Heart FailureNCT06273085
Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction
A study testing Patient education in people with Heart Failure and Patient Acceptance of Health Care, run by Medstar Health Baltimore at 4 sites in United States.
Trial summary
The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Patient Acceptance of Health Care
- What is being tested?
- Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Feb 2024to Feb 2025
- 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
- Patients diagnosed with Heart Failure reduced Ejection Fraction (EF≤40%)
- Age >18 years
- Able to consent for enrollment.
- Hospitalized at one of the Medstar facilities (Inpatient)
Who cannot join
- Pregnancy
- Patient with stage D heart failure candidates for advanced therapies or on home inotropes or receiving hospice service
- Patients with advanced organ failure (End stage cancer, Advanced dementia, MELD (Model for End-Stage Liver Disease) score > 30, GFR (Glomerular filtration rate) <25) in whom GDMT is Futile
- Patients with Heart failure Collaboratory Score (HFCS) of 9
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
Ahmad Amin, MD, 401-533-0696, ahmad.amin@medstar.net
- Recruiting
Medstar Harbor Hospital
Baltimore, Maryland, 21225
Sumanth Bandaru, MBBS, 646-240-5289, sumanthkumar.bandaru@medstar.net
- Recruiting
Medstar Franklin Medical Center
Baltimore, Maryland, 21237
Anup Agarwal, MD, 505-620-7815, anup.agarwal@medstar.net
- Recruiting
Medstar Good Samaritan Hospital
Baltimore, Maryland, 21239
Sumanth Bandaru, MBBS, 646-240-5289, sumanthkumar.bandaru@medstar.net
About this study
Official title: Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction- A Randomized Controlled Trial
The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital.
Read the detailed description
This is a randomized clinical trial assessing the possible benefit of post-discharge education on the extent of guideline directed medical treatment for heart failure with reduced ejection fraction. Patients that are admitted to medical facilities of the Medstar health, Baltimore will be screened and if consented, they will all get an initial inhouse face to face education, and upon discharge, they will be randomized to the control group and intervention group. The latter will get more educations via phone-call sessions at 1, 3 and 5 months post discharge. The educational sessions will include educating the benefits of GDMT, reviewing the components of GDMT and their possible side effects, performing Medication reconciliation, Inquiries about reasons not getting the medications and encouraging adherence to clinic visits and requesting the treating providers for GDMT optimization. There will be no formal prescription or change of medication during the educational sessions. GDMT use will be assessed in all patients after 6 months according to GDMT score by the Heart Failure Collaboratory.
- Conditions
- Heart Failure, Patient Acceptance of Health Care
- Being tested
- Patient education
- Keywords
- heart failure with reduced ejection fraction, patient education
- Medical subject headings
- Heart Failure, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient educationBehavioural
3 sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Intervention arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. They will get 3 more sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers. Receives: Behavioral: Patient education |
| Control | No intervention | Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in GDMT score
Changes in GDMT score defined by the Heart Failure Collaboratory (Vericiguat and Ivabradine score will not be included in this study)
Measured: 6 months
Secondary outcomes (3)
Heart Failure hospitalization
Proportion of Heart failure hospitalization
Measured: 6 months
cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant
Proportion of cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant
Measured: 6 months
Number of GDMT classes of medications in use
Number of GDMT classes of medications in use
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anup Agarwal, MD, Principal investigator, MedStar Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273085
- Sponsor's protocol ID
- MOD00016877
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06273085
- Acronym / sponsor ID
- MOD00016877
- Conditions
- Heart Failure, Patient Acceptance of Health Care
- Keywords
- heart failure with reduced ejection fraction, patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medstar Health BaltimoreUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 22 Feb 2024 (actual)
- 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.
The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital.
Detailed description
This is a randomized clinical trial assessing the possible benefit of post-discharge education on the extent of guideline directed medical treatment for heart failure with reduced ejection fraction. Patients that are admitted to medical facilities of the Medstar health, Baltimore will be screened and if consented, they will all get an initial inhouse face to face education, and upon discharge, they will be randomized to the control group and intervention group. The latter will get more educations via phone-call sessions at 1, 3 and 5 months post discharge. The educational sessions will include educating the benefits of GDMT, reviewing the components of GDMT and their possible side effects, performing Medication reconciliation, Inquiries about reasons not getting the medications and encouraging adherence to clinic visits and requesting the treating providers for GDMT optimization. There will be no formal prescription or change of medication during the educational sessions. GDMT use will be assessed in all patients after 6 months according to GDMT score by the Heart Failure Collaboratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Patient educationIntervention arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. They will get 3 more sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers. |
| Control | No intervention | –Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with Heart Failure reduced Ejection Fraction (EF≤40%)
- Age >18 years
- Able to consent for enrollment.
- Hospitalized at one of the Medstar facilities (Inpatient)
Key exclusion criteria (4 listed)
- Pregnancy
- Patient with stage D heart failure candidates for advanced therapies or on home inotropes or receiving hospice service
- Patients with advanced organ failure (End stage cancer, Advanced dementia, MELD (Model for End-Stage Liver Disease) score > 30, GFR (Glomerular filtration rate) <25) in whom GDMT is Futile
- Patients with Heart failure Collaboratory Score (HFCS) of 9
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 |
|---|---|---|
| Patient education3 sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers. | Behavioural | Intervention |
Primary outcome
Change in GDMT score
Time frame: 6 months
Changes in GDMT score defined by the Heart Failure Collaboratory (Vericiguat and Ivabradine score will not be included in this study)
3 secondary outcomes
Heart Failure hospitalization
Time frame: 6 months
cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant
Time frame: 6 months
Number of GDMT classes of medications in use
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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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.
Anup Agarwal, MD principal investigator
MedStar Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient education in people with Heart Failure and Patient Acceptance of Health Care, run by Medstar Health Baltimore at 4 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anup Agarwal, MD (5066207815, anup.agarwal@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GDMT score (time frame: 6 months). 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 26 Feb 2024.