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

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Behavioral: Williams LifeSkills

• Registration Number: NCT03043261
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-06
• Study Start: 2018-01-29
• Primary Completion: 2018-04-07
• Study Completion: 2018-04-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service because of heart failure
• NYHA Class ≥ II

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psycho-Behavioral Intervention	Williams LifeSkills	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

Primary Outcome Measures

Name	Time	Method
Subject retention	6 month	Percentage of subjects who complete the intervention

Trial Locations

Locations (1)

Pamela Bonner; 🇺🇸 Durham, North Carolina, United States