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

Study Overview
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Brief Summary
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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.

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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Behavioral: Williams LifeSkills


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psycho-Behavioral Intervention<br>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 | Behavioral: Williams LifeSkills<br>* Online multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject retention | Percentage of subjects who complete the intervention | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHF