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Heart FailureCONNECT-HFNCT03035474

Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure

A study testing Digital Engagement and Direct Engagement in people with Heart Failure, run by Duke University at 154 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Digital Engagement and Direct Engagement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,749 participants
Where
154 sitesUnited States
Study dates
21 Apr 2017to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • 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

Who cannot join

  • Prior heart transplant or current/planned left ventricular assistance device
  • 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

Trial locations and contacts

154 sites in 1 country.

154 sites in 1 country

United States154 sites

  • Summa Health

    Akron, Ohio, 44304

  • Albany Medical Center Hospital

    Albany, New York, 12208

  • St. Peter's Hospital

    Albany, New York, 12208

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

  • Rapides Regional Medical Center

    Alexandria, Louisiana, 71301

  • Inova Alexandria Hospital

    Alexandria, Virginia, 22304

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • King's Daughters Medical Center

    Ashland, Kentucky, 41101

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30606

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • JFK Medical Center

    Atlantis, Florida, 33462

  • AU Medical Center

    Augusta, Georgia, 30912

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Copley Memorial Hospital

    Aurora, Illinois, 60504

  • Presence Mercy Medical Center

    Aurora, Illinois, 60506

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • San Gorgonio Memorial Hospital

    Banning, California, 92220

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Billings Clinic Hospital

    Billings, Montana, 59101

  • University of Alabama Hospital

    Birmingham, Alabama, 35233

  • Indiana University Health Bloomington

    Bloomington, Indiana, 47403

  • St. Mary's Medical Center

    Blue Springs, Missouri, 64014

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Manatee Memorial Hospital

    Bradenton, Florida, 34208

  • Blake Medical Center

    Bradenton, Florida, 34209

  • Our Lady of Lourdes Medical Center

    Camden, New Jersey, 08103

  • Charlotte-Mecklenburg Hospital Authority

    Charlotte, North Carolina, 28203

  • John H. Stroger Jr. Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois, 60612

  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland, 20735

  • UC Health Memorial

    Colorado Springs, Colorado, 80909

  • Johns Hopkins University

    Columbia, Maryland, 21044

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Genesis Medical Center-Davenport

    Davenport, Iowa, 52803

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Wayne State University

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • St Lukes Hospital

    Duluth, Minnesota, 55805

  • Duke University Hospital

    Durham, North Carolina, 27710

  • University Hospitals - Elyria Medical Center

    Elyria, Ohio, 44035

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward Health Imperial Point

    Fort Lauderdale, Florida, 33308

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Sparks Regional Medical Center

    Fort Smith, Arkansas, 72901

  • Plaza Medical Center of Fort Worth

    Fort Worth, Texas, 76104

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Altru Health System

    Grand Forks, North Dakota, 58201

  • Spectrum Health

    Grand Rapids, Michigan, 49503

  • Northern Colorado Medical Center

    Greeley, Colorado, 80631

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Memorial Hospital at Gulfport

    Gulfport, Mississippi, 39502

  • The Queens Medical Center

    Honolulu, Hawaii, 96813

  • Ben Taub General Hospital

    Houston, Texas, 77030

  • Huntington Hospital

    Huntington, New York, 11743

  • Cape Code Hospital

    Hyannis, Massachusetts, 02601

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • United Health Services Hospitals

    Johnson City, New York, 13790

  • Memorial Medical Center

    Johnstown, Pennsylvania, 15905

  • Glacier View Research Institute-Cardiology

    Kalispell, Montana, 59901

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Mayo Clinic Health System Franciscan Medical Center

    La Crosse, Wisconsin, 54601

  • McLaren Greater Lansing

    Lansing, Michigan, 48910

  • University Medical Center

    Las Vegas, Nevada, 89102

  • WellSpan Good Samaritan Hospital

    Lebanon, Pennsylvania, 17042

  • KentuckyOne Health - Saint Joseph Hospital

    Lexington, Kentucky, 40504

  • Bryan Medical Center

    Lincoln, Nebraska, 68506

  • Arkansas Heart Hospital and Clinics

    Little Rock, Arkansas, 72211

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Christus Good Shepherd Medical Center

    Longview, Texas, 75601

  • Norton Women and Children's Hospital

    Louisville, Kentucky, 40205

  • Norton Brownsboro Hospital

    Louisville, Kentucky, 40241

  • Duke Cardiology of Lumberton

    Lumberton, North Carolina, 28358

  • Medical Center, Navicent Health (THE)

    Macon, Georgia, 31201

  • St. John Macomb-Oakland

    Madison Heights, Michigan, 48071

  • Baptist Health Madisonville

    Madisonville, Kentucky, 42431

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • MidMichigan Medical Center Midland

    Midland, Michigan, 48670

  • Ascension Columbia St. Mary's Hospital

    Milwaukee, Wisconsin, 53211

  • Memorial Medical Center

    Modesto, California, 95355

  • McLaren Macomb

    Mount Clemens, Michigan, 48043

  • Indiana University Health Ball Memorial Hospital

    Muncie, Indiana, 47303

  • Southern NH Medical Center

    Nashua, New Hampshire, 03060

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Natchitoches Regional Medical Center

    Natchitoches, Louisiana, 71457

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Mount Sinai Beth Israel

    New York, New York, 10003

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Riverside Regional Medical Center

    Newport News, Virginia, 23601

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Oklahoma University Health Science Center

    Oklahoma City, Oklahoma, 73104

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Specialty Physicians of Illinois

    Olympia Fields, Illinois, 60461

  • Orlando Health

    Orlando, Florida, 32806

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32401

  • Baptist Hospital

    Pensacola, Florida, 32501

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • McLaren - Northern Michigan

    Petoskey, Michigan, 49770

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • OHSU Hospital and Clinics

    Portland, Oregon, 97239

  • Ascension-All Saints

    Racine, Wisconsin, 53405

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • WakeMed

    Raleigh, North Carolina, 27610

  • Dignity Health Sequoia Hospital

    Redwood City, California, 94062

  • Reid Health

    Richmond, Indiana, 47374

  • CJW Medical Center

    Richmond, Virginia, 23235

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Riverside Community Hospital

    Riverside, California, 92501

  • Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Adventist HealthCare Shady Grove

    Rockville, Maryland, 20850

  • Sutter Medical Center

    Sacramento, California, 95816

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Methodist Hospital

    San Antonio, Texas, 78229

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Ellis Hospital

    Schenectady, New York, 12309

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Guadalupe Regional Medical Center

    Seguin, Texas, 78155

  • Louisiana State University-Health Science Center- Shreveport

    Shreveport, Louisiana, 71103

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876

  • South Miami Hospital

    South Miami, Florida, 33143

  • St Johns Hospital

    Springfield, Illinois, 62702

  • Cox Medical Centers

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45504

  • Bayfront Health - St. Petersburg

    St. Petersburg, Florida, 33701

  • Northside Hospital

    St. Petersburg, Florida, 33709

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • Stanford University

    Stanford, California, 94305

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • University Hospital (Stony Brook)

    Stony Brook, New York, 11794

  • St. Joseph's Hospital

    Syracuse, New York, 13203

  • Florida Hospital Tampa

    Tampa, Florida, 33613

  • St. Joseph's Hospital

    Tampa, Florida, 33614

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Torrance Memorial Medical Center

    Torrance, California, 90505

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28402

  • Novant Health Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Winter Haven Hospital

    Winter Haven, Florida, 33881

Other trials in United States

About this study

Official title: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT-HF)

CONNECT-HF is a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics.

Read the detailed description

This trial will be a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics. Outcomes will be assessed following discharge for participants hospitalized with acute HF and reduced left ventricular ejection fraction. All participants in the trial will be consented for follow-up as part of the CONNECT-HF registry on clinical outcomes, medication use, and participant-centered outcomes, including quality-of-life (QOL) assessments will be collected up to 12 months post-discharge at pre-specified intervals (6 weeks and 3, 6, and 12 months).

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
Heart Failure
Being tested
Digital Engagement, Direct Engagement
Keywords
Heart Failure, Quality Improvement
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital EngagementOther

    Patient engagement to improve self-management/medication adherence

  • Direct EngagementOther

    Health system engagement to improve local QI programs

Study groups in NCT03035474
Study groupRoleWhat they receive
Direct & DigitalOtherHealth system engagement to improve local QI programs and patient engagement to improve self-management/medication adherence
Receives: Other: Digital Engagement; Other: Direct Engagement
Direct & RegistryOtherHealth system engagement to improve local QI programs and patient and control
Receives: Other: Direct Engagement
Digital & RegistryOtherPatient engagement to improve self-management/medication adherence and control
Receives: Other: Digital Engagement
RegistryNo interventionControl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time-to-first HF rehospitalization or death during the 12-months post-discharge

    Measured: 12-months after discharge

  2. Improvement in an opportunity-based composite score of adherence to quality metrics for HF.

    The opportunity-based composite score will be created to grade the quality of care provided. The numerator will be the number of times that good care is provided; the denominator will be the number of opportunities available. The score will consist of the following quality metrics assessed at the time of hospital discharge and during outpatient follow-up:

    • Use of evidence-based specific β-blockers at ≥ 50% target dose
    • ACE-I, ARB, or sacubitril/valsartan use at ≥ 50% target dose
    • Aldosterone antagonist use
    • Anticoagulation use in participants with atrial fibrillation
    • In participants with an LVEF ≤ 35%, implantable cardioverter defibrillator placement including cardiac resynchronization therapy placement for participants with sinus rhythm, LBBB, and a QRS ≥ 150 ms
    • Attendance at 1 or more of the following: a multidisciplinary HF disease management program, a cardiac rehabilitation program, or HF group educational classes

    Measured: Baseline to 12 months post discharge

Secondary outcomes (3)

  1. Improvement in an opportunity-based composite score for adherence to HF discharge quality measures

    The opportunity-based composite score will be created to grade the quality of care provided. The numerator will be adherence to medications; the denominator will be the number of opportunities available. The per-opportunity adherence rate will consist of the following quality metrics assessed at the time of hospital discharge:

    • ACE-I, ARB, or sacubitril/valsartan prescription at discharge
    • ß-blocker prescription at discharge
    • Discharge instructions addressing activity level, diet, discharge medications, follow-up appointment, weight monitoring, and how to respond to a change in symptoms
    • LVEF assessment
    • Smoking cessation counseling
    • Medication adherence

    Measured: Baseline through study completion, an average of 3 years

  2. If there is a significant positive effect on at least one of the primary endpoints, then participant-level healthcare expenditures

    Measured: 6 months and 1 year postdischarge

  3. Cumulative number of primary composite events of death and total (first and recurrent) HF hospitalizations

    Measured: Baseline through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2017 (estimated)
  2. Study start21 Apr 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
5,749 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03035474
Sponsor's protocol ID
Pro00074513
Acronym
CONNECT-HF
Status last verified
Dec 2020
First submitted
5 Jan 2017
Last updated
25 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35905867

  • 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.

    PubMed 34313687

  • 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.

    PubMed 31770656

Questions about this trial

What is this clinical trial studying?

A study testing Digital Engagement and Direct Engagement in people with Heart Failure, run by Duke University at 154 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-first HF rehospitalization or death during the 12-months post-discharge (time frame: 12-months after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03035474, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.

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