Congestive Heart Failure
Conditions
Keywords
CHF, congestive heart failure
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.
Interventions
PROCEDUREWeigh 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.
Sponsors
Central DuPage Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Once all admission procedures were completed in the cardiac intermediate unit, the nursing staff asked CHF patients in their care, if they had interest in hearing more about the study. After a verbal yes, the PI or key personnel met with the patient to explain the study, review the consent form, and after ample time, obtain written consent.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patients discharged or change in status | 42 |
Baseline characteristics
| Characteristic | Body Weight Taken in a Standing Position |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age Continuous | 61 years STANDARD_DEVIATION 2.06 |
| Body Weight | 85.9 kilograms STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 |
Outcome results
Primary
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.
Population: Patients with three consecutive days of morning and evening weights.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evening Weights | The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients | 2.47 kilograms | Standard Deviation 1.8 |
| Morning Weight | The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients | 3.09 kilograms | Standard Deviation 2.06 |
Comparison: Analysis of within subjects design morning and evening weights. Null hypothesis is that there is no difference between morning and evening weights.p-value: <0.00195% CI: [-0.51306, 1.73806]t-test, 1 sided
p-value: 0.01t-test, 1 sided