Congestive Heart FailureNCT01185249
Congestive Heart Failure Weight Study
A study testing Weigh subjects on a scale in the standing position in people with Congestive Heart Failure, run by Central DuPage Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Weigh subjects on a scale in the standing position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Congestive Heart Failure
- Being tested
- Weigh subjects on a scale in the standing position
- Keywords
- CHF, congestive heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weigh subjects on a scale in the standing positionProcedure or surgery
Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Weigh subjects on a scale in the standing position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central DuPage Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice M Siehoff, DNP, RN-BC, Principal investigator, Central DuPage Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185249
- Sponsor's protocol ID
- 10-010
- Status last verified
- Jun 2013
- First submitted
- 18 Aug 2010
- Last updated
- 25 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Day and Accurate Weights for Patients With Congestive Heart Failure (CHF)
- ClinicalTrials.gov ID
- NCT01185249
- Acronym / sponsor ID
- 10-010
- Conditions
- Congestive Heart Failure
- Keywords
- CHF, congestive heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Central DuPage HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Posted 25 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body weight taken in a standing position | Experimental | Procedure: Weigh subjects on a scale in the standing positionSubjects 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weigh subjects on a scale in the standing positionSubjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized. | Procedure or surgery | Body weight taken in a standing position |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice M Siehoff, DNP, RN-BC principal investigator
Central DuPage Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weigh subjects on a scale in the standing position in people with Congestive Heart Failure, run by Central DuPage Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.