Clinical trial NCT04637776: Psychosocial Syndemics of Heart Failure
Official title: Psychosocial Syndemics and Multimorbidity in Patients With Heart Failure - R01 HL151431
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Failure
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heart failure who were discharged from a hospital in the St. Louis, Missouri area within the past month.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital readmissions
timeFrame: 4 years or less, depending upon available follow-up time
Secondary outcomes:
measure: HF Self-Care
timeFrame: Baseline
measure: Global health
timeFrame: Baseline
measure: Medication management
timeFrame: Baseline
measure: Activities of daily living
timeFrame: Baseline
measure: Perceived stress
timeFrame: Baseline
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital at Washington University Medical Center
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kenneth E Freedland, PhD
role: PRINCIPAL_INVESTIGATOR
References: