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
|Condition or disease||Intervention/treatment||Phase|
|Hypotension, Orthostatic||Other: Treatment Phase 1 Drug: Treatment Phase 2 Other: Treatment Phase 3||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||341 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Orthostatic Hypotension in Rehabilitation Patients|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||September 2008|
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
Drug: Treatment Phase 2
Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1.
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.
- 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.
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
|United States, Oregon|
|VA Portland Health Care System, Portland, OR|
|Portland, Oregon, United States, 97239|