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Congestive Heart Failure Weight Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central DuPage Hospital
ClinicalTrials.gov Identifier:
NCT01185249
First received: August 18, 2010
Last updated: June 19, 2013
Last verified: June 2013
  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:


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. ] [ Designated as safety issue: No ]

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

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
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: 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: Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01185249     History of Changes
Other Study ID Numbers: 10-010
Study First Received: August 18, 2010
Results First Received: December 3, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Central DuPage Hospital:
CHF
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014