Heart FailureHELEN IINCT01213875
A Multifaceted Nurse-based Strategy Reduces HEart FaiLure Morbidity in PatiENts Admitted for Acute Decompensated Heart Failure in Brazil
A study testing Home based education in people with Heart Failure, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The home based intervention is a multidisciplinary approach that has shown benefit in the follow-up of patients with Heart Failure (HF). It is considered one of the most effective approaches and humanized by education and care for the patient in his environment of routine. 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
- 252 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2009to Dec 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, aged 18 years or above, with a diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%), hospitalized for decompensation of HF
- Who agree to participate in the study by signing the Informed Consent.
Who cannot join
- Patients with communication disabilities and people with degenerative neurological diseases.
- Are also excluded patients who presented acute coronary syndrome (ACS) in the last 6 months before randomization
- Patients with renal, hepatic, pulmonary or systemic disease that may confuse the interpretation of the findings or result in limited life expectancy
- Surgical plan or therapeutic that might influence the follow-up
- Pregnancy, diagnosis of acute heart failure secondary to:
- sepsis
Show all 12Show fewer
- myocarditis
- myocardial infarction
- acute peripartum and other cause
- Have no interest in receiving home visits
- Living at a distance greater than 10 km from the hospital of origin
- Not be able to contact by telephone.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul - Post Graduated Program
Porto Alegre, Rio Grande do Sul, 90035003
About this study
The home based intervention is a multidisciplinary approach that has shown benefit in the follow-up of patients with Heart Failure (HF). It is considered one of the most effective approaches and humanized by education and care for the patient in his environment of routine. In this study the monitoring of HF patients in the home after hospital discharge will include the reinforcement, monitoring and reassessment of previously provided guidance on the disease and self-care, compliance to prescribed medications and especially the early recognition of signs and symptoms of decompensation by patients and their caregivers.
Read the detailed description
The epidemiological picture of cardiovascular disease in which the IC sets itself as the leading cause of readmissions in the National Health System and that has not changed over the years, undertake the management of the limited resources of the public health system. Moreover, the IC contributes to significant loss of quality of life of patients, many in socially productive ages resulting in absenteeism and early retirement. This study aims to evaluate the impact of home monitoring, intercalated with telephone contact by the nursing staff at the HF patients, after hospital discharge in relation to the rate of hospital readmissions, compliance and cost-effectiveness this intervention, compared to conventional monitoring of patients within 6 months without this intervention, as well as building a structure that allows the use computerized forms of assessment in nursing in cardiology by mobile technology, assess the knowledge of the disease and the skills to self-care; assess compliance, assess the quality of life, linking the sociodemographic characteristics and clinical with adherence to treatment and rates of readmission in both groups, and check the cost of home monitoring. For this purpose, a randomized clinical trial was designed in two centers, blinded to outcomes and costs of readmission.
Summary of the study:
The home based intervention is a multidisciplinary approach that has shown benefit in the follow-up of patients with Heart Failure (HF). It is considered one of the most effective approaches and humanized by education and care for the patient in his environment of routine. In this study the monitoring of HF patients in the home after hospital discharge will include the reinforcement, monitoring and reassessment of previously provided guidance on the disease and self-care, compliance to prescribed medications and especially the early recognition of signs and symptoms of decompensation by patients and their caregivers.
Detailed description: The epidemiological picture of cardiovascular disease in which the IC sets itself as the leading cause of readmissions in the National Health System and that has not changed over the years, undertake the management of the limited resources of the public health system. Moreover, the IC contributes to significant loss of quality of life of patients, many in socially productive ages resulting in absenteeism and early retirement. This study aims to evaluate the impact of home monitoring, intercalated with telephone contact by the nursing staff at the HF patients, after hospital discharge in relation to the rate of hospital readmissions, compliance and cost-effectiveness this intervention, compared to conventional monitoring of patients within 6 months without this intervention, as well as building a structure that allows the use computerized forms of assessment in nursing in cardiology by mobile technology, assess the knowledge of the disease and the skills to self-care; assess compliance, assess the quality of life, linking the sociodemographic characteristics and clinical with adherence to treatment and rates of readmission in both groups, and check the cost of home monitoring. For this purpose, a randomized clinical trial was designed in two centers, blinded to outcomes and costs of readmission.
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 they are using. A guide to rest and exercise, sexual activity, vaccines, travel and diet (water and salt restriction) will be provided. The involvement of the family will be encouraged and reinforced at every home visit. 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, motor deficit / paralysis and / or unexplained chest pain. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced.
- Conditions
- Heart Failure
- Being tested
- Home based education
- Keywords
- heart failure, nursing, home based intervention, cost, efficacy
- 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 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 |
|---|---|---|
| Experimental: Intervention and control | Experimental | I: Experimental Routine monitoring by health team in the reference institution, four home visits and four telephone contacts with trained nurses.
II: Control Routine monitoring by health team in the reference institution. Receives: Behavioral: Home based education |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was a composite end-point of a first visit to the emergency department (lasting less than 24 hours), or a first hospital readmission (> 24h) or all-cause death, assessed during the first 6 months of follow-up.
This primary outcomes will be measured at each visit, which will have different intervals, according to the research protocol, with a final evaluation after the last home visit.
Home visits (HV): 7 days after discharge, 15 days after 1st phone call (PC), 30 days after 2nd PC, 30 days after 3rd PC.
Phone calls (PC): 7-10 days after 1st HV, 30 days after 2nd HV, 30 days after 3rd HV, 15 days after 4th HV.
All patients come to Hospital evaluation after the 4th phone call.
Measured: Up to 36 months.
Secondary outcomes (2)
Cost-effectiveness of visits to the emergency department and length of hospitalization.
Costs for intervention group include time of nurses home visit and telephone contacts. The effectiveness will be assessed in life earned years.
Home visits (HV): 7 days after discharge, 15 days after 1st phone call (PC), 30 days after 2nd PC, 30 days after 3rd PC.
Phone calls (PC): 7-10 days after 1st HV, 30 days after 2nd HV, 30 days after 3rd HV, 15 days after 4th HV.
All patients come to Hospital evaluation after the 4th phone call.
Measured: up to 36 months
The secondary outcomes were each individual end-points
All end-points were prospectively evaluated by a researcher that was blinded to group assignment, based on the final 6-months visit and the revision of available electronic records. Whenever it was not available, validation was also based on clinical discharge notes (from emergency departments or hospitals distinct from the institution of origin).
Measured: 36 months
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 completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 252 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, HCPA and UFRGS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213875
- Sponsor's protocol ID
- UFRGS and HCPA 09112
- Acronym
- HELEN II
- Status last verified
- Jan 2014
- First submitted
- 9 Nov 2009
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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
- A Multifaceted Nurse-based Strategy Reduces HEart FaiLure Morbidity in PatiENts Admitted for Acute Decompensated Heart Failure in Brazil
- ClinicalTrials.gov ID
- NCT01213875
- Acronym / sponsor ID
- HELEN II / UFRGS and HCPA 09112
- Conditions
- Heart Failure
- Keywords
- heart failure, nursing, home based intervention, cost, efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 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
- Dec 2013 (actual)
- Study completion
- Dec 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.
The home based intervention is a multidisciplinary approach that has shown benefit in the follow-up of patients with Heart Failure (HF). It is considered one of the most effective approaches and humanized by education and care for the patient in his environment of routine. In this study the monitoring of HF patients in the home after hospital discharge will include the reinforcement, monitoring and reassessment of previously provided guidance on the disease and self-care, compliance to prescribed medications and especially the early recognition of signs and symptoms of decompensation by patients and their caregivers.
Detailed description
The epidemiological picture of cardiovascular disease in which the IC sets itself as the leading cause of readmissions in the National Health System and that has not changed over the years, undertake the management of the limited resources of the public health system. Moreover, the IC contributes to significant loss of quality of life of patients, many in socially productive ages resulting in absenteeism and early retirement. This study aims to evaluate the impact of home monitoring, intercalated with telephone contact by the nursing staff at the HF patients, after hospital discharge in relation to the rate of hospital readmissions, compliance and cost-effectiveness this intervention, compared to conventional monitoring of patients within 6 months without this intervention, as well as building a structure that allows the use computerized forms of assessment in nursing in cardiology by mobile technology, assess the knowledge of the disease and the skills to self-care; assess compliance, assess the quality of life, linking the sociodemographic characteristics and clinical with adherence to treatment and rates of readmission in both groups, and check the cost of home monitoring. For this purpose, a randomized clinical trial was designed in two centers, blinded to outcomes and costs of readmission.
Summary of the study:
The home based intervention is a multidisciplinary approach that has shown benefit in the follow-up of patients with Heart Failure (HF). It is considered one of the most effective approaches and humanized by education and care for the patient in his environment of routine. In this study the monitoring of HF patients in the home after hospital discharge will include the reinforcement, monitoring and reassessment of previously provided guidance on the disease and self-care, compliance to prescribed medications and especially the early recognition of signs and symptoms of decompensation by patients and their caregivers.
Detailed description: The epidemiological picture of cardiovascular disease in which the IC sets itself as the leading cause of readmissions in the National Health System and that has not changed over the years, undertake the management of the limited resources of the public health system. Moreover, the IC contributes to significant loss of quality of life of patients, many in socially productive ages resulting in absenteeism and early retirement. This study aims to evaluate the impact of home monitoring, intercalated with telephone contact by the nursing staff at the HF patients, after hospital discharge in relation to the rate of hospital readmissions, compliance and cost-effectiveness this intervention, compared to conventional monitoring of patients within 6 months without this intervention, as well as building a structure that allows the use computerized forms of assessment in nursing in cardiology by mobile technology, assess the knowledge of the disease and the skills to self-care; assess compliance, assess the quality of life, linking the sociodemographic characteristics and clinical with adherence to treatment and rates of readmission in both groups, and check the cost of home monitoring. For this purpose, a randomized clinical trial was designed in two centers, blinded to outcomes and costs of readmission.
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 they are using. A guide to rest and exercise, sexual activity, vaccines, travel and diet (water and salt restriction) will be provided. The involvement of the family will be encouraged and reinforced at every home visit. 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, motor deficit / paralysis and / or unexplained chest pain. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention and control | Experimental | Behavioral: Home based educationI: Experimental Routine monitoring by health team in the reference institution, four home visits and four telephone contacts with trained nurses. II: Control Routine monitoring by health team in the reference institution. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of both sexes, aged 18 years or above, with a diagnosis of heart failure with systolic dysfunction (ejection fraction ≤ 45%), hospitalized for decompensation of HF
- Who agree to participate in the study by signing the Informed Consent.
Key exclusion criteria (12 listed)
- Patients with communication disabilities and people with degenerative neurological diseases.
- Are also excluded patients who presented acute coronary syndrome (ACS) in the last 6 months before randomization
- Patients with renal, hepatic, pulmonary or systemic disease that may confuse the interpretation of the findings or result in limited life expectancy
- Surgical plan or therapeutic that might influence the follow-up
- Pregnancy, diagnosis of acute heart failure secondary to:
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 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 | Experimental: Intervention and control |
Primary outcome
The primary outcome was a composite end-point of a first visit to the emergency department (lasting less than 24 hours), or a first hospital readmission (> 24h) or all-cause death, assessed during the first 6 months of follow-up.
Time frame: Up to 36 months.
This primary outcomes will be measured at each visit, which will have different intervals, according to the research protocol, with a final evaluation after the last home visit. Home visits (HV): 7 days after discharge, 15 days after 1st phone call (PC), 30 days after 2nd PC, 30 days after 3rd PC. Phone calls (PC): 7-10 days after 1st HV, 30 days after 2nd HV, 30 days after 3rd HV, 15 days after 4th HV. All patients come to Hospital evaluation after the 4th phone call.
2 secondary outcomes
Cost-effectiveness of visits to the emergency department and length of hospitalization.
Time frame: up to 36 months
The secondary outcomes were each individual end-points
Time frame: 36 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 3 Jan 2014.
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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
HCPA and UFRGS
1 site in 1 country: see every site and its status.
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 at 1 site in Brazil.
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 2 inclusion and 12 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.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The primary outcome was a composite end-point of a first visit to the emergency department (lasting less than 24 hours), or a first hospital readmission (> 24h) or all-cause death, assessed during the first 6 months of follow-up. (time frame: Up to 36 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.