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Heart FailureNCT04637776

Psychosocial Syndemics of Heart Failure

An observational study of Heart Failure, run by Washington University School of Medicine at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Heart failure (HF) is a common and debilitating chronic disease with a poor prognosis. Many patients with HFhave psychiatric problems such as depression and other medical disorders such as lung or kidney disease.This study will examine the effects that these psychiatric and medical disorders have on HF outcomes. 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?
Hospitalization
How many people
367 participants
Where
1 siteUnited States
Study dates
10 Jan 2021to 31 Dec 2024
Phase
Observational
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

Study population: Patients with heart failure who were discharged from a hospital in the St. Louis, Missouri area within the past month.

Who may be able to join

  • Discharged from an inpatient hospitalization within the past month, AND
  • had a clinical diagnosis of HF at admission to or discharge from the hospital, AND
  • met the European Society of HF diagnostic criteria during the hospital stay.

Who cannot join

  • patient's physician advises against participation in the study, OR
  • patient refuses to participate, OR
  • patient's legally authorized representative refuses to allow patient to participate, OR
  • isolated right HF (cor pulmonale), OR
  • reversible HF due to valve disease with impending surgical correction.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Barnes-Jewish Hospital at Washington University Medical Center

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Psychosocial Syndemics and Multimorbidity in Patients With Heart Failure - R01 HL151431

Heart failure (HF) is a common and debilitating chronic disease with a poor prognosis. Many patients with HFhave psychiatric problems such as depression and other medical disorders such as lung or kidney disease.This study will examine the effects that these psychiatric and medical disorders have on HF outcomes.

Read the detailed description

Approximately 6.2 million Americans have heart failure (HF) and the prevalence is increasing rapidly. HF is a common cause of hospitalization and mortality in older adults, and the cost of hospital care for HF is skyrocketing. One reason why HF is so burdensome and costly is that it is often complicated by cardiovascular and noncardiovascular comorbidities, especially in older patients. Psychiatric and medical disorders that are risk factors for incident HF persist after HF has developed, and additional comorbidities accumulate as patients with HF grow older. Thus, HF is embedded within a larger pattern of multimorbidity. Unfortunately, most trials of HF therapies as well as many other studies of HF have excluded patients with complex psychiatric and medical comorbidities or severe cognitive impairment. This has left large gaps in research on the care of older adults with HF. In addition, research on socioeconomic risk factors and health disparities has not been integrated with research on multimorbidity in HF. Heart failure is only one of multiple challenges facing patients with multimorbidity, stressful socioeconomic circumstances, and psychosocial problems, but the fragmentation of research on HF has left us with little understanding of patients with complex psychosocial problems. The purpose of this study is to identify combinations of comorbidities and health disparities may affect HF outcomes and require different mixtures of medical, psychological, and social services to address. It will encompass both psychiatric and medical comorbidities but will emphasize the role of psychiatric comorbidities. Syndemics theory is a useful framework for studying this type of psychosocial and medical complexity. Syndemics, also known as synergistic epidemics, occur when there are adverse interactions between prevalent disorders that concentrate in populations that are vulnerable due to adverse socioeconomic or environmental conditions. The syndemics framework has yielded important insights into a number of other disorders, but it has not been used to study the complex psychosocial problems of patients with HF. To our knowledge, this will be the first study of the syndemics of psychiatric and medical comorbidities in heart failure. The multimorbidity framework is an alternative approach for investigating the effects of multiple comorbidities on health outcomes. The specific aims of the study are: 1) to determine the coprevalence of major psychiatric and medical comorbidities in patients with HF (n=535); 2) to determine whether coprevalent comorbidities have synergistic effects on all-cause readmission and mortality risks, heart failure self-care, and perceived global health; 3) to identify vulnerable subpopulations of patients with HF who have higher coprevalences of syndemic comorbidities compared to less vulnerable subpopulations; 4) to determine the extent to which syndemic comorbidities explain adverse HF outcomes (readmissions and mortality, poor self-care, and poor perceived health) in vulnerable subgroups of patients with HF; and 5) to determine the effects of multimorbidity on readmissions, mortality risk, self-care, and quality of life.

Conditions
Heart Failure
Being tested
Hospitalization
Medical subject headings
Heart Failure

What participants receive

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

  • HospitalizationOther

    Hospitalization for any reason

Study groups in NCT04637776
Study groupRoleWhat they receive
Patients with Heart FailurePatients with heart failure who were discharged within the past month after hospitalization for any reason.
Receives: Other: Hospitalization

What is being measured

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

  1. Hospital readmissions

    Number of hospital readmissions for HF or for other reasons

    Measured: 4 years or less, depending upon available follow-up time

Secondary outcomes (5)
  1. HF Self-Care

    Self-Care of Heart Failure Index v7.2 questionnaire; score range, 0-100 (higher is better)

    Measured: Baseline

  2. Global health

    PROMIS Global Health V1.2 questionnaire 8-item short form; score range, 0-100 (higher is better)

    Measured: Baseline

  3. Medication management

    PROMIS Manage Medications questionnaire 4-item short form; score range, 0-100 (higher is better)

    Measured: Baseline

  4. Activities of daily living

    PROMIS Manage Daily Activities questionnaire 8-item short form; score range, 0-100 (higher is better)

    Measured: Baseline

  5. Perceived stress

    Perceived Stress Scale (Cohen et al., 1983); score range, 0-40 (higher is worse)

    Measured: Baseline

Timeline

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

  1. First posted20 Nov 2020
  2. Study start10 Jan 2021
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04637776
Sponsor's protocol ID
1R01HL151431
Status last verified
Oct 2024
First submitted
16 Nov 2020
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified study data will be shared on request after the closure of the study.

Publications

  • Freedland KE, Steinmeyer BC, Skala JA, Carney RM, Rich MW. Patient-Reported Social Determinants of Health in Patients With Heart Failure. J Am Heart Assoc. 2025 May 20;14(10):e041458. doi: 10.1161/JAHA.124.041458. Epub 2025 May 13.

    PubMed 40357673

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Washington University School of Medicine at 1 site 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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?

Hospital readmissions (time frame: 4 years or less, depending upon available follow-up time). 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 NCT04637776, which also lists 1 linked publication.

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 28 Oct 2024.

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