NCT07184541 · Lee Anne Siegmund
A Nurse-Led Weight Monitoring Intervention For Heart Failure Quality of LIfe and Self-Care
What this study is about
Ongoing self-care for heart failure is essential to avoid complications and hospitalization. Supportive strategies are needed; however, patients with heart failure may find many interventions complicated and overwhelming.
View original scientific description
Ongoing self-care for heart failure is essential to avoid complications and hospitalization. Supportive strategies are needed; however, patients with heart failure may find many interventions complicated and overwhelming. The purpose of this pilot study is to implement a simple weight tracking tool (Wake and Weigh) to affect self-care and quality of life in a population of older adults with heart failure. This will be a randomized controlled pilot trial to test the methods to be used in a larger randomized controlled trial. The Self-care in Heart Failure Index and Kansas City Cardiomyopathy Questionnaire surveys will be given at admission and four weeks after discharge. The Wake and Weigh tool is designed to help patients track weight in the hospital and following discharge. Feasibility endpoints will be summarized descriptively.
Interventions
BEHAVIORAL
Wake and Weigh
The Wake and Weigh tool includes the patient's dry weight and instructions for daily weight monitoring. Participants in the intervention group will be instructed on the use of the tool. While in the hospital, weight is being managed by the healthcare team, so the goal during hospitalization is to educate the patient on what to do once discharged, and to recognize changes in weight.
BEHAVIORAL
Usual care
The usual care group will receive the heart failure handbook that is routinely given to heart failure patients.
Primary outcome measures
Project Feasibility-fidelity
Time frame: From enrollment to the end of treatment at 4 weeks post-discharge
Determine intervention fidelity by examining unintended variations in intervention implementation by nurse investigators
Project feasibility-use of tool
Time frame: From enrollment to the end of treatment at 4 weeks post-discharge
Evaluate use (versus no use) of the Wake and Weigh tool by participants.
Project feasibility-recruitment
Time frame: From enrollment to the end of treatment at 4 weeks post-discharge
Assess how long it takes to recruit 10% of the anticipated larger sample size
Project feasibility-randomization
Time frame: From enrollment to the end of treatment at 4 weeks post-discharge
Assess retention in each randomized group
Project feasibility-appropriateness of SCHFI
Time frame: From enrollment to the end of treatment at 4 weeks post-discharge
Determine percentage of completed SCHFIs
Project feasibility-appropriateness of KCCQ
Time frame: From enrollment to the end of treatment at 4 weeks post-discharge
Determine percentage of completed KCCQs
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Must be able to stand and weigh independently.
- Must have a scale at home, or ability to obtain one for the study.
Exclusion criteria
- 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).
Where
- Avon, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2025 · Source of record for eligibility and locations