Congestive Heart Failure Weight Study

NCT01185249 | Completed Results DMC

• 1 other identifier: 10-010
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

CHF; congestive heart failure

Outcome Measures

Primary Outcomes (1)

• The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients

  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.

Study Arms (1)

Body weight taken in a standing position

EXPERIMENTAL

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

Interventions

Weigh subjects on a scale in the standing position PROCEDURE

Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.

Body weight taken in a standing position

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central DuPage Hospital: lead

Study Sites (1)

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Pilot study with small sample size in one patient population.

Results Point of Contact

• Title: Dr. Alice Siehoff, Nurse Scientist
• Organization: Central DuPage Hospital

asiehoffrn@msn.com

1-630-858-0260

Study Officials

• Alice M Siehoff, DNP, RN-BC

  Central DuPage Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: August 19, 2010
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2011
• Last Updated: July 25, 2013
• Results First Posted: July 25, 2013

Record last verified: 2013-06

Locations

US (1)