Universidade Federal do Rio Grande do Sul - Post Graduated Program
Porto Alegre, Rio Grande do Sul, 90035003, Brazil
NCT Number: NCT01213875
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Porto Alegre, Rio Grande do Sul, 90035003, Brazil
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Education on Heart Failure, Home Intervention
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.
Time frame: up to 36 months
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.
Time frame: 36 months
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).
Hospital de Clinicas de Porto Alegre
Other
Acronym: HELEN II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03446651
Cardiovascular Diseases, Heart Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT05806606
Behavior, Cardiovascular Diseases
Hong Kong
View Trial DetailsNCT06847438
Cardiovascular Diseases, Heart Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT07721909
Cardiovascular Diseases, Heart Diseases
Muscat, Oman
View Trial Details