A Nurse-Led Weight Monitoring Intervention For Heart Failure Quality of LIfe and Self-Care
Part of paid clinical trials in Avon, Ohio.
- Sponsor
- Lee Anne Siegmund
- Study ID
- NCT07184541
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 55 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Wake and Weigh — BEHAVIORALThe 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 — BEHAVIORALThe usual care group will receive the heart failure handbook that is routinely given to heart failure patients.
Study Details
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.
Key Dates
- Start date
- Nov 1, 2024
- Status verified
- Sep 2025
- Primary completion
- Oct 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 42 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Wake and Weigh InterventionThe Wake and Weigh weight log in addition to usual care
- Active Comparator: ControlThe heart failure handbook (routinely given for first heart failure admission), and heart failure education per usual care
Primary Outcome Measure
Project Feasibility-fidelity [ Time Frame: From enrollment to the end of treatment at 4 weeks post-discharge ]
Central Contacts
- Lee Anne Siegmund, PhD, RN216-618-5126
- Kelli Falbo, MSN, RN440-695-5494
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cleveland Clinic Avon Hospital | Avon | Ohio | 44011 | Kelli Falbo, MSN (PRINCIPAL_INVESTIGATOR) Brenda Miller, RN (SUB_INVESTIGATOR) Jane Painter, BSN (SUB_INVESTIGATOR) Michelle Thomas, MSN (SUB_INVESTIGATOR) Anna Cole, BSN (SUB_INVESTIGATOR) Linda Turner, MSN (SUB_INVESTIGATOR) Lee Anne Siegmund, PhD, RN (SUB_INVESTIGATOR) |
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