Orthostatic Hypotension in Elderly Nursing Home Residents

Orthostatic Hypotension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362751
• Other study ID #: OH_TMZ_2010
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: September 2, 2012
• Start date: October 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Medical ethics committee, Isala Clinics, Zwolle, The Netherlands ':'
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Other:
• No intervention
This study is an observational cohort study > no interventions

Locations

Country	Name	City	State
Netherlands	Nursing home TriviumMeulenbeltZorg, location Borsthuis	Hengelo

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	All-cause and Cardiovascular mortality		Date of death	No
Secondary	Quality of life	Quality of life is measured using the RAND-36 questionnaire.	Measured at baseline and after 1 year	No
Secondary	Fall incidents		After 5 years	No