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NCT06479876 · Vanderbilt University Medical Center

Home-Based Cardiac Rehabilitation for Patients With Heart Failure

(MOBILE HEART)

What this study is about

The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons.

View original scientific description

The vast majority of individuals with heart failure do not participate in center based cardiac rehabilitation (CBCR). While steps to increase utilization of CBCR are important, many individuals will still not participate for a variety of reasons. This pilot randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients with heart failure. After a brief roll-in period, participants are randomized to one of two groups: (1) control or (2) HBCR mobile health intervention. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on physical activity, quality of life, clinical events, and other outcomes.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Roll-in Phase
  • Stage C HF (NYHA Class I-III) AND
  • Discharged from a HF hospitalization OR
  • Scheduled for appointment in a cardiology clinic with a prior HF hospitalization within the past 12 months OR
  • Scheduled for appointment in a cardiology clinic with a KCCQ-SS \<75
  • Receives longitudinal HF care at VUMC, including at least one visit prior to the roll-in phase Randomized Controlled Trial (beyond roll-in phase) 1\. Willingness to continue and participate in the study visits and other study activities required for the RCT

Exclusion criteria

  • Roll-in Phase
  • Unwilling or unable to provide informed consent for participation in the RCT
  • Requires a wheelchair all (or most) of the time inside and outside the house; it is acceptable if a wheelchair is needed, for example, for parking lot transfer for a clinic visit and navigating around the hospital without it being needed in the home
  • If an individual uses a walker or cane all (or most) of the time, then he/she will be excluded if he/she scores 2 or lower on the Mini-Cog or the patient is unable to perform 2 chair sit-to-stands independently or is deemed to be at high fall risk during baseline visit assessment.
  • History of falls over the last 6 months; an isolated explainable fall with no injury would not exclude the patient, but a tendency to falls indicative of balance/stability issues would exclude the patient.
  • Age \< 18 years
  • Stage D HF (advanced HF under evaluation for LVAD or transplant)
  • NYHA class IV symptoms
  • Congenital heart disease
  • Group 1 pulmonary hypertension
  • Moderate-severe or severe (\> 3+) mitral or aortic valvular disease
  • Physical or neuropsychiatric limitations that would prevent proficient use of the study tools and successful completion of the physical and quality of life assessments (e.g. blindness, dementia)
  • Planned surgery within 3 months
  • Planned discharge from hospital to hospice, assisted living, or inpatient rehabilitation facility (discharge to a senior facility permitted as long as they are considered Independent Living)
  • Treating provider or study team physician indicates that participation in the RCT would be unsafe
  • Participation in any ongoing randomized trial that has not completed follow-up Randomized Controlled Trial (beyond roll-in phase)
  • Not adherent to wearing the Actigraph activity tracker during the roll-in phase for a minimum of 4 (out of 10) compliant days (worn ³10 hours/day). Allowance will be made to include participants who wear the ActiGraph device ³10 hours/day for 3 days and also wear the ActiGraph device \>9 hours/day for at least 1 day.
  • Unable to complete the baseline study visit within 4 weeks of the completion of the roll-in actigraphy assessment.

Where

  • Nashville, Tennessee

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Sep 24, 2025 · Source of record for eligibility and locations

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1 of 100 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Nashville

Tennessee

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Heart Failure With Preserved Ejection Fraction Treatment in Nashville?

Join others in Tennessee exploring innovative treatment options through clinical research

Heart Failure With Preserved Ejection Fraction Treatment Options in Nashville, Tennessee

If you're searching for Heart Failure With Preserved Ejection Fraction treatment in Nashville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Nashville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Heart Failure With Preserved Ejection Fraction. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Tennessee
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Heart Failure With Preserved Ejection Fraction?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Heart Failure With Preserved Ejection Fraction

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Heart Failure With Preserved Ejection Fraction Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06479876. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.