标

主要结局

Change from baseline on depressive symptoms at 12 weeks (PHQ-8 Scores)

时间窗: Baseline and 12 week post-intervention follow-up

次要结局

  • Evaluate program feasibility (telephone call completion rates)(12 week post-intervention follow-up)
  • Change from baseline on self-care behaviors at 12 weeks (self-care behavior questionnaire)(Baseline and 12 week post-intervention follow-up)
  • Patient satisfaction (satisfaction questionnaire)(12 week Post-intervention follow-up)
  • Patient qualitative feedback (qualitative questionnaire)(12 week Post-intervention follow-up)

研究者

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

John Piette

VA Senior Research Career Scientist, Professor of Health Behavior and Health Education and of Internal Medicine

University of Michigan

研究点 (1)

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