Congestive Heart FailureEMERGENCT03043261
Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation
A study testing Williams LifeSkills in people with Congestive Heart Failure, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Williams LifeSkills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2018to 7 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service because of heart failure
- NYHA Class ≥ II
Who cannot join
- 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
Show all 10Show fewer
- Active suicidal ideations
- Female patients of childbearing potential
- Treatment with electroconvulsive therapy or transcranial magnetic stimulation within past 90 days
- Uncorrected hypothyroidism or hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Williams LifeSkills
- Keywords
- CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Williams LifeSkillsBehavioural
Online multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Williams LifeSkills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject retention
Percentage of subjects who complete the intervention
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start29 Jan 2018
- Primary completion7 Apr 2018
- Study completion7 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Jiang, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043261
- Sponsor's protocol ID
- Pro00078272
- Acronym
- EMERGE
- Status last verified
- May 2018
- First submitted
- 2 Feb 2017
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation
- ClinicalTrials.gov ID
- NCT03043261
- Acronym / sponsor ID
- EMERGE / Pro00078272
- Conditions
- Congestive Heart Failure
- Keywords
- CHF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 7 Apr 2018 (actual)
- Study completion
- 7 Apr 2018 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psycho-Behavioral Intervention | Experimental | Behavioral: Williams LifeSkillsWilliams 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service because of heart failure
- NYHA Class ≥ II
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Williams LifeSkillsOnline multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships. | Behavioural | Psycho-Behavioral Intervention |
Primary outcome
Subject retention
Time frame: 6 month
Percentage of subjects who complete the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Jiang, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Williams LifeSkills in people with Congestive Heart Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject retention (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.