An interventional study of Education in Heart Failure, sponsored by Maria Stella Padula. Completed. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by Maria Stella Padula · Not applicable, Interventional, and Prevention
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The study is aimed to evaluate if the education of the caregiver is able to reduce hospital admissions of patients with heart failure assisted at home.
The primary objective of the study is to assess whether an educational intervention aimed at increasing the caregiver's skills is able to reduce hospital admissions for any cause in patients with heart failure assisted at home.
The General Practitioners who agree to participate are randomized in two groups: a) intervention group, whose patients are assisted in accordance with the procedures established by the project; b) control group, whose patients continue to be assisted in the usual modality.
The intervention consists of an educational session for each caregiver aimed at improving his ability to recognize early symptoms and signs of heart failure.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
This study's enrollment of 434 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Maria Stella Padula as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Education of the caregiver
Other: Education
Usual care
Education of the caregiver about early symptoms and signs of heart failure
Hospital admissions for any cause
Hospital admissions for any cause
Time frame: Twelve months
Hospital admissions for cardiovascular causes
Hospital admissions for cardiovascular causes
Time frame: Twelve months
Mortality for general or cardiovascular causes
Mortality for general or cardiovascular causes
Time frame: Twelve months
No study locations are listed for this record.
Plan to share: Yes — all Individual Participant Data that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Ran from Aug 2013 to primary completion in Apr 2016, 32 months.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 32 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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