Recruiting

Wake and Weigh Tool for Heart Failure Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Wake and Weigh

+ Usual care

Behavioral
Who is being recruted

Body Weight+3

+ Cardiovascular Diseases

+ Heart Diseases

Over 55 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: November 2024
See protocol details

Summary

Principal SponsorLee Anne Siegmund
Study ContactLee Anne Siegmund, PhD, RNMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2024

Actual date on which the first participant was enrolled.

This study aims to see if a daily weight tracking tool, called the Wake and Weigh, can help improve self-care and quality of life for people aged 55 and older living with heart failure. Heart failure can make it hard for people to manage their health because they might feel overwhelmed by symptoms and complicated instructions. This tool is a simple way for patients to monitor their weight daily, which can help them recognize important changes in their health. The study is being conducted at a hospital in Ohio and focuses on whether this approach can be effective on a larger scale to support older adults in managing their heart failure more effectively. Participants in the study will be given the Wake and Weigh tool during their hospital stay and will be taught by nurses how to use it. The tool is a paper chart where patients record their morning weight daily. It helps patients learn to notice any significant weight changes, which can be a sign of their condition getting worse. The study will track how well participants use the tool, their self-care behaviors, and how their quality of life improves. The results will help determine if this approach is practical for a larger study and if it can truly help people manage heart failure better at home after they leave the hospital.

Official TitleThe Effect of a Nurse-led Daily Weight Monitoring Intervention (Wake and Weigh) on Heart Failure Quality of Life and Self-care
NCT07184541
Principal SponsorLee Anne Siegmund
Study ContactLee Anne Siegmund, PhD, RNMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightCardiovascular DiseasesHeart DiseasesHeart FailureSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

6 inclusion criteria required to participate
Adults (55 years or older)
New or existing diagnosis of HF (regardless of type or length of time since diagnosis).
Being treated for HF signs and/or symptoms during the current hospitalization (any of the following: IV diuretic, fluid restriction, low sodium diet).
Must be able to read and communicate in English.
Show More Criteria
2 exclusion criteria prevent from participating
Documented diagnosis of cognitive impairment.
A Charlson Comorbidity Index (CCI) of >4. This was chosen to exclude patients more likely to have hospital stays longer than a week. A CCI of >3 was based on research showing a relationship to mortality (Imam et al., 2020), a CCI of ≥ 6 with a 2.8-times higher mortality (Yilmaz & Omurlu, 2019), and likelihood of longer hospital length of stay for patients with HF if CCI >2 (Foraker et al., 2014).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The Wake and Weigh weight log in addition to usual care

Group II

Active Comparator
The heart failure handbook (routinely given for first heart failure admission), and heart failure education per usual care

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Cleveland Clinic Avon Hospital

Avon, United StatesOpen Cleveland Clinic Avon Hospital in Google Maps
Recruiting
One Study Center