- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01185249
Congestive Heart Failure Weight Study
June 19, 2013 updated by: Central DuPage Hospital
Time of Day and Accurate Weights for Patients With Congestive Heart Failure (CHF)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Winfield, Illinois, United States, 60190
- Central DuPage Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alice M Siehoff, DNP, RN-BC, Central DuPage Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
August 18, 2010
First Submitted That Met QC Criteria
August 18, 2010
First Posted (Estimate)
August 19, 2010
Study Record Updates
Last Update Posted (Estimate)
July 25, 2013
Last Update Submitted That Met QC Criteria
June 19, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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