Psychosocial Syndemics of Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

367 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-10

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psychosocial Patterns and Prognosis in Patients With Heart Failure

NCT00709241

Systolic Heart Failure Diastolic Heart Failure

COMPLETED

Management of Depression and Anxiety in HF

NCT04636944

Heart Failure Depression Anxiety

COMPLETED

Psycho-behavioral Intervention for Depression in Chronic Heart Failure

NCT03233451

Depression

UNKNOWN NA

Improving Care of Patients With Heart Failure

NCT01461681

Depression Pain Dyspnea +1 more

COMPLETED NA

Depression and Self-care in Heart Failure

NCT01028625

Heart Failure Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with Heart Failure

Patients with heart failure who were discharged within the past month after hospitalization for any reason.

Hospitalization

Intervention Type OTHER

Hospitalization for any reason

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hospitalization

Hospitalization for any reason

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No