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Orthostatic Hypotension in Rehabilitation Patients

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ClinicalTrials.gov Identifier: NCT00117585
Recruitment Status : Completed
First Posted : July 7, 2005
Results First Posted : July 4, 2014
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypotension, Orthostatic Other: Treatment Phase 1 Drug: Treatment Phase 2 Other: Treatment Phase 3 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Orthostatic Hypotension in Rehabilitation Patients
Study Start Date : November 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Treatment Phase 1
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)
 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 Name: Florinef

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.


Outcome Measures
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Primary Outcome Measures :
  1. Orthostatic Hypotension at Discharge [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to Vancouver VA Nursing Home or Rehabilitation ward

Exclusion Criteria:

  • Unable to stand upon admission
  • Hospice admission
  • Respite admission
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117585


Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00117585    
Other Study ID Numbers: E3616-R
First Posted: July 7, 2005    Key Record Dates
Results First Posted: July 4, 2014
Last Update Posted: April 18, 2016
Last Verified: March 2016
Keywords provided by VA Office of Research and Development:
Aging
Blood pressure
Hypotension
Orthostatic
Rehabilitation
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
 Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases