NCT03389841

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
434

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 4, 2018

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2.7 years

First QC Date

December 27, 2017

Last Update Submit

January 3, 2018

Conditions

Heart Failure

Keywords

home care servicescomorbidityheart failurecaregivershealth educationpatient admission

Outcome Measures

Primary Outcomes (1)

  • Hospital admissions for any cause

    Hospital admissions for any cause

    Twelve months

Secondary Outcomes (2)

  • Hospital admissions for cardiovascular causes

    Twelve months

  • Mortality for general or cardiovascular causes

    Twelve months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Education of the caregiver

Other: Education

No intervention

NO INTERVENTION

Usual care

Interventions

EducationOTHER

Education of the caregiver about early symptoms and signs of heart failure

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30394960DERIVED

MeSH Terms

Conditions

Heart FailureHealth Education

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
local manager of the province of Modena

Study Record Dates

First Submitted

December 27, 2017

First Posted

January 4, 2018

Study Start

August 1, 2013

Primary Completion

April 10, 2016

Study Completion

April 10, 2016

Last Updated

January 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

all Individual Participant Data that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR