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Digital Health Management for Heart Failure
Study Summary
This trial will test the effects of a digital therapeutics software solution on patients with heart failure. The goal is to see if the software can help reduce hospitalizations and improve management of the disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I haven't had or planned any surgery or needle-based procedures in the last 30 days and won't have any in the next 3 months.I have severe lung problems and need oxygen or am waiting for a lung transplant.This criterion refers to the diagnosis of heart failure.I am currently in the hospital or expect to be within the next 2 weeks.I am under 18 or unable to make my own medical decisions.I have always followed my treatment plans.You have a life expectancy of less than 3 months.I am currently on dialysis or waiting for it.I am experiencing severe depression and do not have a caregiver.You are currently participating in another research study.You have a history of alcohol or drug abuse.You have had a heart transplant or have a mechanical heart.I have severe liver problems or am waiting for a liver transplant.I was recently diagnosed with heart failure or my condition has recently worsened.
- Group 1: For patients not followed in a HFC, control HFC-OUT
- Group 2: For patients followed in a heart failure clinic (HFC), intervention HFC-IN
- Group 3: For patients not followed in a HFC, intervention HFC-OUT
- Group 4: For patients followed in a HFC, control HFC-IN
- 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
Could you explain the core aims of this research project?
"Boehringer Ingelheim, the trial sponsor, has set twelve weeks as their primary measurement period. During this time they will assess care consumption and Quality of Life (QoL) changes with the Kansas City Cardiomyopathy Questionnaire. Additionally, Boehringer's secondary objectives are to track a reduction in New york Heart Association classifications and compare guideline-Directed Medical Therapy optimization across medication classes pre-and post-intervention."
Are participants being accepted into this clinical research project?
"As per the clinicaltrials.gov listing, this trial is actively seeking patients to participate in their research. This study was initially published on June 8th 2022 and recently updated on November 22nd 2022."
How many test subjects are actively involved in the trial?
"Affirmative, according to the clinicaltrials.gov information this trial is actively recruiting participants. This research was initiated on June 8th 2022 and revised November 22nd of that same year. 400 individuals are required for enrollment at one facility."
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