Heart FailureHFHELENINCT01213862
Home Based Intervention Led by Nurse in Brazil
A study testing Home Based Education in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Home visits (HV) are one of the multidisciplinary approaches that has already shown to benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most effective and humane approaches as it educates and takes care of the patient in his/her routine environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Home Based Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Jan 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes
- Age equal to or above 18 years
- Diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%)
- Hospitalized for heart failure decompensation and who agree to participate in the study by signing a Free Informed Consent Form.
Who cannot join
- Patients presenting with communication barriers and suffering from degenerative neurological diseases.
- Patients who had Acute Coronary Syndrome (ACS) in the past 6 months before randomization
- Patients with renal/hepatic/pulmonary or systemic disease who may confuse the interpretation of findings or result in limited life expectancy
- Surgical or therapeutic treatment that may influence the follow-up
- Pregnancy
- Diagnosis of Heart Failure secondary to:
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- sepsis
- myocarditis
- acute myocardial infarction
- peripartum cardiomyopathy and other acute cause
- No interest in receiving home visits
- Living more than 10 km away for the original hospital
- No possibility of telephone contact.
About this study
Official title: Home Visit Impact on Knowledge of Disease, Self-Care Skills and Quality of Life of Heart Failure Patients: Randomized Clinical Trial
Home visits (HV) are one of the multidisciplinary approaches that has already shown to benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most effective and humane approaches as it educates and takes care of the patient in his/her routine environment. In this study, the follow-up of HF patients in a home setting after being discharged from hospital will include the reinforcement, monitoring and re-evaluation of guidelines previously provided about the disease and self-care, compliance to prescribed medicines and, specially, the early recognition of decompensation signs and symptoms by patients and their caregivers.
Read the detailed description
The epidemiological overview of cardiovascular diseases in which HF turns out to be the main cause of re-hospitalizations in the Unified Health System, which has not changed over the years, impairs the management of the limited resources of the public health system. Additionally, HF leads to substantial damage to the quality of life of patients, many of them at a socially productive age, resulting in early retirements and absences. In this study, the objective is to evaluate the impact of the follow-up of heart failure patients at home, interspersed with telephone contacts, by the nursing team, after hospital discharge, regarding knowledge of the disease, self-care skills and quality of life improvement, compared with the conventional follow-up of patients in a 6-month period without this intervention, as well as to build a mobile-technology computer structure to make the use of cardiology nursing evaluation forms viable; correlate sociodemographic and clinical characteristics with treatment compliance and re-hospitalization rates in both; and ascertain home follow-up costs.
With this purpose, a two-center randomized clinical trial, blinded for the endpoints re-hospitalization and costs, was designed.
- Conditions
- Heart Failure
- Being tested
- Home Based Education
- Keywords
- Home Based education, Knowledge of Disease, Self-Care Skills, Quality of Life, Heart Failure, Randomized Clinical Trial
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Based EducationBehavioural
Also called Education on Heart Failure, Home based intervention
There will provided education about what is heart failure, its causes, how to recognize signs and symptoms, monitoring of weight and blood pressure, the importance of compliance to treatment. Patients will be instructed about the medications; a guide to rest and exercise, sexual activity, vaccines, travel and diet will be provided. The involvement of the family will be encouraged; the contact with the team should be done when: patient observes an increase of 1 or 2 kg of weight in 2-3 days, worsening of dyspnea on effort, edema in legs / abdomen, worsening of cough, persistent vomiting, syncope, sputum with blood, fever, persistent tachycardia. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced.
| Study group | Role | What they receive |
|---|---|---|
| intervention and control | Experimental | * Group I - Intervention: Routine follow-up in a reference health institution with four home visits and four telephone contacts with specialist nurses.
* Group II - Control: Routine follow-up with the health team in the reference institution. Receives: Behavioral: Home Based Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of the disease
This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
Measured: Home visit 7 days after discharge
Self-care skills.
This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
Measured: Home visit 7 days after discharge.
Quality of Life
This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
Measured: Home visit 7 days after discharge
Secondary outcomes (3)
Changes in functional class.
This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
Measured: Home visits (HV) starting 7days after discharge.
Presentation to emergency department
This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
Measured: Home visits starting 7 days after discharge.
Compliance score.
This secundary outcome will be measured at each visit and phone call, which will have different intervals, according to the research protocol.
Measured: Home visits starting 7 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startAug 2009
- Primary completionJan 2013
- Study completionJan 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Principal investigator, Eneida Rejane Rabelo da Silva, Hospital de Clinicas de Porto Alegre
- Investigators
- Eneida R Rabelo da Silva, RN, ScD, Principal investigator, Federal University of Rio Grande do SulEneida R Rabelo da Silva, RN, ScD, Principal investigator, Universidade Federal do Rio do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213862
- Sponsor's protocol ID
- UFRGS and HCPA 09111
- Acronym
- HFHELENI
- Status last verified
- Dec 2013
- First submitted
- 9 Nov 2009
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mussi CM, Ruschel K, de Souza EN, Lopes AN, Trojahn MM, Paraboni CC, Rabelo ER. Home visit improves knowledge, self-care and adhesion in heart failure: Randomized Clinical Trial HELEN-I. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:20-8. doi: 10.1590/s0104-11692013000700004. English, Portuguese.
PubMed 23459887
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Visit Impact on Knowledge of Disease, Self-Care Skills and Quality of Life of Heart Failure Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01213862
- Acronym / sponsor ID
- HFHELENI / UFRGS and HCPA 09111
- Conditions
- Heart Failure
- Keywords
- Home Based education, Knowledge of Disease, Self-Care Skills, Quality of Life, Heart Failure, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- Aug 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Oct 2010 (estimated)
- 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.
Home visits (HV) are one of the multidisciplinary approaches that has already shown to benefit the follow-up of Heart Failure (HF) patients. It is considered to be one of the most effective and humane approaches as it educates and takes care of the patient in his/her routine environment. In this study, the follow-up of HF patients in a home setting after being discharged from hospital will include the reinforcement, monitoring and re-evaluation of guidelines previously provided about the disease and self-care, compliance to prescribed medicines and, specially, the early recognition of decompensation signs and symptoms by patients and their caregivers.
Detailed description
The epidemiological overview of cardiovascular diseases in which HF turns out to be the main cause of re-hospitalizations in the Unified Health System, which has not changed over the years, impairs the management of the limited resources of the public health system. Additionally, HF leads to substantial damage to the quality of life of patients, many of them at a socially productive age, resulting in early retirements and absences. In this study, the objective is to evaluate the impact of the follow-up of heart failure patients at home, interspersed with telephone contacts, by the nursing team, after hospital discharge, regarding knowledge of the disease, self-care skills and quality of life improvement, compared with the conventional follow-up of patients in a 6-month period without this intervention, as well as to build a mobile-technology computer structure to make the use of cardiology nursing evaluation forms viable; correlate sociodemographic and clinical characteristics with treatment compliance and re-hospitalization rates in both; and ascertain home follow-up costs.
With this purpose, a two-center randomized clinical trial, blinded for the endpoints re-hospitalization and costs, was designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention and control | Experimental | Behavioral: Home Based Education* Group I - Intervention: Routine follow-up in a reference health institution with four home visits and four telephone contacts with specialist nurses. * Group II - Control: Routine follow-up with the health team in the reference institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes
- Age equal to or above 18 years
- Diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%)
- Hospitalized for heart failure decompensation and who agree to participate in the study by signing a Free Informed Consent Form.
Key exclusion criteria (13 listed)
- Patients presenting with communication barriers and suffering from degenerative neurological diseases.
- Patients who had Acute Coronary Syndrome (ACS) in the past 6 months before randomization
- Patients with renal/hepatic/pulmonary or systemic disease who may confuse the interpretation of findings or result in limited life expectancy
- Surgical or therapeutic treatment that may influence the follow-up
- Pregnancy
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 |
|---|---|---|
| Home Based EducationAlso: Education on Heart Failure, Home based interventionThere will provided education about what is heart failure, its causes, how to recognize signs and symptoms, monitoring of weight and blood pressure, the importance of compliance to treatment. Patients will be instructed about the medications; a guide to rest and exercise, sexual activity, vaccines, travel and diet will be provided. The involvement of the family will be encouraged; the contact with the team should be done when: patient observes an increase of 1 or 2 kg of weight in 2-3 days, worsening of dyspnea on effort, edema in legs / abdomen, worsening of cough, persistent vomiting, syncope, sputum with blood, fever, persistent tachycardia. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced. | Behavioural | intervention and control |
Primary outcome
Knowledge of the disease
Time frame: Home visit 7 days after discharge
This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
Self-care skills.
Time frame: Home visit 7 days after discharge.
This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
Quality of Life
Time frame: Home visit 7 days after discharge
This primary outcome will be measured at each home visit, which will have different intervals, according to the research protocol.
3 secondary outcomes
Changes in functional class.
Time frame: Home visits (HV) starting 7days after discharge.
Presentation to emergency department
Time frame: Home visits starting 7 days after discharge.
Compliance score.
Time frame: Home visits starting 7 days after discharge.
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 3 Jan 2014.
- Derived from this study: PubMed 23459887Mussi CM, Ruschel K, de Souza EN, Lopes AN, Trojahn MM, Paraboni CC, Rabelo ER. Home visit improves knowledge, self-care and adhesion in heart failure: Randomized Clinical Trial HELEN-I. Rev Lat Am Enfermagem. 2013 Jan-Feb;21 Spec No:20-8. doi: 10.1590/s0104-11692013000700004. English, Portuguese.
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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.
Eneida R Rabelo da Silva, RN, ScD principal investigator
Federal University of Rio Grande do Sul
Eneida R Rabelo da Silva, RN, ScD principal investigator
Universidade Federal do Rio do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Education in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre.
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 13 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 3 Jan 2014. 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?
Knowledge of the disease (time frame: Home visit 7 days after discharge). The study lists 3 primary outcomes in all. 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 NCT01213862, 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 3 Jan 2014.