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Congestive Heart Failure Weight Study

This study has been completed.
Sponsor:
Information provided by:
Central DuPage Hospital
ClinicalTrials.gov Identifier:
NCT01185249
First received: August 18, 2010
Last updated: July 7, 2011
Last verified: July 2011
History of Changes
  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: 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:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Central DuPage Hospital:

Primary Outcome Measures:
  • To measure the difference between early morning and evening weights for CHF patients [ Time Frame: 5am weight and 8pm weight to be taken ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: August 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alice Siehoff, Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01185249     History of Changes
Other Study ID Numbers: 10-010
Study First Received: August 18, 2010
Last Updated: July 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Central DuPage Hospital:
CHF
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013