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

NCT07184541 | Recruiting

• 1 other identifier: 23-976
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Self-care; Quality of life; Weight

Outcome Measures

Primary Outcomes (6)

• Project Feasibility-fidelity

  Determine intervention fidelity by examining unintended variations in intervention implementation by nurse investigators

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

• Project feasibility-use of tool

  Evaluate use (versus no use) of the Wake and Weigh tool by participants.

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

• Project feasibility-recruitment

  Assess how long it takes to recruit 10% of the anticipated larger sample size

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

• Project feasibility-randomization

  Assess retention in each randomized group

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

• Project feasibility-appropriateness of SCHFI

  Determine percentage of completed SCHFIs

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

• Project feasibility-appropriateness of KCCQ

  Determine percentage of completed KCCQs

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

Secondary Outcomes (2)

• Heart Failure Quality of Life

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

• Heart Failure Self-care

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

Study Arms (2)

Wake and Weigh Intervention

ACTIVE COMPARATOR

The Wake and Weigh weight log in addition to usual care

Behavioral: Wake and Weigh

Control

ACTIVE COMPARATOR

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

Behavioral: Usual care

Interventions

Wake and Weigh BEHAVIORAL

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.

Wake and Weigh Intervention

Usual care BEHAVIORAL

The usual care group will receive the heart failure handbook that is routinely given to heart failure patients.

Control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lee Anne Siegmund: lead

Study Sites (1)

Cleveland Clinic Avon Hospital

Avon, Ohio, 44011, United States

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Heart Failure; Body Weight

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lee Anne Siegmund, PhD, RN

CONTACT

216-618-5126; siegmul@ccf.org

Kelli Falbo, MSN, RN

CONTACT

440-695-5494

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Nurse Scientist

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: September 22, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)