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REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease (RESILIENT)

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ClinicalTrials.gov Identifier: NCT03978130
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
RESILIENT is a phase III, multi-center, prospective, pragmatic randomized clinical trial with blinded assessment of the primary endpoint. This study aims to evaluate whether mHealth-CR improves functional capacity in older adults (age =70) with IHD compared with standard traditional cardiac rehabilitation care. A total of 400 eligible patients will be randomized in 3:1 manner to mHealth-CR versus usual care for assessment of primary endpoint. Enrollment will occur over approximately 42 months with an expected minimum of 3 months follow-up per participant.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Behavioral: Weekly Activities of Daily Living Behavioral: Usual Care Not Applicable

Detailed Description:
The primary objective of RESILIENT is to evaluate whether mobile health cardiac rehab (mHealth-CR) improves functional capacity in older adults (age =70) with ischemic heart disease (IHD), identified at the time of acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG), compared with usual care. Our central hypotheses related to efficacy are that mHealth-CR will (1) improve functional capacity (primary outcome), (2) improve goal attainment, health status, and activities of daily living, and (3) lower rates of hospital readmission and death (secondary outcomes). Our central hypothesis related to engagement is that we will identify distinct trajectories of engagement and characteristics that predict membership in each category.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: REhabilitation at Home uSIng mobiLe Health In oldEr Adults After hospitalizatioN for Ischemic hearT Disease
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mHealth-CR Behavioral: Weekly Activities of Daily Living
Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device.

Active Comparator: Usual Care Behavioral: Usual Care
Participants randomized to the usual care group will receive a tablet computer in order to complete the weekly ADL assessment.




Primary Outcome Measures :
  1. Change in the 6MWD between Baseline and 3 Month Follow Up [ Time Frame: 3 Months ]
    Change in 6MWD, reflective of functional capacity, is measured by the 6-minute walk test (6MWT). The 6MWT will be performed during baseline hospitalization and at the 3-month follow-up visit by a blinded research nurse.


Secondary Outcome Measures :
  1. Goal Attainment as measured by goal attainment scaling (GAS) [ Time Frame: 3 Months ]
    defined as whether a person's individual functional goals are achieved as a result of the study intervention, measured using a 5-point goal attainment scale



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 110 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized for AMI, PCI, or CABG.
  • Capable of self-consent.
  • Understand and are able to perform study procedures (i.e. 6-minute walk test, use mHealth in English or Spanish).

Exclusion Criteria:

  • Non-ambulatory.
  • Moderate or severe cognitive impairment.
  • Unable/unwilling to consent.
  • PCI-related groin hematoma that precludes brisk walking.
  • Incarcerated.
  • Unable to use mHealth software in English or Spanish.
  • Severe osteoarthritis, or joint replacement within last 3 months.
  • Parkinson's disease or other progressive movement disorder.
  • Regular use of walker for ambulation.
  • Projected life expectancy <3 months.
  • Clinical judgment concerning other safety or nonadherence issues.
  • Participants admitted from a long-term care facility.

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): NCT03978130


Contacts
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Contact: Jenny Summapund (646) 501-2646 Jenny.Summapund@nyulangone.org

Locations
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United States, New York
NYU Langone Health Not yet recruiting
New York, New York, United States, 10016
Contact: Jenny Summapund, MA    646-501-2646    jenny.summapund@nyumc.org   
Principal Investigator: John Dodson, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: John Dodson, MD New York Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03978130     History of Changes
Other Study ID Numbers: 18-02017
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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