NCT00117585

Orthostatic Hypotension in Rehabilitation Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypotension, Orthostatic

Interventions

Type	Name	Description
OTHER	Treatment Phase 1	* Patient Education * Physical Therapy Exercises * Increased Salt Intake * Elevation of head of bed with 2-4 inch wedge * Medication Review by MD, Pharma
DRUG	Treatment Phase 2	Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1. * Fludrocortisone * Salt tablet
OTHER	Treatment Phase 3	Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2005-07-07
• Last updated: 2016-04-18
• Results posted: 2014-07-04

Locations

1 site across 1 country: United States