Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation

Congestive Heart Failure Clinical Trial

— EMERGE  

Official title:

Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043261
• Other study ID #: Pro00078272
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: April 7, 2018

Study information

• Verified date: May 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility, usability, effectiveness and relevance of an integrated psycho-behavioral intervention on heart failure patients in order to increase support, outreach and general well-being of these patients following hospitalization due to heart failure exacerbation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 7, 2018
• Est. primary completion date: April 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male and female patients, age = 18 hospitalized at Duke inpatient service because of heart failure

• NYHA Class = II

Exclusion Criteria:

• Significant cognitive impairment, indicated as a mini-mental state exam (MMSE) total score of 23 or lower

• Lack of convenient internet access outside of hospital

• Alcohol or other drug dependence/abuse within past 90 days as evaluated by review of medical record and patient interview (SCID)

• Severe physical disability (visual, sensory or motor) that may interfere with study participation (assessment, online interactive learning)

• History or presence of psychoses, bipolar disorder, and/or severe personality disorders as evaluated by review of medical record and patient interview (SCID)

• Life-threatening co-morbidity with the likelihood of 50% mortality in one year

• Active suicidal ideations

• Female patients of childbearing potential

• Treatment with electroconvulsive therapy or transcranial magnetic stimulation within past 90 days

• Uncorrected hypothyroidism or hyperthyroidism

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Behavioral:
• Williams LifeSkills
Online multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships.

Locations

Country	Name	City	State
United States	Pamela Bonner	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject retention	Percentage of subjects who complete the intervention	6 month