A Nurse-Led Weight Monitoring Intervention For Heart Failure Quality of LIfe and Self-Care
The Effect of a Nurse-led Daily Weight Monitoring Intervention (Wake and Weigh) on Heart Failure Quality of Life and Self-care
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 55 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 weeks
- Procedures mentioned: Questionnaires, Phone or video check-ins
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The Self-care in Heart Failure Index and Kansas City Cardiomyopathy Questionnaire surveys will be given at admission and four weeks after discharge."
- "During the post-intervention phone call, the nurse investigator will ask the participant about Wake and Weigh use (see follow-up calls document)."
- "Randomization and retention feasibility will be determined by the percentage of participants who stay in the assigned group and in the study until completion of exit surveys."
- "If 70% or more of the control group and 70% or more of the intervention group remain in the study for two weeks or until study follow-up call, randomization will be considered feasible."
- "If 70% or more of all participants remain in the study for two weeks or until study follow-up call, retention will be considered feasible. 4."
- "The appropriateness of the instruments and instrument scores will be determined with internal consistency, percentage of completed surveys (80% of participants complete both surveys=appropriate for a larger study), and survey inter-correlations (surveys correlated at \< 0.3)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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).
Study sites (1)
OH
- Cleveland Clinic Avon Hospital · Avon, OH 44011Michelle Thomas, MSN, ACCNS-AG · Study contact · 216-440-8706 · thomasm3@ccf.orgKelli Falbo, MSN · Study contact · 440-695-5494 · falbok@ccf.orgKelli Falbo, MSN · Principal investigatorBrenda Miller, RN · Sub-investigatorMore trials in Avon