NCT07184541 A Nurse-Led Weight Monitoring Intervention For Heart Failure Quality of LIfe and Self-Care
| NCT ID | NCT07184541 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lee Anne Siegmund |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2024-11-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults (55 years or older) 2. New or existing diagnosis of HF (regardless of type or length of time since diagnosis). 3. Being treated for HF signs and/or symptoms during the current hospitalization (any of the following: IV diuretic, fluid restriction, low sodium diet). 4. Must be able to read and communicate in English. 5. Must be able to stand and weigh independently. 6. Must have a scale at home, or ability to obtain one for the study. Exclusion Criteria: 1. Documented diagnosis of cognitive impairment. 2. 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07184541 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07184541 currently recruiting?
Yes, NCT07184541 is actively recruiting participants. Contact the research team at siegmul@ccf.org for enrollment information.
Where is the NCT07184541 trial being conducted?
This trial is being conducted at Avon, United States.
Who is sponsoring the NCT07184541 clinical trial?
NCT07184541 is sponsored by Lee Anne Siegmund. The trial plans to enroll 42 participants.
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