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

NCT03043261 | Completed

• 1 other identifier: Pro00078272
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Keywords

CHF

Outcome Measures

Primary Outcomes (1)

• Subject retention

  Percentage of subjects who complete the intervention

  6 month

Study Arms (1)

Psycho-Behavioral Intervention

EXPERIMENTAL

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

Interventions

Williams LifeSkills BEHAVIORAL

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

Psycho-Behavioral Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Pamela Bonner

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wei Jiang, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: January 29, 2018
• Primary Completion: April 7, 2018
• Study Completion: April 7, 2018
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)