Wake and Weigh for Heart Failure

Overseen By Lee Anne Siegmund, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lee Anne Siegmund

Disqualifiers: Cognitive impairment, CCI > 4, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to ease life for older adults with heart failure by using a simple tool called Wake and Weigh. This tool helps patients track their weight daily, which is crucial for managing heart failure and avoiding hospital visits. Participants will be divided into two groups: one using Wake and Weigh alongside usual care, and the other receiving standard heart failure care. The trial seeks adults aged 55 or older who have heart failure and are currently receiving hospital treatment. Participants must be able to read English, weigh themselves independently, and have access to a home scale. As an unphased trial, this study offers participants the chance to contribute to innovative heart failure management strategies that could improve daily life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using a weight tracking tool for heart failure management.

What prior data suggests that the Wake and Weigh tool is safe for heart failure patients?

Research has shown that tracking weight can safely and effectively help manage heart failure. The Wake and Weigh tool offers an easy way for patients to monitor their weight, which is crucial because sudden weight changes might signal heart failure issues.

Previous studies on weight monitoring for heart failure have found this method to be safe and generally well-accepted by patients. The tool is simple to use and does not involve medication or complicated procedures, reducing the risk of side effects.

Although this trial is in the early stages and tests the practicality of the Wake and Weigh tool, existing research supports the concept of weight monitoring for heart failure management. It aims to help patients care for themselves without adding stress or confusion. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Researchers are excited about the 'Wake and Weigh' approach for heart failure because it emphasizes daily weight monitoring as a proactive management tool. Unlike traditional treatments that focus heavily on medication and lifestyle changes, this method encourages patients to log their weight each morning, allowing for early detection of fluid retention. This simple routine empowers patients to take an active role in their care and may help prevent hospital readmissions by catching symptoms early. By integrating this daily practice with usual care, the hope is to enhance patient outcomes and provide an accessible, low-cost addition to heart failure management."

What evidence suggests that the Wake and Weigh tool is effective for heart failure?

Research has shown that daily weight tracking can significantly improve self-care in people with heart failure. In this trial, participants in the "Wake and Weigh Intervention" arm will use the Wake and Weigh tool, which studies have found helps patients manage their condition by increasing awareness of weight changes. Regular weight checks can catch problems early, reducing the risk of complications and hospital visits. The Self-Care of Heart Failure Index (SCHFI) often assesses how well patients manage their care. Similarly, the Kansas City Cardiomyopathy Questionnaire measures quality of life, indicating that better self-management can enhance life with heart failure. Overall, these findings suggest that the Wake and Weigh tool can help patients stay healthier and avoid complications. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for older adults with heart failure and obesity who can follow a simple weight tracking routine. It's not specified who can't join, but typically those unable to comply or at risk of non-adherence might be excluded.

Inclusion Criteria

Must be able to read and communicate in English

Must have a scale at home, or ability to obtain one for the study

I have been diagnosed with heart failure.

Exclusion Criteria

Documented diagnosis of cognitive impairment

My health conditions are not likely to cause a hospital stay longer than a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Introduction and implementation of the Wake and Weigh tool for heart failure patients

4 weeks

Daily use during hospital stay, follow-up calls at 2 and 4 weeks post-discharge

Follow-up

Participants are monitored for the use of the Wake and Weigh tool and changes in heart failure self-care and quality of life

4 weeks

Phone follow-up at 2 and 4 weeks post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• Wake and Weigh

Trial Overview The study tests 'Wake and Weigh', a straightforward daily weight monitoring tool against usual care in managing heart failure. Participants are randomly assigned to either the new tool or standard practices to compare effects on self-care and life quality.

How Is the Trial Designed?

Group I: Wake and Weigh Intervention Active Control 1 Intervention

The Wake and Weigh weight log in addition to usual care

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Lee Anne Siegmund

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07184541

A Nurse-Led Weight Monitoring Intervention For Heart ... Heart failure quality of life will be collected using Kansas City Cardiomyopathy Questionnaire-12. This 12-item questionnaire uses a Likert scale from 1-5 (1 = ...

2. ichgcp.net ichgcp.net/clinical-trials-registry/553837-a-nurse-led-weight-monitoring-intervention-for-heart-failure-quality-of-life-and-self-care

Wake and Weigh: Nurse-Led Daily Weight Monitoring Study ... They will also use two standardized questionnaires to measure outcomes: the Self-Care of Heart Failure Index (SCHFI) to assess daily self-care ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11780297/

Patient-Centered mHealth Intervention to Improve Self-Care in ... Primary Efficacy Outcome Measure. The primary efficacy outcome measure was self-reported HF self-care assessed with the Self-Care Heart Failure Index (SCHFI; ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S245186542200134X

Effectiveness of daily activity record-based self-monitoring ... The primary outcome is participants' “Asking for Help” dimension of self-care behavior, measured using the European Heart Failure Self-Care Behavior Scale at ...

5. jmir.org jmir.org/2020/7/e17559/

The Effects of Telemonitoring on Patient Compliance With ... Background: Telemonitoring enables care providers to remotely support outpatients in self-managing chronic heart failure (CHF), ...

6. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2772982

Effect of a Self-care Intervention on 90-Day Outcomes in ... These data suggest that a self-care management plan does not impact 90-day events but may provide short-term improvements in heart failure outcomes and health ...

7. tenovi.com tenovi.com/congestive-heart-failure-weight-monitoring/

Weight Monitoring for Congestive Heart Failure In this post, you'll review the risks of congestive heart failure and the benefits of CHF weight monitoring for congestive heart failure.