Home-Based Cardiac Rehabilitation for Patients With Heart Failure

Official title

Home-Based Cardiac Rehabilitation Using Mobile Health Tools for Patients With Heart Failure (MOBILE HEART): A Randomized Controlled Trial

Overview

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.

Interventions

• Other HBCR
  Home-based cardiac rehabilitation intervention facilitated by a custom app to deliver education, counseling on healthy living and modification of risk factors, mindfulness, and physical activity guidance. Additionally, there are periodic video calls with an exercise physiologist.

Primary outcome measures

• Average daily total activity counts [Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily total activity counts determined. The primary comparison will be at 12 weeks after randomization.]

Secondary outcome measures (12)

• Average daily active minutes [Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily activity minutes determined. The comparison will be at 12 weeks after randomization.]
• Average daily steps [Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.]
• Average daily energy expenditure [Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily energy expenditure determined. The comparison will be at 12-weeks after randomization.]
• Average daily moderate to vigorous active minutes [Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily moderate to vigorous active mins determined. The comparison will be at 12-weeks after randomization.]
• Sustained physical activity bursts of 10 minutes or greater per day [Time frame: The actigraphy device will be worn for approximately one week and, using data from days when the device was worn >10 hours, the average daily steps determined. The comparison will be at 12 weeks after randomization.]
• 6 minute walk distance [Time frame: The comparison will be at 12-weeks after randomization.]
• Chair sit to stand time [Time frame: The comparison will be at 12-weeks after randomization.]
• 5 meter gait speed [Time frame: The comparison will be at 12-weeks after randomization.]
• Balance test [Time frame: The comparison will be at 12-weeks after randomization.]
• AM-PAC Basic Mobility Outpatient Short Form (Low Function) [Time frame: The comparison will be at 12-weeks after randomization.]
• Short Physical Performance Battery Score [Time frame: The comparison will be at 12-weeks after randomization.]
• Heart-failure specific health status assessed by the KCCQ [Time frame: The comparison will be at 12-weeks after randomization.]

Eligibility criteria

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
• Pregnant
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT06479876 · 240749

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗