Psychosocial Syndemics of Heart Failure

NCT04637776 | Active Not Recruiting

• 1 other identifier: 1R01HL151431
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Hospital readmissions

  Number of hospital readmissions for HF or for other reasons

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

Secondary Outcomes (5)

• HF Self-Care

  Baseline

• Global health

  Baseline

• Medication management

  Baseline

• Activities of daily living

  Baseline

• Perceived stress

  Baseline

Study Arms (1)

Patients with Heart Failure

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

Other: Hospitalization

Interventions

Hospitalization OTHER

Hospitalization for any reason

Patients with Heart Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes-Jewish Hospital at Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• 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.

  PMID: 40357673 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kenneth E Freedland, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: January 10, 2021
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The dataset is expected to be finalized in mid- to late-2024.
• Access Criteria: Affiliation with a recognized research institution

Locations

US (1)