Nursing Teleconsultation for Patients With Heart Failure

Heart Failure Clinical Trial

— NurTHF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05027399
• Other study ID #: Monitoring by teleconsultation
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: November 22, 2022

Study information

• Verified date: July 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 22, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Nursing teleconsultation for lifestyle changes
Guidance on better medication adherence, monitoring of signs and symptoms of exacerbation of heart failure, guidance on the need for fluid restriction.

Locations

Country	Name	City	State
Brazil	Heart Institute (InCor), Hospital das Clinicas do HCFMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Fang JC, Ewald GA, Allen LA, Butler J, Westlake Canary CA, Colvin-Adams M, Dickinson MG, Levy P, Stough WG, Sweitzer NK, Teerlink JR, Whellan DJ, Albert NM, Krishnamani R, Rich MW, Walsh MN, Bonnell MR, Carson PE, Chan MC, Dries DL, Hernandez AF, Hershberger RE, Katz SD, Moore S, Rodgers JE, Rogers JG, Vest AR, Givertz MM; Heart Failure Society of America Guidelines Committee. Advanced (stage D) heart failure: a statement from the Heart Failure Society of America Guidelines Committee. J Card Fail. 2015 Jun;21(6):519-34. doi: 10.1016/j.cardfail.2015.04.013. Epub 2015 May 4. — View Citation

Gomes BR, Bocchi EA. Quality of Life in Heart Failure: An Important Goal in Treatment. Arq Bras Cardiol. 2020 Jan;114(1):33-34. doi: 10.36660/abc.20190741. English, Portuguese. — View Citation

Rutledge CM, Kott K, Schweickert PA, Poston R, Fowler C, Haney TS. Telehealth and eHealth in nurse practitioner training: current perspectives. Adv Med Educ Pract. 2017 Jun 26;8:399-409. doi: 10.2147/AMEP.S116071. eCollection 2017. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in the quality of life of patients who receive teleconsultations with a nurse	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.	3 months
Primary	Improvement in the therapeutic adhesion of patients who receive teleconsultations with a nurse	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.	3 months