Recruiting

Wake and Weigh

Sponsor:

Lee Anne Siegmund

Code:

NCT07184541

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Wake and Weigh

Usual care

Study Details

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

Study ID

NCT07184541

Start date

Nov 1, 2024

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Wake and Weigh Intervention

The Wake and Weigh weight log in addition to usual care

active comparator: Control

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

Interventions

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.

Usual care

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

Primary outcome measure

  • Project Feasibility-fidelity [ Time Frame: From enrollment to the end of treatment at 4 weeks post-discharge ]
  • Project feasibility-use of tool [ Time Frame: From enrollment to the end of treatment at 4 weeks post-discharge ]
  • Project feasibility-recruitment [ Time Frame: From enrollment to the end of treatment at 4 weeks post-discharge ]
  • Project feasibility-randomization [ Time Frame: From enrollment to the end of treatment at 4 weeks post-discharge ]
  • Project feasibility-appropriateness of SCHFI [ Time Frame: From enrollment to the end of treatment at 4 weeks post-discharge ]
  • Project feasibility-appropriateness of KCCQ [ Time Frame: From enrollment to the end of treatment at 4 weeks post-discharge ]

Central Contacts and Locations

Central contacts

Lee Anne Siegmund, PhD, RN

216-618-5126siegmul@ccf.org

Kelli Falbo, MSN, RN

440-695-5494

Locations

Cleveland Clinic Avon Hospital

Recruiting

Avon, Ohio, United States, 44011

Contacts

Michelle Thomas, MSN, ACCNS-AG

216-440-8706thomasm3@ccf.org

Kelli Falbo, MSN

440-695-5494falbok@ccf.org

Principal Investigator:

Kelli Falbo, MSN

More Information

Sponsor

Lee Anne Siegmund

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lee Anne Siegmund on 2025-09-24.