Orthostatic Hypotension in Rehabilitation Patients
Primary Purpose
Hypotension, Orthostatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment Phase 1
Treatment Phase 2
Treatment Phase 3
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension, Orthostatic focused on measuring Aging, Blood pressure, Hypotension, Orthostatic, Rehabilitation
Eligibility Criteria
Inclusion Criteria: Admitted to Vancouver VA Nursing Home or Rehabilitation ward Exclusion Criteria: Unable to stand upon admission Hospice admission Respite admission
Sites / Locations
- VA Portland Health Care System, Portland, OR
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment Phase 1
Arm Description
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)
Outcomes
Primary Outcome Measures
Orthostatic Hypotension at 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00117585
First Posted
June 30, 2005
Last Updated
March 18, 2016
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00117585
Brief Title
Orthostatic Hypotension in Rehabilitation Patients
Official Title
Orthostatic Hypotension in Rehabilitation Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension, Orthostatic
Keywords
Aging, Blood pressure, Hypotension, Orthostatic, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
341 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Phase 1
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Treatment Phase 1
Intervention Description
Patient Education
Physical Therapy Exercises
Increased Salt Intake
Elevation of head of bed with 2-4 inch wedge
Medication Review by MD, Pharma
Intervention Type
Drug
Intervention Name(s)
Treatment Phase 2
Other Intervention Name(s)
Florinef
Intervention Description
Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.
Fludrocortisone
Salt tablet
Intervention Type
Other
Intervention Name(s)
Treatment Phase 3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Orthostatic Hypotension at Discharge
Description
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.
Time Frame
Last three blood pressures prior to discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted to Vancouver VA Nursing Home or Rehabilitation ward
Exclusion Criteria:
Unable to stand upon admission
Hospice admission
Respite admission
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Orthostatic Hypotension in Rehabilitation Patients
We'll reach out to this number within 24 hrs