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Get Going: Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults (AAIMASP)

This study is currently recruiting participants.
Verified November 2016 by American College of Cardiology
Sponsor:
ClinicalTrials.gov Identifier:
NCT02635477
First Posted: December 18, 2015
Last Update Posted: February 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Alliance for Academic Internal Medicine
Information provided by (Responsible Party):
American College of Cardiology
  Purpose
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.

Condition Intervention
Coronary Artery Disease Heart Failure Behavioral: Intervention Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Get Going: Fellow-Led Trial of an Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults Transitioning From a Cardiovascular Hospitalization to Home

Resource links provided by NLM:


Further study details as provided by American College of Cardiology:

Primary Outcome Measures:
  • Steps taken per day [ Time Frame: 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 Outcome Measures:
  • Quality of life [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment: 150
Study Start Date: January 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group
frail elderly patients discharged from a cardiovascular hospitalization; provided with an actigraphy device that displays an adaptive personalized daily step count goal and audible alerts to increase physical activity
Behavioral: Intervention
Behavioral: actigraphy device, adaptive step count algorithm
Experimental: Control Group
frail elderly patients discharged from a cardiovascular hospitalization; provided with a matching actigraphy device that has a blacked-out screen and does not display step count goals or provide audible alerts (functions in silent monitoring mode only)
Behavioral: Intervention
Behavioral: actigraphy device, adaptive step count algorithm
Behavioral: Control
Behavioral: actigraphy device, step count measurement only

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?

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years to 100 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635477


Contacts
Contact: Scott Hummell, MD (734) 998-7991 scothumm@med.umich.edu
Contact: Jonathan Afilalo, MD, MSc (514) 340 - 8222 ext 8693 jonathan.afilalo@mcgill.ca

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States
Contact: Nanette Wenger, MD       nwenger@emory.edu   
Sub-Investigator: Jane Titternington, MD         
Principal Investigator: Nanette Wenger, MD         
United States, Massachusetts
Boston Veterans Affairs Recruiting
Boston, Massachusetts, United States
Contact: Ariela Orkaby, MD       AORKABY@PARTNERS.ORG   
Principal Investigator: Ariela Orkaby, MD         
United States, Michigan
Ann Arbor Veterans Affairs Recruiting
Ann Arbor, Michigan, United States
Contact: Scott Hummel, MD       scothumm@med.umich.edu   
Sub-Investigator: Craig Albert, MD         
Principal Investigator: Scott Hummel, MD         
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States
Contact: Scott Hummell, MD       scothumm@med.umich.edu   
Sub-Investigator: Craig Alpert, MD         
Principal Investigator: Scott Hummell, MD         
Beaumont Health System/Oakwood Recruiting
Dearborn, Michigan, United States
Contact: David Sengstock, MD         
Principal Investigator: David Sengstock, MD         
Sub-Investigator: Hoda Butrous, MD         
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States
Contact: Marlo Leonen, MD       mleonen@michiganheart.com   
Principal Investigator: Marlo Leonen, MD         
Sub-Investigator: Sairia Dass Ramcharan, MD         
United States, New Hampshire
Mayo Clinic Recruiting
Rochester, New Hampshire, United States
Contact: Jorge Brenes-Salazar, MD       brenessalazar.jorge@mayo.edu   
Principal Investigator: Jorge Brenes-Salazar, MD         
Sub-Investigator: Nkechi Ijioma, MD         
United States, New York
New York Presbyterian Hospital/Columbia Recruiting
New York, New York, United States
Contact: Philip Green, MD       pg2336@cumc.columbia.edu   
Principal Investigator: Philip Green, MD         
Sub-Investigator: Christine Chung, MD         
New York Presbyterian Hospital/Cornell Recruiting
New York, New York, United States
Contact: Evelyn Horn, MD         
Sub-Investigator: Evelyn Horn, MD         
Principal Investigator: Parag Goyal, MD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States
Contact: Xuming Dai, MD       xuming_dai@med.unc.edu   
Principal Investigator: Xuming Dai, MD         
Sub-Investigator: Sarah Ciccotto, MD         
Duke University Recruiting
Durham, North Carolina, United States
Contact: Karen Alexander, MD         
Principal Investigator: Karen Alexander, MD         
Principal Investigator: Jacob Kelly, MD         
United States, Ohio
Case Western Reserve University/University Hospital Recruiting
Cleveland, Ohio, United States
Contact: Richard Josephson, MD         
Sub-Investigator: Ahmad Younes, MD         
Principal Investigator: Richard Josephson, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States
Contact: Daniel Forman, MD       formand@pitt.edu   
Principal Investigator: Daniel Forman, MD         
Sub-Investigator: Aken Desai, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States
Contact: Michael Chen, MD       michen@u.washington.edu   
Principal Investigator: Michael Chen, MD         
Sub-Investigator: Sophia Airhart, MD         
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada
Contact: Christos Galatas, MD       christos.galatas@mail.mcgill.ca   
Principal Investigator: Jonanthan Afilalo, MD         
Sub-Investigator: Christos Galatas, MD         
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Marc Jolicoeur, MD       jplicoeur@gmail.com   
Sub-Investigator: Maxime Tremblay-Gravel, MD         
Principal Investigator: Marc Jolicoeur, MD         
Sponsors and Collaborators
American College of Cardiology
Alliance for Academic Internal Medicine
Investigators
Principal Investigator: Scott Hummel, MD University of Michigan, Ann Arbor, Michigan, USA
Principal Investigator: Jonathan Afilalo, MD, MSc Jewish General Hospital, McGill University, Montreal, Quebec, Canada
  More Information

Publications:

Responsible Party: American College of Cardiology
ClinicalTrials.gov Identifier: NCT02635477     History of Changes
Other Study ID Numbers: AAIM ASP 2015
First Submitted: October 28, 2015
First Posted: December 18, 2015
Last Update Posted: February 13, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases