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临床试验/NCT00296140
NCT00296140已完成不适用

Implementation Evidence in the Detection and Treatment of Post-stroke Depression

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2006年12月13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
66
试验地点
2
主要终点
PHQ-9

研究概览

简要总结

Post Stroke Depression (PSD)is a high volume condition with negative impact on patient recovery after stroke. The primary aim of this study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and started on treatment for PSD.

The secondary aim is evaluate whether a patient-based self-management intervention provides any additional benefit compared to usual care.

详细描述

Objective:

The investigators' immediate objective is to test a system intervention to evaluate which aspects of the intervention are critical to improving the quality of care for veterans with PSD, and to refine it to prepare for the investigators' long-term objective: a multi-site study across multiple facilities and Veteran Integrated Service Networks (VISNs). To address the immediate objective, the investigators will evaluate two specific study aims using a quasi-experimental design comparing improvement in depression screening and treatment in veteran stroke survivors receiving care at two facilities receiving the intervention.

The primary aim of the study is to evaluate the effectiveness of a system intervention to improve the proportion of Veterans screened and treated for PSD. The system intervention is based on extending the use of the current depression performance measure that mandates yearly depression screening in VA primary care clinics to target veteran stroke survivors following-up in Veterans Administration (VA) Primary Care or Neurology clinics within six months of stroke. The primary outcome is the effect of the intervention on depression screening and treatment rates. The secondary aim of the study is to evaluate whether a patient-based self-management intervention provides additional benefit beyond the system intervention alone in improving patient depression symptoms, quality of life, and self-efficacy compared to usual post-stroke care. Subjects for the secondary aim will be recruited from the two intervention sites and will be randomized, stratified by site, to the patient intervention or usual care.

Hypotheses/Key Research Questions:

Specific Aim 1: To determine whether the system implementation intervention improves a) detection, and b) guideline-adherent treatment of PSD. Aim 1 Hypotheses: Compared to the base rate of PSD screening and treatment at the two intervention facilities, the system intervention will result in at least a 25% increase in: a) The proportion of Veterans screened for PSD in the first six months after stroke, and b) The proportion of Veterans with PSD that receive guideline-adherent depression treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Aim 1 - veterans with ischemic stroke hospitalized at any of the VISN 8 or 11 facilities during the 18th month enrollment period.
  • •Aim 2 - veterans hospitalized at the Indianapolis or Gainesville VAMC's.

排除标准

  • •Aim 1 - none
  • •Aim 2 - 18 or younger, unable to speak or understand English, severe cognitive impairments, no access to telephone, not willing to follow-up at VA for outpatient care, unwilling to participate in interviews and/or life expectancy less than 6 months.

研究组 & 干预措施

self management of PSD symptoms

Other

干预措施: self management of PSD symptoms (Behavioral)

screening and treatment of PSD

Other

干预措施: screening and treatment of PSD (Procedure)

结局指标

主要结局

PHQ-9

时间窗: 6 months

Patient Health Questionnaire-9, measures depression symptoms, range 0-27, higher values represent more depression symptoms

次要结局

  • SS-QOL(6 months)
  • Self-efficacy(6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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