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

NCT ID: NCT03043261

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2018-04-07

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Psycho-Behavioral Intervention

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

Group Type: EXPERIMENTAL

Williams LifeSkills

Intervention Type: BEHAVIORAL

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

Interventions

Williams LifeSkills

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Jiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Pamela Bonner

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00078272

Identifier Type: -

Identifier Source: org_study_id