RecruitingNot Applicable

A Nurse-Led Weight Monitoring Intervention For Heart Failure Quality of LIfe and Self-Care

United States42 participantsStarted 2024-11-01

Plain-language 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.

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Project Feasibility-fidelity

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-use of tool

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-recruitment

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-randomization

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-appropriateness of SCHFI

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-appropriateness of KCCQ

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Trial details

NCT IDNCT07184541

SponsorLee Anne Siegmund

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Lee Anne Siegmund, PhD, RN

216-618-5126 siegmul@ccf.org

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Project Feasibility-fidelity

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-use of tool

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-recruitment

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-randomization

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-appropriateness of SCHFI

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge

Project feasibility-appropriateness of KCCQ

Timeframe: From enrollment to the end of treatment at 4 weeks post-discharge