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.
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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
Behavioral: actigraphy device, adaptive step count algorithm
Behavioral: actigraphy device, step count measurement only
Emory University
Atlanta, Georgia, United States
RECRUITINGBoston Veterans Affairs
Boston, Massachusetts, United States
Steps taken per day
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.
Time frame: 1 year
Quality of life
A secondary outcome for this study is quality of life, as determined by score on the EQ-5D questionnaire
Time frame: baseline, 30 days
Short physical performance battery
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.
Time frame: baseline, 30 days
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Ann Arbor Veterans Affairs
Ann Arbor, Michigan, United States
RECRUITINGUniversity of Michigan Health System
Ann Arbor, Michigan, United States
RECRUITINGBeaumont Health System/Oakwood
Dearborn, Michigan, United States
RECRUITINGSt. Joseph Mercy Hospital
Ypsilanti, Michigan, United States
RECRUITINGMayo Clinic
Rochester, New Hampshire, United States
RECRUITINGNew York Presbyterian Hospital/Columbia
New York, New York, United States
RECRUITINGNew York Presbyterian Hospital/Cornell
New York, New York, United States
RECRUITINGUniversity of North Carolina
Chapel Hill, North Carolina, United States
RECRUITING...and 6 more locations