Orthostatic Hypotension in Elderly Nursing Home Residents

September 2, 2012 updated by: Kornelis J.J. van Hateren, Medical Research Foundation, The Netherlands

In this study the investigators aimed

  1. to investigate the prevalence of orthostatic hypotension in elderly nursing home residents.
  2. to investigate whether the presence of orthostatic hypotension influences the chance of successful rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Hengelo, Netherlands
        • Nursing home TriviumMeulenbeltZorg, location Borsthuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nursing home residents

Description

Inclusion Criteria:

  • nursing home resident

Exclusion Criteria:

  • patients at the palliative department
  • life expectancy < 4 weeks
  • patients only temporarily admitted to the nursing home

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nursing home residents
In this study, patients from both the somatic and the psychogeriatric department are included. For the primary endpoint 'successful rehabilitation' only the patients from the somatic departments are included.
Other: No intervention
This study is an observational cohort study > no interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orthostatic hypotension
Time Frame: Baseline
Orthostatic hypotension is defined by consensus as a fall in blood pressure of at least 20 mmHg systolic or 10 mmHg diastolic within 3 minutes in the upright position
Baseline
Successful rehabilitation
Time Frame: After 5 years
Successful rehabilitation is defined as whether the patient is able to return to his/her home or another location (but not a nursing home) after discharge from the nursing home. Unsuccessful rehabilitations implies that the patients becomes a long-stay nursing home resident.
After 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause and Cardiovascular mortality
Time Frame: Date of death
Date of death
Quality of life
Time Frame: Measured at baseline and after 1 year
Quality of life is measured using the RAND-36 questionnaire.
Measured at baseline and after 1 year
Fall incidents
Time Frame: After 5 years
After 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Foundation, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

May 30, 2011

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 2, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OH_TMZ_2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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