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Integrated Disease Management for Heart Failure
N/A
Waitlist Available
Led By Christopher Licskai
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HF or cardiovascular related hospitalization and/or ED visit in the 24 months prior to recruitment
Clinical diagnosis of HF and a supporting diagnostic echocardiogram
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare an integrated disease management program for heart failure patients receiving treatment at a primary care facility to usual care. The primary outcome is a reduction in the total number of all-cause hospitalizations and ED visits.
Who is the study for?
This trial is for heart failure patients who've had a related hospital visit in the last 2 years, can understand English, and are stable enough to complete surveys. They should be classified as stage II-IV by NYHA standards and not enrolled in other cardiac studies or have severe kidney issues requiring dialysis.Check my eligibility
What is being tested?
The study tests an integrated disease management program for heart failure at primary care facilities, including patient education and self-care skills training. It compares usual care with this new approach on hospital visits, emergency department trips, quality of life, and mortality.See study design
What are the potential side effects?
Since the intervention involves education and self-management training rather than medication or invasive procedures, typical medical side effects are not expected. However, participants may experience stress or discomfort from changing their lifestyle or managing their condition differently.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been hospitalized or visited the ED for heart failure or heart issues in the last 2 years.
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I have been diagnosed with heart failure and had an echocardiogram.
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My heart condition is moderately to very limiting.
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My heart's pumping ability is either normal or below 45%.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite of all cause mortality, hospital admissions and emergency department visits
Secondary outcome measures
Acute Heart Failure Episodes
Atlanta Heart Failure Knowledge Questionnaire
Health Service Use - Emergency Department visit
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Integrated Disease ManagementExperimental Treatment1 Intervention
Physicians randomized to intervention will attend a training session on the program standards and details of the IDM. Following the initial baseline interview a heart failure educator (HFE) will meet with subjects to obtain a detailed history of their HF, provide education, self-care management strategies (medication adherence, symptoms monitoring, dietary adherence, fluid restriction, exercise, weight management, smoking cessation) and review immunization status. A self-management action plan will be developed with the study physician and HFE to enable monitoring and management of HF by the participant.
Group II: Usual CareActive Control1 Intervention
Subjects will receive HF care as usually provided by their physician as advised or as needed. Study commitments for the control group include the initial interview, the expected time allotment for this initial visit is 1 hour. Telephone follow-up will occur at 3 months and 9 months to collect exacerbation data and maintain contact with participant. At 6 months and 12 months telephone follow-up will be conducted by the research assistant and the questionnaires will be completed.
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Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
656 Previous Clinical Trials
413,203 Total Patients Enrolled
7 Trials studying Heart Failure
1,607 Patients Enrolled for Heart Failure
Christopher LicskaiPrincipal InvestigatorLawson
2 Previous Clinical Trials
526 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been hospitalized or visited the ED for heart failure or heart issues in the last 2 years.You are currently participating in another study related to heart health.I have received heart failure education via a program like Telehomecare in the last 6 months.I have been diagnosed with heart failure and had an echocardiogram.You have a terminal illness and are not expected to live for more than a year.My blood pressure and heart rate are stable.I am scheduled for heart rehab.I have trouble thinking or remembering which makes it hard for me to fill out forms.My heart condition is moderately to very limiting.My heart's pumping ability is either normal or below 45%.I am waiting for heart surgery.I am on dialysis due to severe kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Integrated Disease Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for participants in this research?
"Affirmative. According to information held on clinicaltrials.gov, this study is actively recruiting participants and was initially posted on May 25th 2021; the data has been recently updated as of March 23rd 2022. The trial will be enrolling 280 patients at one site in total."
Answered by AI
What are the overarching goals of this research project?
"This 12-month clinical trial is intended to evaluate the Composite of Heart failure (HF) related hospitalization and Emergency Department visits. Furthermore, secondary objectives consist of assessing Health Service Use -unscheduled physician visits, New york Heart Association (NYHA), and Atlanta Heart Failure Knowledge Questionnaire (AHFKQ)."
Answered by AI
How many participants are being admitted into this experiment?
"Affirmative. According to clinicaltrials.gov, this medical experiment is currently open for recruitment and was first listed on May 25th 2021. The most recent update occurred on March 23rd 2022 , with a goal of recruiting 280 patients at 1 site."
Answered by AI
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