跳至主要内容
临床试验/NCT00117585
NCT00117585已完成不适用

Orthostatic Hypotension in Rehabilitation Patients

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 341 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
341
试验地点
1
主要终点
Orthostatic Hypotension at Discharge

研究概览

简要总结

The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.

详细描述

This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the intervention. Patients will be enrolled over two research phases and the investigators expect to evaluate 459 subjects. This research program will occur over a three-year period.

Methods:

During Phase I, baseline prevalence and natural history of OH will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring OH 3 times weekly over their inpatient stay. In addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. During Phase II, the investigators will implement a standardized, interdisciplinary (MD/RN/PT/Dietician) treatment plan for patients with OH. This will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. The goals of the interventions are to identify and treat the underlying causes of OH in rehabilitation patients. Based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Admitted to Vancouver VA Nursing Home or Rehabilitation ward

排除标准

  • Unable to stand upon admission
  • Hospice admission
  • Respite admission

研究组 & 干预措施

Treatment Phase 1

Other

Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)

干预措施: Treatment Phase 1 (Other)

Treatment Phase 1

Other

Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)

干预措施: Treatment Phase 2 (Drug)

Treatment Phase 1

Other

Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3)

干预措施: Treatment Phase 3 (Other)

结局指标

主要结局

Orthostatic Hypotension at Discharge

时间窗: Last three blood pressures prior to discharge

Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验