Nursing Teleconsultation for Patients With Heart Failure (NurTHF)

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Heart Failure

Treatments: Behavioral: Nursing teleconsultation for lifestyle changes

Study type: Interventional

Funder types: Other

Identifiers

NCT05027399

Monitoring by teleconsultation

Details and patient eligibility

About

The incidence and prevalence of heart failure are increasing and represent a large portion of hospitalizations in Brazil, are also associated with high rates of morbidity, mortality and costs for the service of health. Such data, added to the current scenario of the pandemic caused by COVID-19, reveal the need for changes in clinical practice, so that health care is more effective and cost-effective and reaches patients without exposing them to risks. Thus, the application of nursing interventions through of telephone technology, which has strong evidence of effectiveness found in the literature, has become an alternative for the implementation of clinical interventions. Objective: Evaluate the effectiveness of nursing consultations performed remotely in improving quality of life and adherence to therapy of patients with HF due to cardiomyopathy of different etiologies. Method: The study will have as methodological framework the randomized clinical trial, with the recruitment of 60 volunteers with a diagnosis of chagasic HF, Hypertensive or Idiopathic, who are monitored at the outpatient clinic of Clinical Unit of Cardiomyopathies and Aortic Diseases or Clinical Unit of Hypertension, InCor-HCFMUSP, included by drawing lots into two groups. group A (n=30) will be monitored in biweekly nursing consultations by a period of three months added to the outpatient follow-up, and group B (n = 30) will follow the usual outpatient follow-up. Hypothesis: Patients HF carriers who periodically make telephone consultations of nursing have better quality of life and better therapeutic adherence when compared to patients who only have regular follow-up.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients already registered in a database of the Clinical Unit of Cardiomyopathies and Aortic Diseases, InCor - HCFMUSP and Clinical Hypertension Unit - HCFMUSP, in outpatient follow-up for more than a year;
• Stroke Volume < 40% and >25%

Exclusion criteria

• Patientes with Pacemaker, Defibrillators, Implantable and Cardiac Resynchronization Therapy
• Listed in heart transplant queue
• Not having technological devices that allow the teleconsultation to be carried out
• Psychic inability to understand the questionnaires and answer the questions asked by the interviewer

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention Group

Active Comparator group

Description:

Consultations will be carried out via video call, every 15 days for a period of 3 months, with a total of 6 telephone consultations that will have in order to clarify doubts about the CI, the monitoring of possible clinical signs of instability and help in adapting or creating strategies for better adherence to therapy.

Treatment:

Behavioral: Nursing teleconsultation for lifestyle changes

Control Group

No Intervention group

Description:

Will be composed by the participants who will have no intervention and will continue to monitor according to the institution's routine.