Orthostatic Hypotension in Rehabilitation Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00117585
First received: June 30, 2005
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

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 Intervention
Hypotension, Orthostatic
Other: Treatment Phase 1
Drug: Treatment Phase 2
Other: Treatment Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Orthostatic Hypotension in Rehabilitation Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Orthostatic Hypotension at Discharge [ Time Frame: Last three blood pressures prior to discharge ] [ Designated as safety issue: No ]
    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.


Enrollment: 341
Study Start Date: November 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1
Stepped intervention consisting of treatment phase 1, 2 and 3. Some subjects receive only treatment phase 1. Some subjects receive treatment phase 1 and, if orthostatic hypotension is still occurring, then treatment phase 2. Subjects still experiencing orthostatic hypotension after treatment phases 1 and 2 will progress to treatment phase 3. Patients are followed for the duration of hospital stay, an average of 4 weeks.
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, Pharmacist
Drug: Treatment Phase 2
  • Fludrocortisone
  • Salt tablets
Other Name: Florinef
Other: Treatment Phase 3
Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center

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 we 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, we 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117585

Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Investigators
Principal Investigator: David H. Hickam, MD MPH Portland VA Medical Center, Portland, OR
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00117585     History of Changes
Other Study ID Numbers: E3616-R
Study First Received: June 30, 2005
Results First Received: November 5, 2013
Last Updated: September 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Aging
Blood pressure
Hypotension
Orthostatic
Rehabilitation

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 22, 2014