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Clinical Trials/NCT05027399
NCT05027399
Unknown
Not Applicable

Nursing Teleconsultation for Patients With Heart Failure Due to Hypersensitive, Chagasic or Idiopathic

University of Sao Paulo General Hospital1 site in 1 country60 target enrollmentOctober 20, 2022
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Sao Paulo General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Improvement in the quality of life of patients who receive teleconsultations with a nurse
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2022
End Date
November 22, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Improvement in the quality of life of patients who receive teleconsultations with a nurse

Time Frame: 3 months

To analyze this result, the questionnaire Minnesota Living with Heart Failure Questionnaire (MLHFQ) validated in portuguese language will be used. Zero is the minimum value and 105 maximum value, The lower score, represents a better patient's quality of life.

Improvement in the therapeutic adhesion of patients who receive teleconsultations with a nurse

Time Frame: 3 months

To analyze this result, the questionnaire European Heart Failure Self-Care Behaviour Scale (EHFScBS) validated in portuguese language will be used. 12 is the minimum value and 60 maximum value, The lower score, represents a better self care.

Study Sites (1)

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