Psychosocial Syndemics of Heart Failure
Psychosocial Syndemics and Multimorbidity in Patients With Heart Failure - R01 HL151431
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Kenneth E Freedland, PhD
- Phone Number: 314-286-1311
- Email: freedlak@wustl.edu
Study Contact Backup
- Name: Samantha Boettinger, RN
- Phone Number: 314-286-1315
- Email: samantha.boettinger@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital at Washington University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Patients with Heart Failure
Patients with heart failure who were discharged within the past month after hospitalization for any reason.
|
Hospitalization for any reason
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital readmissions
Time Frame: 4 years or less, depending upon available follow-up time
|
Number of hospital readmissions for HF or for other reasons
|
4 years or less, depending upon available follow-up time
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HF Self-Care
Time Frame: Baseline
|
Self-Care of Heart Failure Index v7.2 questionnaire; score range, 0-100 (higher is better)
|
Baseline
|
|
Global health
Time Frame: Baseline
|
PROMIS Global Health V1.2 questionnaire 8-item short form; score range, 0-100 (higher is better)
|
Baseline
|
|
Medication management
Time Frame: Baseline
|
PROMIS Manage Medications questionnaire 4-item short form; score range, 0-100 (higher is better)
|
Baseline
|
|
Activities of daily living
Time Frame: Baseline
|
PROMIS Manage Daily Activities questionnaire 8-item short form; score range, 0-100 (higher is better)
|
Baseline
|
|
Perceived stress
Time Frame: Baseline
|
Perceived Stress Scale (Cohen et al., 1983); score range, 0-40 (higher is worse)
|
Baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Kenneth E Freedland, PhD, Washington University School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1R01HL151431 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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