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

Primary Purpose

Congestive Heart Failure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Williams LifeSkills

About this trial

This is an interventional other trial for Congestive Heart Failure focused on measuring CHF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pamela Bonner

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psycho-Behavioral Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Subject retention

Percentage of subjects who complete the intervention

Secondary Outcome Measures

Full Information

NCT ID

NCT03043261

First Posted

February 2, 2017

Last Updated

May 4, 2018

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03043261

Brief Title

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

Acronym

EMERGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

January 29, 2018 (Actual)

Primary Completion Date

April 7, 2018 (Actual)

Study Completion Date

April 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congestive Heart Failure

Keywords

CHF

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Psycho-Behavioral Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Williams LifeSkills

Intervention Description

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

Primary Outcome Measure Information:

Title

Subject retention

Description

Percentage of subjects who complete the intervention

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Jiang, M.D.

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pamela Bonner

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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