Nursing Teleconsultation for Patients With Heart Failure

NCT ID: NCT05027399

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2022-11-22

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: ACTIVE_COMPARATOR

Nursing teleconsultation for lifestyle changes

Intervention Type: BEHAVIORAL

Guidance on better medication adherence, monitoring of signs and symptoms of exacerbation of heart failure, guidance on the need for fluid restriction.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Heart Institute (InCor), Hospital das Clinicas do HCFMUSP

São Paulo, , Brazil

Countries

Brazil

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 32049167 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25953697 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28721113 (View on PubMed)

Other Identifiers

Monitoring by teleconsultation

Identifier Type: -

Identifier Source: org_study_id