Recruiting

Accelerometer-Based Intervention

Sponsor:

American College of Cardiology

Code:

NCT02635477

Conditions

Coronary Artery Disease

Heart Failure

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Intervention

Control

Study Details

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.

Conditions

Coronary Artery Disease

Heart Failure

Study ID

NCT02635477

Start date

Jan, 2016

Status verified date

Nov, 2016

Completion date

Nov, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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)

Interventions

Intervention

Behavioral: actigraphy device, adaptive step count algorithm

Control

Behavioral: actigraphy device, step count measurement only

Primary outcome measure

  • Steps taken per day [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Emory University

Recruiting

Atlanta, Georgia, United States

Contacts

Nanette Wenger, MD

nwenger@emory.edu

Principal Investigator:

Nanette Wenger, MD

Boston Veterans Affairs

Recruiting

Boston, Massachusetts, United States

Contacts

Ariela Orkaby, MD

AORKABY@PARTNERS.ORG

Principal Investigator:

Ariela Orkaby, MD

Ann Arbor Veterans Affairs

Recruiting

Ann Arbor, Michigan, United States

Contacts

Scott Hummel, MD

scothumm@med.umich.edu

Principal Investigator:

Scott Hummel, MD

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States

Contacts

Scott Hummell, MD

scothumm@med.umich.edu

Principal Investigator:

Scott Hummell, MD

Beaumont Health System/Oakwood

Recruiting

Dearborn, Michigan, United States

Principal Investigator:

David Sengstock, MD

St. Joseph Mercy Hospital

Recruiting

Ypsilanti, Michigan, United States

Contacts

Principal Investigator:

Marlo Leonen, MD

Mayo Clinic

Recruiting

Rochester, New Hampshire, United States

Contacts

Jorge Brenes-Salazar, MD

brenessalazar.jorge@mayo.edu

Principal Investigator:

Jorge Brenes-Salazar, MD

New York Presbyterian Hospital/Columbia

Recruiting

New York, New York, United States

Contacts

Philip Green, MD

pg2336@cumc.columbia.edu

Principal Investigator:

Philip Green, MD

New York Presbyterian Hospital/Cornell

Recruiting

New York, New York, United States

Principal Investigator:

Parag Goyal, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States

Contacts

Principal Investigator:

Xuming Dai, MD

Duke University

Recruiting

Durham, North Carolina, United States

Principal Investigator:

Karen Alexander, MD

Case Western Reserve University/University Hospital

Recruiting

Cleveland, Ohio, United States

Principal Investigator:

Richard Josephson, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States

Contacts

Daniel Forman, MD

formand@pitt.edu

Principal Investigator:

Daniel Forman, MD

University of Washington

Recruiting

Seattle, Washington, United States

Contacts

Michael Chen, MD

michen@u.washington.edu

Principal Investigator:

Michael Chen, MD

McGill University

Recruiting

Montreal, Quebec, Canada

Contacts

Principal Investigator:

Jonanthan Afilalo, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada

Contacts

Marc Jolicoeur, MD

jplicoeur@gmail.com

Principal Investigator:

Marc Jolicoeur, MD

More Information

Sponsor

American College of Cardiology

Last update posted

Feb 13, 2017

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by American College of Cardiology on 2017-02-13.