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

Duke University

Status: Completed

Conditions: Congestive Heart Failure

Treatments: Behavioral: Williams LifeSkills

Study type: Interventional

Funder types: Other

Identifiers

NCT03043261

Pro00078272

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Psycho-Behavioral Intervention

Experimental group

Description:

Williams LifeSkills modules which cover 10 core skills designed to improve coping skills, stress management and interpersonal relationships: 1) being aware of negative thoughts and feelings, 2) making a decision, 3) deflection skills, 4) problem solving or action skills, 5) assertion, 6) saying "no", in addition to the following preventive skills: 7) speaking up, 8) listening, 9) empathy and 10) increasing positives

Treatment:

Behavioral: Williams LifeSkills