Heart FailureNCT03389841
Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions?
A study testing Education in people with Heart Failure, run by Maria Stella Padula.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2013to 10 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions? A Clinical Randomized Trial.
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Education
- Keywords
- home care services, comorbidity, heart failure, caregivers, health education, patient admission
- Medical subject headings
- Heart Failure, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Education of the caregiver about early symptoms and signs of heart failure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Education of the caregiver Receives: Other: Education |
| No intervention | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admissions for any cause
Hospital admissions for any cause
Measured: Twelve months
Secondary outcomes (2)
Hospital admissions for cardiovascular causes
Hospital admissions for cardiovascular causes
Measured: Twelve months
Mortality for general or cardiovascular causes
Mortality for general or cardiovascular causes
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Aug 2013
- Primary completion10 Apr 2016
- Study completion10 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Stella Padula
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Local Health Authority of Modena
- Responsible party
- Sponsor-investigator, Maria Stella Padula, Italian College of General Practitioners
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389841
- Sponsor's protocol ID
- MSP_01
- Status last verified
- Jan 2018
- First submitted
- 27 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all Individual Participant Data that underlie results in a publication
Publications
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.
PubMed 30394960
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Care for the Patient With Heart Failure: Can Caregiver Education Prevent Hospital Admissions? A Clinical Randomized Trial.
- ClinicalTrials.gov ID
- NCT03389841
- Acronym / sponsor ID
- MSP_01
- Conditions
- Heart Failure
- Keywords
- home care services, comorbidity, heart failure, caregivers, health education, patient admission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Maria Stella PadulaUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia, Local Health Authority of Modena
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 10 Apr 2016 (actual)
- Study completion
- 10 Apr 2016 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: EducationEducation of the caregiver |
| No intervention | No intervention | –Usual care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationEducation of the caregiver about early symptoms and signs of heart failure | Other | Intervention |
Primary outcome
Hospital admissions for any cause
Time frame: Twelve months
Hospital admissions for any cause
2 secondary outcomes
Hospital admissions for cardiovascular causes
Time frame: Twelve months
Mortality for general or cardiovascular causes
Time frame: Twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Derived from this study: PubMed 30394960Padula 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.
- Individual participant dataSharing planned: Yes. all Individual Participant Data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Heart Failure, run by Maria Stella Padula.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admissions for any cause (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.