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

February 10, 2017 updated by: American College of Cardiology

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Montreal Heart Institute
        • Contact:
        • Sub-Investigator:
          • Maxime Tremblay-Gravel, MD
        • Principal Investigator:
          • Marc Jolicoeur, MD
      • Montreal, Quebec, Canada
        • Recruiting
        • McGill University
        • Contact:
        • Principal Investigator:
          • Jonanthan Afilalo, MD
        • Sub-Investigator:
          • Christos Galatas, MD
  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Recruiting
        • Emory University
        • Contact:
        • Sub-Investigator:
          • Jane Titternington, MD
        • Principal Investigator:
          • Nanette Wenger, MD
    • Massachusetts
      • Boston, Massachusetts, United States
        • Recruiting
        • Boston Veterans Affairs
        • Contact:
        • Principal Investigator:
          • Ariela Orkaby, MD
    • Michigan
      • Ann Arbor, Michigan, United States
        • Recruiting
        • Ann Arbor Veterans Affairs
        • Principal Investigator:
          • Scott Hummel, MD
        • Contact:
        • Sub-Investigator:
          • Craig Albert, MD
      • Ann Arbor, Michigan, United States
        • Recruiting
        • University of Michigan Health System
        • Contact:
        • Sub-Investigator:
          • Craig Alpert, MD
        • Principal Investigator:
          • Scott Hummell, MD
      • Dearborn, Michigan, United States
        • Recruiting
        • Beaumont Health System/Oakwood
        • Contact:
          • David Sengstock, MD
        • Principal Investigator:
          • David Sengstock, MD
      • Ypsilanti, Michigan, United States
        • Recruiting
        • St. Joseph Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Marlo Leonen, MD
        • Sub-Investigator:
          • Sairia Dass Ramcharan, MD
    • New Hampshire
      • Rochester, New Hampshire, United States
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Jorge Brenes-Salazar, MD
        • Sub-Investigator:
          • Nkechi Ijioma, MD
    • New York
      • New York, New York, United States
        • Recruiting
        • New York Presbyterian Hospital/Columbia
        • Sub-Investigator:
          • Christine Chung, MD
        • Contact:
        • Principal Investigator:
          • Philip Green, MD
      • New York, New York, United States
        • Recruiting
        • New York Presbyterian Hospital/Cornell
        • Sub-Investigator:
          • Evelyn Horn, MD
        • Contact:
          • Evelyn Horn, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Recruiting
        • University of North Carolina
        • Contact:
        • Sub-Investigator:
          • Sarah Ciccotto, MD
      • Durham, North Carolina, United States
        • Recruiting
        • Duke University
        • Contact:
          • Karen Alexander, MD
        • Principal Investigator:
          • Karen Alexander, MD
        • Principal Investigator:
          • Jacob Kelly, MD
    • Ohio
      • Cleveland, Ohio, United States
        • Recruiting
        • Case Western Reserve University/University Hospital
        • Contact:
          • Richard Josephson, MD
        • Sub-Investigator:
          • Ahmad Younes, MD
        • Principal Investigator:
          • Richard Josephson, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Recruiting
        • University of Pittsburgh
        • Contact:
    • Washington
      • Seattle, Washington, United States
        • Recruiting
        • University of Washington
        • Contact:
        • Principal Investigator:
          • Michael Chen, MD
        • Sub-Investigator:
          • Sophia Airhart, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 30 days
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.
baseline, 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American College of Cardiology

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

February 13, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAIM ASP 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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