NCT02635477

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2016

Geographic Reach
2 countries

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

February 13, 2017

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

October 28, 2015

Last Update Submit

February 10, 2017

Conditions

Coronary Artery DiseaseHeart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (2)

  • Quality of life

    baseline, 30 days

  • Short physical performance battery

    baseline, 30 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

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: InterventionBehavioral: Control

Interventions

InterventionBEHAVIORAL

Behavioral: actigraphy device, adaptive step count algorithm

Control GroupIntervention Group
ControlBEHAVIORAL

Behavioral: actigraphy device, step count measurement only

Control Group

Eligibility Criteria

Age70 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • older adults aged ≥70 years,
  • at least one criteria positive on the FRAIL scale,
  • hospital discharge to an independent residence,
  • primary final discharge diagnosis of coronary disease or heart failure but not requiring cardiac surgery or TAVR during the index hospitalization,
  • able to stand and walk without assistance from another person,
  • able to carry out basic activities of daily living without assistance as per Clinical Frailty Scale rating ≤5,
  • signed informed consent from the patients, and
  • approval from the treating physician that the patient is safe and appropriate to participate in this trial.

You may not qualify if:

  • cognitive impairment defined by a positive mini-cog test or known moderate or severe dementia,
  • more than one fall in the past six months, or a fall in the past three months prior to hospitalization,
  • high-risk for falls or unsteady for mobilization according to a clinical physical therapist's assessment (if performed) or as assessed during functional testing,
  • non-revascularized acute myocardial infarction within the past month (unless revascularization was not indicated) or uncorrected severe symptomatic aortic stenosis,
  • 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),
  • referral to a structured cardiac rehabilitation program in the first 30 days after hospital discharge (not counting home-based physical therapy),
  • unable to return for follow-up visit, and
  • poor comprehension of the actigraphy device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Emory University

Atlanta, Georgia, United States

RECRUITING

Boston Veterans Affairs

Boston, Massachusetts, United States

RECRUITING

Ann Arbor Veterans Affairs

Ann Arbor, Michigan, United States

RECRUITING

University of Michigan Health System

Ann Arbor, Michigan, United States

RECRUITING

Beaumont Health System/Oakwood

Dearborn, Michigan, United States

RECRUITING

St. Joseph Mercy Hospital

Ypsilanti, Michigan, United States

RECRUITING

Mayo Clinic

Rochester, New Hampshire, United States

RECRUITING

New York Presbyterian Hospital/Columbia

New York, New York, United States

RECRUITING

New York Presbyterian Hospital/Cornell

New York, New York, United States

RECRUITING

University of North Carolina

Chapel Hill, North Carolina, United States

RECRUITING

Duke University

Durham, North Carolina, United States

RECRUITING

Case Western Reserve University/University Hospital

Cleveland, Ohio, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

RECRUITING

University of Washington

Seattle, Washington, United States

RECRUITING

McGill University

Montreal, Quebec, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

RECRUITING

Related Publications (20)

  • Goldwater DS. Geriatric cardiology: a fellow's perspective. J Am Coll Cardiol. 2014 Sep 30;64(13):1401-3. doi: 10.1016/j.jacc.2014.08.009. No abstract available.

    PMID: 25257643RESULT

  • Martin SS, Ou FS, Newby LK, Sutton V, Adams P, Felker GM, Wang TY. Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials. J Am Coll Cardiol. 2013 Feb 19;61(7):762-9. doi: 10.1016/j.jacc.2012.10.046.

    PMID: 23410547RESULT

  • Gurwitz JH. The exclusion of older people from participation in cardiovascular trials. Virtual Mentor. 2014 May 1;16(5):365-8. doi: 10.1001/virtualmentor.2014.16.05.pfor1-1405. No abstract available.

    PMID: 24847706RESULT

  • Afilalo J, Eisenberg MJ, Morin JF, Bergman H, Monette J, Noiseux N, Perrault LP, Alexander KP, Langlois Y, Dendukuri N, Chamoun P, Kasparian G, Robichaud S, Gharacholou SM, Boivin JF. Gait speed as an incremental predictor of mortality and major morbidity in elderly patients undergoing cardiac surgery. J Am Coll Cardiol. 2010 Nov 9;56(20):1668-76. doi: 10.1016/j.jacc.2010.06.039.

    PMID: 21050978RESULT

  • Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

    PMID: 21205966RESULT

  • Lindman BR, Alexander KP, O'Gara PT, Afilalo J. Futility, benefit, and transcatheter aortic valve replacement. JACC Cardiovasc Interv. 2014 Jul;7(7):707-16. doi: 10.1016/j.jcin.2014.01.167. Epub 2014 Jun 18.

    PMID: 24954571RESULT

  • Afilalo J, Alexander KP, Mack MJ, Maurer MS, Green P, Allen LA, Popma JJ, Ferrucci L, Forman DE. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol. 2014 Mar 4;63(8):747-62. doi: 10.1016/j.jacc.2013.09.070. Epub 2013 Nov 27.

    PMID: 24291279RESULT

  • Forman DE, Rich MW, Alexander KP, Zieman S, Maurer MS, Najjar SS, Cleveland JC Jr, Krumholz HM, Wenger NK. Cardiac care for older adults. Time for a new paradigm. J Am Coll Cardiol. 2011 May 3;57(18):1801-10. doi: 10.1016/j.jacc.2011.02.014. No abstract available.

    PMID: 21527153RESULT

  • Riegel B, Moser DK, Anker SD, Appel LJ, Dunbar SB, Grady KL, Gurvitz MZ, Havranek EP, Lee CS, Lindenfeld J, Peterson PN, Pressler SJ, Schocken DD, Whellan DJ; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Cardiovascular Nursing; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Nutrition, Physical Activity, and Metabolism; American Heart Association Interdisciplinary Council on Quality of Care and Outcomes Research. State of the science: promoting self-care in persons with heart failure: a scientific statement from the American Heart Association. Circulation. 2009 Sep 22;120(12):1141-63. doi: 10.1161/CIRCULATIONAHA.109.192628. Epub 2009 Aug 31. No abstract available.

    PMID: 19720935RESULT

  • King AC, Haskell WL, Taylor CB, Kraemer HC, DeBusk RF. Group- vs home-based exercise training in healthy older men and women. A community-based clinical trial. JAMA. 1991 Sep 18;266(11):1535-42.

    PMID: 1880885RESULT

  • Hwang R, Marwick T. Efficacy of home-based exercise programmes for people with chronic heart failure: a meta-analysis. Eur J Cardiovasc Prev Rehabil. 2009 Oct;16(5):527-35. doi: 10.1097/HJR.0b013e32832e097f.

    PMID: 20054288RESULT

  • Tierney S, Mamas M, Woods S, Rutter MK, Gibson M, Neyses L, Deaton C. What strategies are effective for exercise adherence in heart failure? A systematic review of controlled studies. Heart Fail Rev. 2012 Jan;17(1):107-15. doi: 10.1007/s10741-011-9252-4.

    PMID: 21567221RESULT

  • Savage PD, Ades PA. Pedometer step counts predict cardiac risk factors at entry to cardiac rehabilitation. J Cardiopulm Rehabil Prev. 2008 Nov-Dec;28(6):370-7; quiz 378-9. doi: 10.1097/HCR.0b013e31818c3b6d.

    PMID: 19008690RESULT

  • Izawa KP, Watanabe S, Hiraki K, Morio Y, Kasahara Y, Takeichi N, Oka K, Osada N, Omiya K. Determination of the effectiveness of accelerometer use in the promotion of physical activity in cardiac patients: a randomized controlled trial. Arch Phys Med Rehabil. 2012 Nov;93(11):1896-902. doi: 10.1016/j.apmr.2012.06.015. Epub 2012 Jun 28.

    PMID: 22750166RESULT

  • Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.

    PMID: 18029834RESULT

  • Vaes AW, Cheung A, Atakhorrami M, Groenen MT, Amft O, Franssen FM, Wouters EF, Spruit MA. Effect of 'activity monitor-based' counseling on physical activity and health-related outcomes in patients with chronic diseases: A systematic review and meta-analysis. Ann Med. 2013 Sep;45(5-6):397-412. doi: 10.3109/07853890.2013.810891. Epub 2013 Jul 3.

    PMID: 23952917RESULT

  • Izawa KP, Watanabe S, Oka K, Hiraki K, Morio Y, Kasahara Y, Brubaker PH, Osada N, Omiya K, Shimizu H. Usefulness of step counts to predict mortality in Japanese patients with heart failure. Am J Cardiol. 2013 Jun 15;111(12):1767-71. doi: 10.1016/j.amjcard.2013.02.034. Epub 2013 Mar 27.

    PMID: 23540653RESULT

  • Cyarto EV, Myers A, Tudor-Locke C. Pedometer accuracy in nursing home and community-dwelling older adults. Med Sci Sports Exerc. 2004 Feb;36(2):205-9. doi: 10.1249/01.MSS.0000113476.62469.98.

    PMID: 14767241RESULT

  • Nguyen HQ, Steele BG, Dougherty CM, Burr RL. Physical activity patterns of patients with cardiopulmonary illnesses. Arch Phys Med Rehabil. 2012 Dec;93(12):2360-6. doi: 10.1016/j.apmr.2012.06.022. Epub 2012 Jul 5.

    PMID: 22772084RESULT

  • Leidy NK, Kimel M, Ajagbe L, Kim K, Hamilton A, Becker K. Designing trials of behavioral interventions to increase physical activity in patients with COPD: insights from the chronic disease literature. Respir Med. 2014 Mar;108(3):472-81. doi: 10.1016/j.rmed.2013.11.011. Epub 2013 Nov 20.

    PMID: 24315467RESULT

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Failure

Interventions

Methods

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Scott Hummel, MD

    University of Michigan Ann Arbor, Michigan, USA

    PRINCIPAL INVESTIGATOR

  • Jonathan Afilalo, MD, MSc

    Jewish General Hospital, McGill University, Montreal, Quebec, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Hummell, MD

CONTACT

(734) 998-7991scothumm@med.umich.edu

Jonathan Afilalo, MD, MSc

CONTACT

(514) 340 - 8222jonathan.afilalo@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2015

First Posted

December 18, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

February 13, 2017

Record last verified: 2016-11

Locations

US(14)CA(2)