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Coronary Artery DiseaseNCT07110779

Telenursing in Coronary Artery Disease

A study testing Telenursing consultation in people with Coronary Artery Disease and Cardiovascular Diseases, run by Fernanda Maria Alves Lima at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telenursing consultation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteBrazil
Study dates
Aug 2025to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Brazil1 site

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, São Paulo, 18618687

    Fernanda M A Lima, PhD, +55 14 3880-1301, fma.lima@unesp.br

Other trials in Brazil

About this study

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

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.
Read the 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.

Being tested
Telenursing consultation
Keywords
coronary artery disease, cardiovascular diseases, telenursing, digital health, nursing
Medical subject headings
Coronary Artery Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telenursing consultationBehavioural

    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.

Study groups in NCT07110779
Study groupRoleWhat they receive
Telenursing consultationExperimentalThe intervention consists of telenursing appointments held at three points in time: one, three and five months after the first appointment.
Receives: Behavioral: Telenursing consultation
Traditional follow-upNo interventionA 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (11)

  1. Blood pressure

    Blood pressure measured in millimeters of mercury

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

  2. Heart rate

    Heart rate measured in beats per minute

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

  3. Respiratory rate

    Respiratory rate measured in movements per minute

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

  4. Temperature

    Temperature measured in degrees Celsius

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

  5. Capillary blood glucose

    Capillary blood glucose measured in milligrams per deciliter

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

  6. Weight

    Weight measured in kilograms

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

  7. Height

    Height measured in meters

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

  8. Body Mass Index

    Body mass index measured in kilograms per square meter

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

  9. Waist

    Waist circumference measured in centimeters

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

  10. Hip

    Hip circumference measured in centimeters

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

  11. Waist-to-Hip Ratio

    Waist-to-hip ratio calculated by dividing waist measurement by hip measurement

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2025
  2. Study startAug 2025 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07110779
Sponsor's protocol ID
TELENURS_CAD
Status last verified
Jun 2025
First submitted
21 Jul 2025
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be preserved in accordance with the institution's repository policy and will be made available in the open access repository itself and presented at scientific conferences in the field, as well as publications in journals, keeping sensitive data anonymous.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25034612

  • Gibson A, Britten N, Lynch J. Theoretical directions for an emancipatory concept of patient and public involvement. Health (London). 2012 Sep;16(5):531-47. doi: 10.1177/1363459312438563. Epub 2012 Apr 25.

    PubMed 22535648

  • Hughes M, Duffy C. Public involvement in health and social sciences research: A concept analysis. Health Expect. 2018 Dec;21(6):1183-1190. doi: 10.1111/hex.12825. Epub 2018 Aug 29.

    PubMed 30159960

  • Arruda JA, Lemke VG, Mariani Jr. J, Barbosa AHP, Quadros AS, Pedra C et al. Posicionamento da Sociedade Brasileira de Cardiologia e da Sociedade Brasileira de Hemodinâmica e Cardiologia Intervencionista sobre Centro de Treinamento e Certificação Profissional em Hemodinâmica e Cardiologia Intervencionista - 2020. Arq Bras Cardiol. 2020; 114(1):137-93. DOI: https://doi.org/10.36660/abc.2019084

  • O'Donnell MJ, Chin SL, Rangarajan S, Xavier D, Liu L, Zhang H, Rao-Melacini P, Zhang X, Pais P, Agapay S, Lopez-Jaramillo P, Damasceno A, Langhorne P, McQueen MJ, Rosengren A, Dehghan M, Hankey GJ, Dans AL, Elsayed A, Avezum A, Mondo C, Diener HC, Ryglewicz D, Czlonkowska A, Pogosova N, Weimar C, Iqbal R, Diaz R, Yusoff K, Yusufali A, Oguz A, Wang X, Penaherrera E, Lanas F, Ogah OS, Ogunniyi A, Iversen HK, Malaga G, Rumboldt Z, Oveisgharan S, Al Hussain F, Magazi D, Nilanont Y, Ferguson J, Pare G, Yusuf S; INTERSTROKE investigators. Global and regional effects of potentially modifiable risk factors associated with acute stroke in 32 countries (INTERSTROKE): a case-control study. Lancet. 2016 Aug 20;388(10046):761-75. doi: 10.1016/S0140-6736(16)30506-2. Epub 2016 Jul 16.

    PubMed 27431356

  • Lanas F, Avezum A, Bautista LE, Diaz R, Luna M, Islam S, Yusuf S; INTERHEART Investigators in Latin America. Risk factors for acute myocardial infarction in Latin America: the INTERHEART Latin American study. Circulation. 2007 Mar 6;115(9):1067-74. doi: 10.1161/CIRCULATIONAHA.106.633552.

    PubMed 17339564

  • Borba LO, Capistrano FC, Ferreira ACZ, Kalinke LP, Mantovani MF, Maftum MA. Adaptation and validation of the Measuring of Treatment Adherence for mental health. Rev Bras Enferm. 2018;71(suppl 5):2243-2250. doi: 10.1590/0034-7167-2017-0796. English, Portuguese.

    PubMed 30365790

  • Ghisi GLM, Chaves GSS, Loures JB, Bonfim GM, Britto R. Validação da versão brasileira do questionário curto para avaliar conhecimento de pacientes com doenças cardiovasculares (CADE-Q SV). Arq Bras Cardiol. 2018; 111(6): 841-9. DOI: https://doi.org/10.5935/abc.20180169

Questions about this trial

What is this clinical trial studying?

A study testing Telenursing consultation in people with Coronary Artery Disease and Cardiovascular Diseases, run by Fernanda Maria Alves Lima at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fernanda MA Lima, PhD (+55 14 3880-1301, fma.lima@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CADE-Q SV score (time frame: From the first appointment after coronary angioplasty until six months afterwards.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07110779, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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