Click on the questions below to see the answer.
What is a clinical trial?
Clinical trials are research projects that help researchers find new ways to treat or care for patients with a certain medical condition. The outcomes of clinical trials often help change the way care is provided, which is why they are very important for medical progress.
What is the CONNECT-HF trial?
CONNECT-HF is a nationwide clinical trial for people who are leaving the hospital after receiving treatment for heart failure. The goal of the CONNECT-HF trial is to help improve care for people with heart failure, so that they can live healthier lives and have a better chance of staying out of the hospital.
Can anybody take part in the CONNECT-HF trial?
Hospital staff or doctors will ask some patients to take part in the trial. Patients must be asked to join the trial at the hospital, during a hospital stay, and will have to meet certain requirements in order to take part.
Who is running the CONNECT-HF trial?
The trial is being run by Duke Clinical Research Institute (DCRI), a special division of Duke University that focuses on carrying out research to improve patient care.
How long will the trial last?
Participants will take part in the trial for one year after enrolling.
Why is the CONNECT-HF trial important?
The information we get from this trial will help hospitals figure out how to better support patients with heart failure in the future. This could be just as important as research looking at new medicines or treatments for heart failure.
What could the CONNECT-HF trial mean for patients?
As a CONNECT-HF trial participant, patients will help doctors understand what really helps people with heart failure in their daily lives. You will also play an active role in working towards their long-term health goals.
What will happen during the trial?
Participants will be given resources with useful ideas and suggestions for how to manage your heart failure once they have left the hospital. CONNECT-HF participants will receive all the tests and medications that their doctors recommend—this care will not be affected by taking part in the trial. To monitor how you are doing, the research team will contact them by phone about four times over a year. Participants' medical care will continue to be provided by your regular doctor.
Do CONNECT-HF participants have to take special or unapproved medications?
No, this trial is not looking at a new medication, and participants will continue their usual clinical care with their physicians.
What are the benefits of taking part in the CONNECT-HF Trial?
There may not be a direct benefit in taking part in this trial. However, people taking part in the trial will be given tips, ideas, and resources that will help make it easier to manage heart failure. They will also learn more about heart failure, and certain lifestyle changes they can make to help improve their everyday lives.
Another possible benefit for people taking part in this trial is that they will be helping researchers learn more about heart failure so that they improve care, which may help many other people in the future.
What are the risks of taking part in this trial?
Because participants will not have to take a certain medication for this trial, the risks of taking part are low. There is a potential risk of loss of confidentiality of their information, but the trial team will make every effort to ensure this does not happen.
Are there any costs to take part in the trial?
There are no extra costs for taking part in the CONNECT-HF trial. Participants will be responsible for the costs of their regular medical care.
How often will I have follow-up calls?
You will have about four phone calls with the research team during the trial. Calls will be made on or near the following times:
- 6 weeks after leaving the hospital
- 3 months after leaving the hospital
- 6 months after leaving the hospital
- 12 months after leaving the hospital
What will I be asked on the follow-up calls?
These phone calls will help researchers understand how you are doing after you have left the hospital, and will include questions about your health, current medicine use, and whether or not you have been admitted to the hospital again since the last call. It may be helpful to have your pill bottles nearby during the call, to help you report your medicine use.
Who will the calls come from?
Follow-up calls will come from the CONNECT-HF trial team at the Duke Clinical Research Institute (Duke University). The caller ID will appear as “Duke” or a 919 area code.
Who should I contact if I have questions about the trial?
If there are any questions you have about the trial, we will be very happy to help. Contact the Duke Clinical Research Institute’s Call Center at 1-877-846-3640.
Who should I contact if I have lost my participant guide?
You may contact the Duke Clinical Research Institute at 1-877-846-3640.
Should I let my doctors know I am taking part in this trial?
Yes, you should tell any doctors you see that you are taking part in this trial. You can direct them to this website for more information.
What should I do if my contact information changes?
You should contact the Duke Clinical Research Institute at 1-877-846-3640 with any changes in contact information, so that we may communicate with you in the future.
What if I want to stop taking part in the trial?
You may stop taking part in the trial at any time. If you withdraw from the trial, no new data about you will be collected. If you choose not to take part in the trial, it will not affect your access to healthcare. There will not be any penalty for leaving the trial.
Will I be told about the trial results?
Yes. When the entire trial has been completed, the CONNECT-HF team will share the results of the study with the public.