Orthostatic Hypotension in Elderly Nursing Home Residents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kornelis J.J. van Hateren, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT01362751
First received: October 7, 2010
Last updated: September 2, 2012
Last verified: September 2012
  Purpose

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.

Condition Intervention
Orthostatic Hypotension
Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • Orthostatic hypotension [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • Successful rehabilitation [ Time Frame: After 5 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • All-cause and Cardiovascular mortality [ Time Frame: Date of death ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at baseline and after 1 year ] [ Designated as safety issue: No ]
    Quality of life is measured using the RAND-36 questionnaire.

  • Fall incidents [ Time Frame: After 5 years ] [ Designated as safety issue: No ]

Enrollment: 290
Study Start Date: October 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Nursing home residents

Criteria

Inclusion Criteria:

  • nursing home resident

Exclusion Criteria:

  • patients at the palliative department
  • life expectancy < 4 weeks
  • patients only temporarily admitted to the nursing home
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362751

Locations
Netherlands
Nursing home TriviumMeulenbeltZorg, location Borsthuis
Hengelo, Netherlands
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
  More Information

No publications provided

Responsible Party: Kornelis J.J. van Hateren, MD, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01362751     History of Changes
Other Study ID Numbers: OH_TMZ_2010
Study First Received: October 7, 2010
Last Updated: September 2, 2012
Health Authority: Medical ethics committee, Isala Clinics, Zwolle, The Netherlands ':'

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Autonomic Nervous System Diseases
Cardiovascular Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014