Coronary Artery Disease, Heart Failure
Conditions
Brief summary
A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization.
Detailed description
The transition from hospital to home is critical for older patients after a cardiovascular hospitalization, since 1 in 3 will suffer the fate of functional decline or repeat hospitalizations within the first 30 days. This has a tremendous impact on the patient, leading to a vicious cycle of worsening health status and disability, and the healthcare system, leading to an estimated $12 billion of preventable costs. At the policy level, preventing readmissions has become a national priority at the forefront of the medical agenda. Frailty, a geriatric syndrome characterized by subclinical impairments in multiple organs and decreased physiologic resiliency, is a major risk factor for unsuccessful transitions of care and adverse health outcomes. Thus, it has been suggested that interventions aimed at improving transitions of care should target frail patients. Frail individuals demonstrate a well-defined phenotype of muscle weakness and physical inactivity, readily measurable using various scales and instruments. To date, the most widely studied intervention to improve frailty and related outcomes has been physical activity. However, fewer than 50% of patients adhere to regular physical activity programs. Enrollment in cardiac rehabilitation programs is even lower owing to multiple barriers, including lack of payer reimbursement ≤ 30 days after a hospitalization, the highest risk period for readmissions. Scientific statements have called for augmented self-care to assure adequate physical activity in patients with heart failure and other forms of cardiovascular disease 10. Moreover, low-intensity home-based physical activity programs can be as efficacious as higher-intensity center-based programs, strengthening the rationale for self-care. The advent of small, portable, inexpensive accelerometer devices has emerged as a powerful tool to facilitate self-monitored physical activity. These devices are worn by patients and provide real-time feedback about the number of steps walked each day (as well as other functional parameters). This is in tune with a systematic review which found that feedback and goal setting improved adherence to physical activity in patients with heart failure. A few studies in the physical therapist literature have used accelerometers to demonstrate low baseline physical activity and boost total step counts in patients attending cardiac rehabilitation, but these patients were at least 30 days removed from their index hospitalization, and none enrolled patients in the critical post-discharge phase. Research question: Is a portable actigraphy-based intervention more effective than standard-of-care in promoting physical activity in the first 30 days after hospital discharge among frail older adults with cardiovascular disease?
Interventions
BEHAVIORALIntervention
Behavioral: actigraphy device, adaptive step count algorithm
BEHAVIORALControl
Behavioral: actigraphy device, step count measurement only
Sponsors
Alliance for Academic Internal Medicine
American College of Cardiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. older adults aged ≥70 years, 2. at least one criteria positive on the FRAIL scale, 3. hospital discharge to an independent residence, 4. primary final discharge diagnosis of coronary disease or heart failure but not requiring cardiac surgery or TAVR during the index hospitalization, 5. able to stand and walk without assistance from another person, 6. able to carry out basic activities of daily living without assistance as per Clinical Frailty Scale rating ≤5, 7. signed informed consent from the patients, and 8. approval from the treating physician that the patient is safe and appropriate to participate in this trial.
Exclusion criteria
1. cognitive impairment defined by a positive mini-cog test or known moderate or severe dementia, 2. more than one fall in the past six months, or a fall in the past three months prior to hospitalization, 3. high-risk for falls or unsteady for mobilization according to a clinical physical therapist's assessment (if performed) or as assessed during functional testing, 4. non-revascularized acute myocardial infarction within the past month (unless revascularization was not indicated) or uncorrected severe symptomatic aortic stenosis, 5. active severe symptoms of angina, dyspnea, or claudication at rest or with minimal activity (Canadian Cardiovascular Society class 4, New York Heart Association class 4, or Fontaine class 3-4, respectively), 6. referral to a structured cardiac rehabilitation program in the first 30 days after hospital discharge (not counting home-based physical therapy), 7. unable to return for follow-up visit, and 8. poor comprehension of the actigraphy device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps taken per day | 1 year | The primary outcome measure for this study is the average number of steps walked per day during the study period (excluding the run-in phase), as determined by the actigraphy device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | baseline, 30 days | A secondary outcome for this study is quality of life, as determined by score on the EQ-5D questionnaire |
| Short physical performance battery | baseline, 30 days | A secondary outcome for this study is physical performance, as determined by the change in Short Physical Performance Battery score from baseline to 30-days. |
Countries
Canada, United States
Contacts
Primary ContactScott Hummell, MD
Backup ContactJonathan Afilalo, MD, MSc
Outcome results
None listed