Back to resultsHome Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure focused on measuring home care services, comorbidity, heart failure, caregivers, health education, patient admission
Eligibility Criteria
Inclusion Criteria:
- adults of any age and gender in NYHA (New York Heart Association) classes II, III, IV, assisted exclusively at home;
- willingness and ability to sign a written informed consent;
- presence of a person who cared for the patient in a prevalent and regular way;
- willingness of the caregiver to attend a training meeting.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention
No intervention
Arm Description
Education of the caregiver
Usual care
Outcomes
Primary Outcome Measures
Hospital admissions for any cause
Hospital admissions for any cause
Secondary Outcome Measures
Hospital admissions for cardiovascular causes
Hospital admissions for cardiovascular causes
Mortality for general or cardiovascular causes
Mortality for general or cardiovascular causes
Full Information
NCT ID
NCT03389841
First Posted
December 27, 2017
Last Updated
January 3, 2018
Sponsor
Maria Stella Padula
Collaborators
University of Modena and Reggio Emilia, Local Health Authority of Modena
1. Study Identification
Unique Protocol Identification Number
NCT03389841
Brief Title
Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?
Official Title
Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions? A Clinical Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
April 10, 2016 (Actual)
Study Completion Date
April 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Stella Padula
Collaborators
University of Modena and Reggio Emilia, Local Health Authority of Modena
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
home care services, comorbidity, heart failure, caregivers, health education, patient admission
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
434 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Education of the caregiver
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Education of the caregiver about early symptoms and signs of heart failure
Primary Outcome Measure Information:
Title
Hospital admissions for any cause
Description
Hospital admissions for any cause
Time Frame
Twelve months
Secondary Outcome Measure Information:
Title
Hospital admissions for cardiovascular causes
Description
Hospital admissions for cardiovascular causes
Time Frame
Twelve months
Title
Mortality for general or cardiovascular causes
Description
Mortality for general or cardiovascular causes
Time Frame
Twelve months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adults of any age and gender in NYHA (New York Heart Association) classes II, III, IV, assisted exclusively at home;
willingness and ability to sign a written informed consent;
presence of a person who cared for the patient in a prevalent and regular way;
willingness of the caregiver to attend a training meeting.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all Individual Participant Data that underlie results in a publication
Citations:
PubMed Identifier
30394960
Citation
Padula MS, D'Ambrosio GG, Tocci M, D'Amico R, Banchelli F, Angeli L, Scarpa M, Capelli O, Cricelli C, Boriani G. Home care for heart failure: can caregiver education prevent hospital admissions? A randomized trial in primary care. J Cardiovasc Med (Hagerstown). 2019 Jan;20(1):30-38. doi: 10.2459/JCM.0000000000000722.
Results Reference
derived
Learn more about this trial
Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?
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