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

May 4, 2018 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pamela Bonner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 29, 2018

Primary Completion (ACTUAL)

April 7, 2018

Study Completion (ACTUAL)

April 7, 2018

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (ESTIMATE)

February 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00078272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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