NCT01362751

Brief Summary

In this study the investigators aimed

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

1.4 years

First QC Date

October 7, 2010

Last Update Submit

September 2, 2012

Conditions

Outcome Measures

Primary Outcomes (2)

  • Orthostatic hypotension

    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

    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 Outcomes (3)

  • All-cause and Cardiovascular mortality

    Date of death

  • Quality of life

    Measured at baseline and after 1 year

  • Fall incidents

    After 5 years

Study Arms (1)

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

Interventions

This study is an observational cohort study \> no interventions

Nursing home residents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Nursing home residents

You may qualify if:

  • nursing home resident

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing home TriviumMeulenbeltZorg, location Borsthuis

Hengelo, Netherlands

Location

Related Publications (1)

  • Hartog LC, Cizmar-Sweelssen M, Knipscheer A, Groenier KH, Kleefstra N, Bilo HJ, van Hateren KJ. The association between orthostatic hypotension, falling and successful rehabilitation in a nursing home population. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):190-6. doi: 10.1016/j.archger.2015.05.005. Epub 2015 May 18.

MeSH Terms

Conditions

Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2010

First Posted

May 30, 2011

Study Start

October 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations