Telenursing in Coronary Artery Disease

NCT07110779 | Not Yet Recruiting DMC

• 1 other identifier: TELENURS_CAD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to determine whether follow-up through telehealth consultations can enhance adherence to medication and increase knowledge about heart disease in patients with coronary artery disease (CAD) who have undergone coronary angioplasty. It can include individuals of any sex or gender, aged over 18, and with access to communication devices such as a cell phone, tablet, or internet-enabled computer. The main questions to be answered are:

• Does follow-up of patients with CAD through telenursing consultations improve adherence to the proposed treatment?
• Does the follow-up of patients with CAD, through telenursing consultations, improve knowledge about heart disease? The researchers will compare these patients with others who will be followed up as usual at the hospital to determine which group shows better adherence to drug treatment and greater knowledge about heart disease. The participants will have telenursing consultations at three intervals: one, three, and five months after the initial consultation. After six months from the first interview, both groups will be assessed. They will also be invited to participate in an activity to share their experiences and identify research priorities in the field, with the option to collaborate on future research.

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Keywords

coronary artery disease; cardiovascular diseases; telenursing; digital health; nursing

Outcome Measures

Primary Outcomes (2)

• CADE-Q SV score

  The knowledge score regarding coronary artery disease (CAD) will be calculated using the Coronary Artery Disease Education Questionnaire Short Version (CADE-Q SV). This consists of 20 questions divided into five categories: clinical condition, risk factors, exercise, nutrition, and psychosocial risk. One point is awarded for each correct answer, with a maximum score of 20 points. The questionnaire aims to identify areas of low knowledge.

  From the first appointment after coronary angioplasty until six months afterwards.

• MTA score

  Adherence to the proposed treatment will be calculated using the Measure of Treatment Adherence (MTA) instrument. This consists of seven questions, with answers obtained using a six-point Likert scale. Adherence to treatment is determined by adding the values of each answer and dividing by the total number of items. Patients with an arithmetic mean score between one and four are considered non-adherent. Those with a score between five and six are considered adherent.

  From the first appointment after coronary angioplasty until six months afterwards.

Secondary Outcomes (11)

• Blood pressure

  At the first consultation after coronary angioplasty, and six months later.

• Heart rate

  At the first consultation after coronary angioplasty, and six months later

• Respiratory rate

  At the first consultation after coronary angioplasty, and six months later

• Temperature

  At the first consultation after coronary angioplasty, and six months later

• Capillary blood glucose

  At the first consultation after coronary angioplasty, and six months later

Study Arms (2)

Telenursing consultation

EXPERIMENTAL

The intervention consists of telenursing appointments held at three points in time: one, three and five months after the first appointment.

Behavioral: Telenursing consultation

Traditional follow-up

NO INTERVENTION

A final face-to-face evaluation will be conducted six months after the angioplasty to assess adherence to treatment and understanding of the coronary artery disease.

Interventions

Telenursing consultation BEHAVIORAL

Telenursing consultations, which will be carried out via telephone calls, video calls, or messaging platforms, will be held between one, three, and five months after the first consultation. The North American Nursing Diagnosis Association (NANDA-I), the Nursing Outcomes Classification (NOC), and the Nursing Interventions Classification (NIC) taxonomies will be used to structure these consultations.

Telenursing consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing coronary angioplasty who have access to communication devices (mobile phone, tablet or computer with internet access).

You may not qualify if:

• Patients with serious comorbidities that prevent remote monitoring, those without access to the necessary technology for remote nursing, and those with a diagnosis that prevents communication.

Sponsors & Collaborators

• Fernanda Maria Alves Lima: lead
• Faculdade de Medicina de Botucatu, UNESP, Botucatu, Brasil: collaborator

Study Sites (1)

Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, 18618687, Brazil

Location

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Related Links

• World Health Organization (WHO). Noncommunicable diseases.
• Risk Factors for Coronary Artery Disease
• Conselho Federal de Enfermagem - COFEN. Código de Ética dos Profissionais de Enfermagem.
• World Health Organization (WHO). Global strategy on digital health 2020-2025.
• Brasil. Ministério da Saúde (MS). Estratégia de Saúde Digital para o Brasil 2020-2028.
• Brasil. Lei n° 14.510, de 27 de dezembro de 2022. Altera a Lei nº 8.080, de 19 de setembro de 1990, para autorizar e disciplinar a prática da telessaúde em todo o território nacional.
• Brasil. Portaria GM/MS n° 635, de 22 de maio de 2023. Institui, define e cria incentivo financeiro federal de implantação, custeio e desempenho para as modalidades de equipes Multiprofissionais na Atenção Primária à Saúde.
• Organização Pan-Americana de Saúde (OPAS). Organização Mundial da Saúde. Teleconsulta durante uma pandemia.
• Conselho Federal de Enfermagem (COFEN). Resolução n° 634/2020. Autoriza e normatiza a teleconsulta de enfermagem como forma de combate à pandemia provocada pelo novo coronavírus (Sars-Cov-2)
• Conselho Federal de Enfermagem (COFEN). Resolução n° 696/2022. Dispõe sobre a atuação da Enfermagem na Saúde Digital, normatizando a Telenfermagem.
• Conselho Federal de Enfermagem (COFEN). Resolução COFEN nº 736/2024. Dispõe sobre a implementação do Processo de Enfermagem em todo contexto socioambiental onde ocorre o cuidado de enfermagem.
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• Conselho Nacional de Saúde (BR). Resolução nº 466, de 12 de dezembro de 2012.

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Fernanda MA Lima, PhD

  Universidade Estadual Paulista "Júlio de Mesquita Filho" - Unesp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda MA Lima, PhD

CONTACT

+55 14 3880-1301; fma.lima@unesp.br

Marla AG Avila, Professor

CONTACT

+55 14 3880-1707; marla.avila@unesp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Collaborating professor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: August 2025 - October 2026
• Access Criteria: Access to research data by external parties will only be authorized upon prior request to the project's managing researcher. Data linked to manuscripts submitted or in the process of being submitted will be shared after acceptance and publication.

Locations

BR (1)