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Completed

NCT Number: NCT03043261

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

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamela Bonner

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Williams LifeSkills

Behavioral

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

Primary outcomes

  1. Subject retention

    Time frame: 6 month

    Percentage of subjects who complete the intervention

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: EMERGE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2017
Registry last updated
May 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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