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Not yet recruiting NCT07110779

Telenursing in Coronary Artery Disease

No phase Interventional Coronary Artery Disease Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telenursing consultation.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Telenursing in Coronary Artery Disease: Randomized Clinical Trial and Patient Collaboration

Overview

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.

Detailed description

In the face of the global digital transformation, the leadership role of nurses is essential for developing digital health skills and implementing innovative strategies. In the context of coronary artery disease (CAD), telenursing has emerged as a crucial care strategy for monitoring patients, managing risk factors, promoting self-care, and enhancing quality of life.

The researchers will examine the prevalence of comorbidities and risk factors for cardiovascular disease (CVD) in the two study groups. They will also compare adherence to the proposed treatment and knowledge about CAD. Finally, they will draw up a protocol for telenursing consultations for patients with CAD undergoing coronary angioplasty. This protocol will be used at the institution.

Interventions

  • Behavioral Telenursing consultation
    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.

Primary outcome measures

  • CADE-Q SV score [Time frame: From the first appointment after coronary angioplasty until six months afterwards.]
  • MTA score [Time frame: From the first appointment after coronary angioplasty until six months afterwards.]
Secondary outcome measures (11)
  • Blood pressure [Time frame: At the first consultation after coronary angioplasty, and six months later.]
  • Heart rate [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Respiratory rate [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Temperature [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Capillary blood glucose [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Weight [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Height [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Body Mass Index [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Waist [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Hip [Time frame: At the first consultation after coronary angioplasty, and six months later]
  • Waist-to-Hip Ratio [Time frame: At the first consultation after coronary angioplasty, and six months later]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Brazil · 1 center
  • Faculdade de Medicina de Botucatu - UNESP — Botucatu

Publications

  • Delgado AB, Lima ML. Contributo para a validação concorrente de uma medida de adesão aos tratamentos. Psicol Saúde Doenças. 2001; 2(2):81-100. Available from: https://scielo.pt/pdf/psd/v2n2/v2n2a06.pdf
  • Ghisi GL, Durieux A, Manfroi WC, Herdy AH, Carvalho Td, Andrade A, Benetti M. Construction and validation of the CADE-Q for patient education in cardiac rehabilitation programs. Arq Bras Cardiol. 2010 Jun;94(6):813-22. doi: 10.1590/s0066-782x2010005000045. Epub 2010 May 7. English, Portuguese. PMID 20464275
  • Nygaard A, Halvorsrud L, Linnerud S, Grov EK, Bergland A. The James Lind Alliance process approach: scoping review. BMJ Open. 2019 Aug 30;9(8):e027473. doi: 10.1136/bmjopen-2018-027473. PMID 31473612
  • Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P; CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017 Jul 4;167(1):40-47. doi: 10.7326/M17-0046. Epub 2017 Jun 20. PMID 28630973
  • Pereira SM, Barreto ML. Estudos de intervenção. In: Filho NA, Barreto ML. Epidemiologia & Saúde: Fundamentos, Métodos, Aplicações. 1ª ed. Rio de Janeiro: Guanabara Koogan; 2012. p. 215-24.
  • Bensenor IM, Goulart AC, Thomas GN, Lip GYH; NIHR Global Health Research Group on Atrial Fibrillation Management. Patient and Public Involvement and Engagement (PPIE): first steps in the process of the engagement in research projects in Brazil. Braz J Med Biol Res. 2022 Jul 25;55:e12369. doi: 10.1590/1414-431X2022e12369. eCollection 2022. PMID 35894383
  • Oliver K, Kothari A, Mays N. The dark side of coproduction: do the costs outweigh the benefits for health research? Health Res Policy Syst. 2019 Mar 28;17(1):33. doi: 10.1186/s12961-019-0432-3. PMID 30922339
  • Brett J, Staniszewska S, Mockford C, Herron-Marx S, Hughes J, Tysall C, Suleman R. A systematic review of the impact of patient and public involvement on service users, researchers and communities. Patient. 2014;7(4):387-95. doi: 10.1007/s40271-014-0065-0. PMID 25034612

Identifiers

NCT: NCT07110779 · TELENURS_CAD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗