Congestive Heart Failure Weight Study

• ClinicalTrials.gov Identifier: NCT01185249
• Recruitment Status: Completed
• First Posted: August 19, 2010
• Results First Posted: July 25, 2013
• Last Update Posted: July 25, 2013
• Sponsor: Central DuPage Hospital
• Information provided by (Responsible Party): Central DuPage Hospital

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Congestive Heart Failure	Procedure: Weigh subjects on a scale in the standing position	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: N/A
• 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)
• Study Start Date: August 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 10-010
• First Posted: August 19, 2010
• 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