Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure
NCT ID: NCT03035474
Last Updated: 2021-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5749 participants
INTERVENTIONAL
2017-04-21
2020-12-31
Brief Summary
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Detailed Description
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The health-system QI program will involve site visits and ongoing mentoring from teams of healthcare professionals with specialized training and field experience to help health systems and individual hospitals to design local QI plans.
A key substudy will assess a participant-engagement strategy (digital) of a mobile application utilizing behavioral tools to reinforce health behaviors, including self-monitoring/self-management and medication adherence.
Follow-up will occur via a centralized telephone interview by trained personnel via the DCRI Call Center. At each interview, participants will be asked to report current medications, rehospitalizations, and QOL assessments. Based on participant-reported events, medical billing data for rehospitalizations, emergency department visits, and procedures will be obtained.
Quality of life assessments will include the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQOL five dimensions questionnaire (EQ-5D).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
NONE
Study Groups
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Direct & Digital
Health system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence
Digital Engagement
Patient engagement to improve self-management/medication adherence
Direct Engagement
Health system engagement to improve local QI programs
Direct & Registry
Health system engagement to improve local QI programs and patient and control
Direct Engagement
Health system engagement to improve local QI programs
Digital & Registry
Patient engagement to improve self-management/medication adherence and control
Digital Engagement
Patient engagement to improve self-management/medication adherence
Registry
Control
No interventions assigned to this group
Interventions
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Digital Engagement
Patient engagement to improve self-management/medication adherence
Direct Engagement
Health system engagement to improve local QI programs
Eligibility Criteria
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Inclusion Criteria
* Acute HF as a primary cause of hospitalization
* Hospitalizations for acute HF will be determined by local clinician-investigators but should include the following:
* Symptoms (eg, dyspnea, fatigue), signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the hospitalization and
* Treatments aimed at acute HF (eg, intravenous diuretics, vasodilators, or inotropes)
* LVEF ≤ 40% based on last local measurement using echocardiography, multigated acquisition scan, computed tomography (CT) scanning, magnetic resonance imaging, or ventricular angiography
* Planned discharge to home or other supported care facility where patients are individually responsible for medication management
Exclusion Criteria
* Chronic kidney disease requiring dialysis
* Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
* Unable to participate in longitudinal follow-up, such as plans to move outside the US in the following year
18 Years
ALL
No
Sponsors
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Duke Clinical Research Institute
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Adam DeVore, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, United States
Arkansas Heart Hospital and Clinics
Little Rock, Arkansas, United States
San Gorgonio Memorial Hospital
Banning, California, United States
Memorial Medical Center
Modesto, California, United States
Dignity Health Sequoia Hospital
Redwood City, California, United States
Riverside Community Hospital
Riverside, California, United States
Sutter Medical Center
Sacramento, California, United States
Stanford University
Stanford, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
UC Health Memorial
Colorado Springs, Colorado, United States
Northern Colorado Medical Center
Greeley, Colorado, United States
Stamford Hospital
Stamford, Connecticut, United States
JFK Medical Center
Atlantis, Florida, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Blake Medical Center
Bradenton, Florida, United States
Broward Health Imperial Point
Fort Lauderdale, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Orlando Health
Orlando, Florida, United States
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States
Baptist Hospital
Pensacola, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
South Miami Hospital
South Miami, Florida, United States
Bayfront Health - St. Petersburg
St. Petersburg, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
Florida Hospital Tampa
Tampa, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Winter Haven Hospital
Winter Haven, Florida, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
AU Medical Center
Augusta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Medical Center, Navicent Health (THE)
Macon, Georgia, United States
The Queens Medical Center
Honolulu, Hawaii, United States
Copley Memorial Hospital
Aurora, Illinois, United States
Presence Mercy Medical Center
Aurora, Illinois, United States
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States
Specialty Physicians of Illinois
Olympia Fields, Illinois, United States
Saint Anthony Medical Center
Rockford, Illinois, United States
St Johns Hospital
Springfield, Illinois, United States
The Carle Foundation Hospital
Urbana, Illinois, United States
Indiana University Health Bloomington
Bloomington, Indiana, United States
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, United States
Reid Health
Richmond, Indiana, United States
Genesis Medical Center-Davenport
Davenport, Iowa, United States
King's Daughters Medical Center
Ashland, Kentucky, United States
KentuckyOne Health - Saint Joseph Hospital
Lexington, Kentucky, United States
Norton Women and Children's Hospital
Louisville, Kentucky, United States
Norton Brownsboro Hospital
Louisville, Kentucky, United States
Baptist Health Madisonville
Madisonville, Kentucky, United States
Rapides Regional Medical Center
Alexandria, Louisiana, United States
Natchitoches Regional Medical Center
Natchitoches, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Louisiana State University-Health Science Center- Shreveport
Shreveport, Louisiana, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
MedStar Southern Maryland Hospital Center
Clinton, Maryland, United States
Johns Hopkins University
Columbia, Maryland, United States
Adventist HealthCare Shady Grove
Rockville, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cape Code Hospital
Hyannis, Massachusetts, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
McLaren Greater Lansing
Lansing, Michigan, United States
St. John Macomb-Oakland
Madison Heights, Michigan, United States
MidMichigan Medical Center Midland
Midland, Michigan, United States
McLaren Macomb
Mount Clemens, Michigan, United States
McLaren - Northern Michigan
Petoskey, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
St Lukes Hospital
Duluth, Minnesota, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States
St. Mary's Medical Center
Blue Springs, Missouri, United States
St. Joseph Medical Center
Kansas City, Missouri, United States
North Kansas City Hospital
North Kansas City, Missouri, United States
Cox Medical Centers
Springfield, Missouri, United States
Billings Clinic Hospital
Billings, Montana, United States
Glacier View Research Institute-Cardiology
Kalispell, Montana, United States
Bryan Medical Center
Lincoln, Nebraska, United States
University Medical Center
Las Vegas, Nevada, United States
Southern NH Medical Center
Nashua, New Hampshire, United States
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Saint Michael's Medical Center
Newark, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Albany Medical Center Hospital
Albany, New York, United States
St. Peter's Hospital
Albany, New York, United States
Huntington Hospital
Huntington, New York, United States
United Health Services Hospitals
Johnson City, New York, United States
Mount Sinai Beth Israel
New York, New York, United States
Ellis Hospital
Schenectady, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Richmond University Medical Center
Staten Island, New York, United States
University Hospital (Stony Brook)
Stony Brook, New York, United States
St. Joseph's Hospital
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Charlotte-Mecklenburg Hospital Authority
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Duke Cardiology of Lumberton
Lumberton, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
WakeMed
Raleigh, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Altru Health System
Grand Forks, North Dakota, United States
Summa Health
Akron, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
University Hospitals - Elyria Medical Center
Elyria, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Oklahoma University Health Science Center
Oklahoma City, Oklahoma, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
OHSU Hospital and Clinics
Portland, Oregon, United States
Memorial Medical Center
Johnstown, Pennsylvania, United States
WellSpan Good Samaritan Hospital
Lebanon, Pennsylvania, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Plaza Medical Center of Fort Worth
Fort Worth, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Christus Good Shepherd Medical Center
Longview, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Guadalupe Regional Medical Center
Seguin, Texas, United States
University of Texas Health Science Center at Tyler
Tyler, Texas, United States
Inova Alexandria Hospital
Alexandria, Virginia, United States
Riverside Regional Medical Center
Newport News, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
CJW Medical Center
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Wheeling Hospital
Wheeling, West Virginia, United States
Mayo Clinic Health System Franciscan Medical Center
La Crosse, Wisconsin, United States
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States
Ascension-All Saints
Racine, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Countries
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References
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Rao VN, Kaltenbach LA, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Butler J, Allen LA, Lanfear DE, Ariely D, Miller JM, Brodsky MA, Lalonde TA, Lafferty JC, Granger CB, Hernandez AF, Devore AD; Durham, North Carolina; Los Angeles, California; Cleveland, Ohio; Jackson, Misssissippi, Aurora, Colorado; Detroit, Michigan; Ewa Beach, Hawaii; Staten Island, New York. The Association of Digital Health Application Use With Heart Failure Care and Outcomes: Insights From CONNECT-HF. J Card Fail. 2022 Oct;28(10):1487-1496. doi: 10.1016/j.cardfail.2022.07.050. Epub 2022 Jul 26.
DeVore AD, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Lewis EF, Butler J, Pina IL, Allen LA, Yancy CW, Cooper LB, Felker GM, Kaltenbach LA, McRae AT, Lanfear DE, Harrison RW, Disch M, Ariely D, Miller JM, Granger CB, Hernandez AF. Effect of a Hospital and Postdischarge Quality Improvement Intervention on Clinical Outcomes and Quality of Care for Patients With Heart Failure With Reduced Ejection Fraction: The CONNECT-HF Randomized Clinical Trial. JAMA. 2021 Jul 27;326(4):314-323. doi: 10.1001/jama.2021.8844.
DeVore AD, Granger BB, Fonarow GC, Al-Khalidi HR, Albert NM, Lewis EF, Butler J, Pina IL, Heidenreich PA, Allen LA, Yancy CW, Cooper LB, Felker GM, Kaltenbach LA, McRae AT, Lanfear DE, Harrison RW, Kociol RD, Disch M, Ariely D, Miller JM, Granger CB, Hernandez AF. Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure: Rationale and design of CONNECT-HF. Am Heart J. 2020 Feb;220:41-50. doi: 10.1016/j.ahj.2019.09.012. Epub 2019 Oct 23.
Other Identifiers
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Pro00074513
Identifier Type: -
Identifier Source: org_study_id
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