Trial Outcomes & Findings for Congestive Heart Failure Weight Study (NCT NCT01185249)

NCT ID: NCT01185249

Last Updated: 2013-07-25

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

66 participants

Primary outcome timeframe

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 posted on

2013-07-25

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	66
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Patients discharged or change in status	42

Baseline Characteristics

Congestive Heart Failure Weight Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Body Weight Taken in a Standing Position n=66 Participants 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.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=39 Participants
Age, Categorical >=65 years	38 Participants n=39 Participants
Age Continuous	61 years STANDARD_DEVIATION 2.06 • n=39 Participants
Sex: Female, Male Female	28 Participants n=39 Participants
Sex: Female, Male Male	38 Participants n=39 Participants
Region of Enrollment United States	66 participants n=39 Participants
Body Weight	85.9 kilograms STANDARD_DEVIATION 1.80 • n=39 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Evening Weights n=29 Participants Patients with both morning and evening weights	Morning Weight n=29 Participants Weight of study patients in kilograms first thing in the morning.
The Measurement of the Difference Between Early Morning and Evening Weights for CHF Patients	2.47 kilograms Standard Deviation 1.80	3.09 kilograms Standard Deviation 2.06

Adverse Events

Body Weight Taken in a Standing Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alice Siehoff, Nurse Scientist

Central DuPage Hospital

Phone: 1-630-858-0260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place