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NCT Number: NCT04637776

Psychosocial Syndemics of Heart Failure

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnes-Jewish Hospital at Washington University Medical Center

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Hospitalization

Other

Hospitalization for any reason

Primary outcomes

  1. Hospital readmissions

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

    Number of hospital readmissions for HF or for other reasons

Secondary outcomes

  1. HF Self-Care

    Time frame: Baseline

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

  2. Global health

    Time frame: Baseline

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

  3. Medication management

    Time frame: Baseline

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

  4. Activities of daily living

    Time frame: Baseline

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

  5. Perceived stress

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2020
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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