Orthostatic Hypotension in Rehabilitation Patients

NCT ID: NCT00117585

Last Updated: 2016-04-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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 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

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Hypotension, Orthostatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type OTHER

Treatment Phase 1

Intervention Type OTHER

* Patient Education
* Physical Therapy Exercises
* Increased Salt Intake
* Elevation of head of bed with 2-4 inch wedge
* Medication Review by MD, Pharma

Treatment Phase 2

Intervention Type DRUG

Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.

* Fludrocortisone
* Salt tablet

Treatment Phase 3

Intervention Type OTHER

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.

Interventions

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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

Intervention Type OTHER

Treatment Phase 2

Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.

* Fludrocortisone
* Salt tablet

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Florinef

Eligibility Criteria

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Inclusion Criteria

* Admitted to Vancouver VA Nursing Home or Rehabilitation ward

Exclusion Criteria

* Unable to stand upon admission
* Hospice admission
* Respite admission
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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E3616-R

Identifier Type: -

Identifier Source: org_study_id

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