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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00117585 |
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 |
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Hypotension |
Other: Treatment 1 Drug: Treatment 2 Other: Treatment 3 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Orthostatic Hypotension in Rehabilitation Patients |
Estimated Enrollment: | 459 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Stepped intervention consisting of three treatment phases
|
Other: Treatment 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 2
Fludrocortisone Salt tablets
Other: Treatment 3
Individualized treatment based on expert OH consult
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Admitted to Vancouver VA Nursing Home or Rehabilitation ward
Exclusion Criteria:
Contact: Kathleen Adams, MPH | (503) 220-8262 ext 33705 | kathleen.adams@va.gov |
Contact: Scott L Mader | (360) 690-1827 | scott.mader@va.gov |
United States, Oregon | |
VA Medical Center, Portland | Recruiting |
Portland, Oregon, United States, 97201 | |
Contact: Kathleen Adams, MPH 503-220-8262 ext 33705 kathleen.adams@va.gov | |
Contact: Scott L Mader (360) 690-1827 scott.mader@va.gov | |
Principal Investigator: Scott L Mader |
Principal Investigator: | Scott L Mader | VA Medical Center, Portland |
Responsible Party: | Department of Veterans Affairs ( Mader, Scott - Principal Investigator ) |
Study ID Numbers: | E3616R, 01328, 05-1304 |
Study First Received: | June 30, 2005 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00117585 |
Health Authority: | United States: Federal Government |
Aging Blood pressure Hypotension Orthostatic Rehabilitation |
Hypotension Postural hypotension Hypotension, Orthostatic Vascular Diseases Fludrocortisone |
Cardiovascular Diseases |