RECRUITING

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

Conditions

Heart Failure Self-care Quality of life Weight

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Effect of a Nurse-led Daily Weight Monitoring Intervention (Wake and Weigh) on Heart Failure Quality of Life and Self-care

Quick Facts

Study Start:2024-11-01

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07184541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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).

Inclusion Criteria

Exclusion 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.

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).

Contacts and Locations

Study Contact

Lee Anne Siegmund, PhD, RN

CONTACT

216-618-5126

siegmul@ccf.org

Kelli Falbo, MSN, RN

CONTACT

440-695-5494

Study Locations (Sites)

Cleveland Clinic Avon Hospital

Avon, Ohio, 44011

United States

Collaborators and Investigators

Sponsor: Lee Anne Siegmund

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Heart Failure
Self-care
Quality of life
Weight

Additional Relevant MeSH Terms

Heart Failure