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Congestive Heart Failure Weight Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185249
First Posted: August 19, 2010
Last Update Posted: July 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Central DuPage Hospital
  Purpose
Early morning weights to monitor CHF patient's fluid status is common practice but there is a lack of evidence that this is the best practice. The purpose of this study is to determine if there is a difference in net weight gain or loss for hospitalized patients with CHF who are weighed in the evening instead of early morning.

Condition Intervention
Congestive Heart Failure Procedure: Weigh subjects on a scale in the standing position

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Time of Day and Accurate Weights for Patients With Congestive Heart Failure (CHF)

Resource links provided by NLM:


Further study details as provided by Central DuPage Hospital:

Primary Outcome Measures:
  • The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients [ Time Frame: Mean differences in the morning (5am) weights compared for three consecutive days. Day 1, Day 2, Day 3. Mean difference in the morning (5am) and evening (8pm) weights for three consecutive days. Day 1, Day 2, Day 3. ]

Enrollment: 66
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Body weight taken in a standing position
Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
Procedure: Weigh subjects on a scale in the standing position
Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.

Detailed Description:
This is a quasi-experimental pilot study with prospective cohort design. Study subjects will be weighed in the early morning and then again in the evening for a minimum of three days. Analysis will be accomplished on data by analysis within-subjects data utilizing the paired t test. Other data to be collected includes dates of hospitalization, demographics, dose and timing of medications, lab results and documentation of comorbid conditions.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-85 years old
  • Admitted to hospital with a primary diagnosis of heart failure or fluid overload
  • Ambulatory with a medical order to be out of bed
  • Able to stand on a scale
  • Have no problems with balance

Exclusion Criteria:

  • Patients with a primary diagnosis other than heart failure or fluid overload
  • Patients diagnosed with renal failure
  • Non-English speaking
  • Unable to follow directions or consent due to cognitive impairment
  • Medical order for bed rest
  • Involved in another study
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01185249


Locations
United States, Illinois
Central DuPage Hospital
Winfield, Illinois, United States, 60190
Sponsors and Collaborators
Central DuPage Hospital
Investigators
Principal Investigator: Alice M Siehoff, DNP, RN-BC Central DuPage Hospital
  More Information

Responsible Party: Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01185249     History of Changes
Other Study ID Numbers: 10-010
First Submitted: August 18, 2010
First Posted: August 19, 2010
Results First Submitted: December 3, 2012
Results First Posted: July 25, 2013
Last Update Posted: July 25, 2013
Last Verified: June 2013

Keywords provided by Central DuPage Hospital:
CHF
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases


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