Back to resultsCongestive Heart Failure Weight Study
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weigh subjects on a scale in the standing position
Sponsored by
About this trial
This is an interventional supportive care trial for Congestive Heart Failure focused on measuring CHF, congestive heart failure
Eligibility 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
Sites / Locations
- Central DuPage Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Body weight taken in a standing position
Arm Description
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.
Outcomes
Primary Outcome Measures
The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01185249
Brief Title
Congestive Heart Failure Weight Study
Official Title
Time of Day and Accurate Weights for Patients With Congestive Heart Failure (CHF)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central DuPage Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
CHF, congestive heart failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body weight taken in a standing position
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Weigh subjects on a scale in the standing position
Intervention Description
Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.
Primary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice M Siehoff, DNP, RN-BC
Organizational Affiliation
Central DuPage Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
12. IPD Sharing Statement
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Congestive Heart Failure Weight Study
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