Effectiveness of Nursing Educational Intervention on Vascular Access Self-Care in Hemodialysis
Phase: NA
Conditions: Chronic Kidney Disease Patients on Hemodialysis
Sponsor: Aveiro University

 
 
 
 
 
Doc.-ID:   DIASP-179-5 
 
 
 
 
 
 
 
 
 
 
Effectiveness of Nursing Educational Intervention on Vascular Access Self-Care in 
Hemodialysis 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
NCT ID not yet assigned 
 
 
 
13/06/2024

 
 
 
 
 
Doc.-ID:   DIASP-179-5 
DIAVERUM STUDY PROPOSAL TEMPLATE 
 
A. STUDY CHARACTERISTICS 
 
A1. PRINCIPAL INVESTIGATOR 
First name: Ana Catarina 
Last name: Santos Brito da Silva 
E-mail: catarina.brito@ua.pt 
Phone: +351 910 616 059 
 
A1. ACADEMIC SUPERVISOR 
First name: João Filipe 
Last name: Fernandes Lindo Simões 
E-mail: jflindo@ua.pt 
Phone: +351 963 785 175 
 
A2. INSTITUTION 
Unit: University of Aveiro – School of Health Sciences of Aveiro (ESSUA) 
Address: Campus Universitário de Santiago, Agra do Crasto, Building 30, 3810-193 Aveiro 
Website: https://www.ua.pt/pt/essua 
 
A3. PROPOSAL TITLE 
Effectiveness of Nursing Educational Intervention on Vascular Access Self-Care in 
Hemodialysis 
A4. SUBJECT AREA 
Transition process to self-care with vascular access 
 
A5. STUDY DESIGN 
Prospective, quantitative, cross-sectional study, employing a quasi-experimental 
methodology that involves an initial diagnostic assessment, a subsequent educational 
intervention to promote adherence to self-care, and an evaluation of outcomes after this 
intervention. 
“Quasi-experimental studies fall within a positivist methodology, as they have a quantitative 
nature. The way in which the researcher controls the groups exposed to the study and the 

 
 
 
 
 
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manner in which interventions are carried out lead to expected outcomes, that is, an 
induction of results” (Soares, 2021). 
 
 
B. BRIEF STUDY PROTOCOL SUMMARY 
 
B1. SUMMARY 
Background: Chronic Kidney Disease (CKD) is a condition that causes a slow, progressive, 
and irreversible loss of kidney function (Martins & Moura, 2023). The global incidence of 
this disease has been increasing and is currently a matter of great importance. At an 
advanced stage, renal replacement therapy is required, and Hemodialysis (HD) is the 
treatment of choice. 
The therapeutic regimen of HD patients includes blood pressure control, glycemic control, 
anemia management, fluid and dietary restrictions, pharmacological regimen, vascular 
access care, and renal replacement techniques (Ordem dos Enfermeiros, 2016). 
According to Barros (2020), “patients with CKD have educational needs for effective self-
management of the therapeutic regimen.” Self-management is defined by Shen et al. 
(2019) as the ability of an individual to manage symptoms, treatment, physical and 
psychosocial consequences, and lifestyle changes inherent to living with a chronic 
condition. In chronic disease self-management, “health promotion through encouragement 
of self-care” is considered fundamental, leading “nursing to provide interactive care, 
constructed jointly and empowering” (Rocha et al., 2020). Health literacy and the 
acquisition of knowledge for self-management of the health–disease transition process in 
CKD patients are essential for adherence to the therapeutic regimen and self-care. 
Within active participation in their treatment, care of the Vascular Access (VA) is included. 
For HD treatment, there are three main types of VA: arteriovenous fistulas (AVF), 
arteriovenous grafts (AVG), and central venous catheters (CVC). According to Pinto et al. 
(2022), “the creation and maintenance of a functional vascular access is crucial for effective 
hemodialysis therapy” and “the importance of vascular access in patient care (...) is 
recognized by all health professionals and is a determining factor in the success of care 
and treatment effectiveness” (Ordem dos Enfermeiros, 2016). Arasu et al. (2022) add that 
in selecting the type of access, a “pragmatic and patient-centered approach” is required. 
The AVF is the preferred access for HD, as it has the longest lifespan and lowest 
complication rates (Arasu et al., 2022) and is also associated with lower morbidity and 
mortality in CKD patients (Murea et al., 2019). 

 
 
 
 
 
Doc.-ID:   DIASP-179-5 
The nurse is primarily responsible for VA assessment and physical examination prior to 
treatment and plays a key role in identifying dysfunction. Thus, “the nurse should empower 
patients and guide them to recognize the necessary care for the vascular access, in order 
to facilitate adherence to the new routines imposed by treatment through teaching self-
care” (Rocha et al., 2020). 
Regarding VA care, Rocha et al. (2020) note that such care is not limited to treatment 
sessions but is also constant at home, where the patient “takes an even greater role, 
demonstrating commitment to the treatment through self-care.” Therefore, they must 
perform actions to ensure proper development and maintenance of the AVF. Martins and 
Moura (2023) add that self-care for VA “translates into spontaneous and purposeful 
behaviours by the patient aimed at promoting health and well-being and ensuring proper 
vascular access functioning.” 
Given the complexity of these interventions and the considerable care needs, it is essential 
to develop differentiated care models that incorporate new nursing roles, in addition to 
those specific to HD treatment. In this context, the nurse acts as a promoter of patient self-
management, actively contributing to improving the quality of life of individuals with chronic 
conditions (Ma et al., 2022; Mansoor & Khuwaja, 2020). 
In nursing practice, it becomes necessary to provide care with a positive impact on clinical 
and health/quality-of-life outcomes; to establish personalized care plans based on 
individual needs and vulnerabilities; to provide patients and their caregivers with sufficient 
knowledge about their situation—health literacy; and to empower patients to be as 
autonomous as possible, including promoting self-care with their VA. 
To achieve this, “the nurse should use a systematic approach to assess and identify the 
nursing care needs of the patient. In particular, a careful assessment of their knowledge 
about the disease and treatment process (...) aiming at well-being and meeting their needs. 
The nurse should also identify diagnoses, define, and implement interventions to achieve 
nursing-sensitive outcomes” (Ordem dos Enfermeiros, 2016). 
Considering this, it is essential to evaluate the impact of nursing interventions on promoting 
patient self-care, with one key area of study being the impact of nursing educational 
intervention on self-care adherence. To plan and tailor care appropriately, it is important to 
understand the “starting point,” i.e., to assess the self-care profile regarding VA in a group 
of HD patients, to define, implement, and evaluate the impact of an intervention plan. 
Thus, the objectives of the present study are: 

 
 
 
 
 
Doc.-ID:   DIASP-179-5 
1. To assess the self-care profile regarding VA in a population of CKD outpatients in 
HD units; 
2. To evaluate the impact of nursing educational interventions on the transition process 
to self-care with VA in this population. 
To address these objectives, the following research question was formulated: 
What is the impact of nursing educational intervention on the transition process to self-care 
with vascular access in outpatients undergoing hemodialysis? 
 
METHODS 
 
Study type: Prospective, cross-sectional, quantitative study aimed at evaluating the 
effectiveness of nursing educational intervention on VA self-care. This study follows a 
quasi-experimental methodology, involving an initial diagnostic assessment, a set of health 
education sessions, and a subsequent evaluation of the results of this educational 
intervention. 
Population and sample: The population will consist of individuals with CKD undergoing 
outpatient HD at two HD units in the central region of Portugal. The sample will be non-
probabilistic and selected by convenience, including CKD patients in HD whose VA in use 
is an AVF, from the two aforementioned HD units. 
Inclusion criteria: 
• 
Individuals with CKD in HD; 
• 
Independent in self-care; 
• 
With VA – AVF. 
Exclusion criteria: 
• 
VA via CVC or AVG; 
• 
Cognitive impairment (assessed using the Mini Mental State Examination – MMSE 
– developed by Folstein et al., 1975); 
• 
Lack of fluency in Portuguese. 
Data collection instrument: The study will use a data collection instrument consisting of 
three parts: sociodemographic characterization, clinical characterization of participants, 
and assessment of AVF self-care behaviours. 
The first two parts will include: 
• 
Sociodemographic variables: age (years), sex (male/female), household 
composition (number of members), education level (illiterate, primary, secondary, 

 
 
 
 
 
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higher education), and employment status (employed, unemployed, homemaker). 
Categorical variables will be assessed through closed-ended questions, and age 
will be a continuous variable (years). 
• 
Clinical variables: CKD etiology (diabetes, hypertension, polycystic kidney disease, 
glomerulonephritis, hypoplasia/dysplasia, unknown, or other causes), HD duration 
(years), duration of HD with AVF, AVF location/type (cubitocubital, radiocephalic, 
humerobasilic, humerocephalic, humerohumeral), and previous VA complications 
(thrombosis and infection episodes). Clinical data will be obtained from patient 
medical records. 
Self-care behaviours will be assessed using the Scale for Assessment of Self-Care 
Behaviours with AVF in HD developed by Sousa et al. (2015), consisting of 16 items, 
structured into two dimensions: 
1. Prevention of complications – 10 items assessing behaviours related to preventing 
AV thrombosis and infection; 
2. Management of signs and symptoms – 6 items assessing self-care behaviours 
related to detecting VA complications. 
In its original study, this scale showed good reliability (Cronbach’s alpha: global 0.80; 
prevention subscale 0.72; management subscale 0.80). 
A pilot test will be conducted with 4 patients to assess applicability, clarity, and completion 
time. 
Data collection procedure: Participants will be recruited by designated study liaisons from 
each HD unit, in close collaboration with the principal investigator, according to 
inclusion/exclusion criteria. Eligible patients will be invited to participate and given full study 
information. Those who agree will provide written informed consent. 
First phase: sociodemographic and clinical data collection and administration of the AVF 
self-care scale. Data will be collected by the principal investigator, in person, with manual 
completion of the scale. Duration: ~1 month. 
Intervention phase: Based on the first assessment results, patients with suboptimal 
behaviours will receive a tailored nursing educational intervention—a series of health 
education sessions integrated into HD sessions—each lasting approximately 30 minutes. 
Second phase: Three months later, the scale will be re-administered to all initial 
participants, regardless of the need for intervention. Data collection will again be by the 
principal investigator, in person, with manual completion. Duration: ~1 month. 

 
 
 
 
 
Doc.-ID:   DIASP-179-5 
Each participant will be assigned an alphanumeric code for pairing pre- and post-
intervention data. The code–name key will be accessible only to the principal investigator. 
Nursing educational intervention: A set of individual health education sessions, delivered 
using expository methods and an informational leaflet, focusing on: 
• 
Prevention of thrombosis and infection (recognition of complications during and 
between HD sessions, hemostasis care, limb protection from trauma, avoidance of 
non-HD punctures); 
• 
Correct assessment of signs/symptoms suggestive of AVF complications (AVF 
functionality assessment via thrill palpation, detection of thrombosis by absence of 
thrill, changes in colour/sensation of the limb, limb pain). 
The sessions will be conducted by the principal investigator. 
 
ETHICAL PROCEDURES 
 
This research will comply with applicable ethical principles throughout its course. 
Regarding the principles of beneficence and non-maleficence, it is considered that patients 
undergoing the intervention will experience health gains and therefore the study will “do 
good for the participant” (Nunes, 2020) and will not cause harm. 
The principle of veracity will also be ensured by informing patients about the risks and 
benefits of their participation, as stated in the informed consent provided in advance. 
Confidentiality will be guaranteed by protecting any personal information collected, 
ensuring that such data will only be known to the principal investigator and will be deleted 
upon completion of the research. 
 
Under these principles, participants’ rights will be safeguarded, including: the right to avoid 
harm, the right to full knowledge about the study, the right to self-determination, the right 
to anonymity and confidentiality (Nunes, 2020). 
The study will be approved by the Ethics Committee of Diaverum – Investimentos e 
Serviços, Lda., where it will be conducted. Authorization will also be obtained from the 
clinical directors and nurse managers of the participating units. 
Use of the Scale for Assessment of Self-Care Behaviours with AVF in HD has been 
authorized by its authors. 
All paper documentation will be stored in a restricted-access location accessible only to 
the principal investigator. After data entry into a database and pseudonymization, paper 

 
 
 
 
 
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questionnaires will be destroyed. Digital files will be stored in a password-protected folder 
accessible only to the principal investigator and supervisor. 
All paper and digital files will be destroyed when the study ends. 
 
DATA ANALYSIS 
Data analysis will be organized in two parts: 
Part 1 – Sociodemographic and clinical variables: 
• 
Mean and median for quantitative variables (age); 
• 
Absolute frequencies and percentages for categorical variables. 
Part 2 – Scale results: 
• 
Results presented as percentage of responses, as recommended by the scale’s author. 
Impact assessment: 
 
Inferential statistics will be used to compare VA self-care behaviours between the two data 
collection moments (pre- and post-intervention). 
 
 
 

 
 
 
 
 
Doc.-ID:   DIASP-179-5 
 
 
TIMELINE: 
 
 
Ativities 
04/2024 
05/2024 
06/2024 
07/2024 
08/2024 
09/2024 
10/2024 
11/2024 
12/2024 
01/2025 
02/2025 
03/2025 
04/2025 
05/2025 
Literature Review 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant 
identification 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Collection 
(moment 1) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
preparation 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data Collection 
(moment 2) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Interpretative 
results analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Final report and 
submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Doc.-ID:   DIASP-179-5 
EXPECTED RESULTS 
 
At a higher level of abstraction, the primary expected outcome of this study is an 
improvement in VA self-care capacity among CKD outpatients undergoing HD. 
It is also relevant to reflect on possible health gains for patients and contributions to nursing 
professional development. 
From the analysis of behaviours related to AVF complication prevention and management, 
it is expected that patients will demonstrate knowledge of the necessary self-care 
behaviours to recognize changes in AVF function and to adopt behaviours that prevent 
and/or detect complication signs. 
It is considered essential to implement health education programs promoting VA self-care 
behaviours, as Sousa et al. (2020) observed that patients targeted by structured nursing 
interventions show better general self-care behaviours and improved AVF maintenance 
practices. 
Nursing practice in the follow-up and monitoring of CKD patients on regular HD is extremely 
important. In addition to providing treatment-specific care, the nurse should establish a 
therapeutic relationship with the patient. One of this study’s objectives is to empower 
patients for self-care and promote their involvement in treatment, negotiating and adapting 
strategies, facilitating the transition process, and fostering self-care—always aiming to 
address real patient needs. 
Developing nursing care conceptualization that ensures high-quality standards is essential 
for professional practice, representing another expected result and, ultimately, this 
project’s contribution to nursing practice in CKD patient care. 
 
 
B2. KEY REFERENCES 
 
Arasu, R.; Jegatheesan, D.; Sivakumaran, Y. (2022). Overview of hemodialysis access and 
assessment. The Official Journal of the College of Family Physicians of Canada 68(8), 577-582. 
https://doi.org/10.46747/cfp.6808577  
Barros, J. (2020). Desenvolvimento de uma Aplicação para Smartphone: Autogestão da Doença 
Renal Crónica Terminal. [Dissertação de Mestrado, Faculdade de Medicina da Universidade do 
Porto]. Repositório Aberto da Universidade do Porto. https://hdl.handle.net/10216/131176  

 
 
 
 
 
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Castro, M. (2001). Atualização em diálise: Complicações agudas em hemodiálise. J Bras Nefrol 
23(2), 108–113. https://bjnephrology.org/wp-content/uploads/2019/11/jbn_v23n2a05.pdf  
Internacional Council of Nurses. (2018, março 1). Browser CIPE. https://www.icn.ch/icnp-browser  
Ma, L.; Liu, Y.; Lin, Y.; Liao, C.; Hung, K.; Chen, R.; Lu, K.; Ho, K.; Zheng, C. (2022). Factors 
Influencing Self-Management Behaviours among Hemodialysis Patients. Journal of Personalized 
Medicine, 12(11), 1816. https://doi.org/10.3390/jpm12111816   
Mansoor, K.; Khuwaja, H. (2020). The Effectiveness of a Chronic Disease Self-Management 
Program for Elderly People: a Systematic Review. Elderly Health Journal, 6(1), 51-63. 
https://doi.org/10.18502/ehj.v6i1.3416  
Martins, M.; Moura, S. (2023). Analisar o autocuidado com a fístula arteriovenosa. Revista de 
Enfermagem Referência, 6(2), 1-10. https://doi.org/2707/RVI23.11.29211  
Murea, M.; Geary, R.; Davis, R.; Moossavi, S. (2019). Vascular access for hemodialysis: A 
perpetual challenge. Seminars in Dialysis, 32(6), 527–534. https://doi.org/10.1111/sdi.12828  
Nune, L. (2020). ASPETOS ÉTICOS na investigação de Enfermagem. (1ª edição). IPS, ESS, 
Departamento de Enfermagem. http://hdl.handle.net/10400.26/32782  
Oliveira, S. (2008). Elaboração de um instrumento da assistência de enfermagem na unidade de 
hemodiálise. 
Acta 
Paulista 
de 
Enfermagem 
21(número 
especial), 
169-173. 
https://doi.org/10.1590/S0103-21002008000500006 
ORDEM DOS ENFERMEIROS. (2016). Cuidados à pessoa com Doença Renal Crónica Terminal 
em 
Hemodiálise. 
Ordem 
dos 
Enfermeiros. 
https://www.ordemenfermeiros.pt/media/8883/gobphemodialise_vf_site.pdf 
Pinto, R.; Duarte, F.; Mata, F.; Sousa, C.; Salgueiro, A.; Fernandes, I. (2023). Construção e 
validação de um modelo de decisão para a canulação da fistula arteriovenosa em hemodiálise. 
Revista de Enfermagem Referência, 6(2). https://doi.org/10.12707/RVI22021  
Rocha, G.; Oliveira, A.; Oliveira, F.; Rodrigues, V.; Moura, A.; Sousa, E.; Machado, A. (2020). 
Cuidados com o acesso vascular para hemodiálise: revisão integrativa. Revista Cuidarte 12(3), 
e2090. http://dx.doi.org/10.15649/cuidarte.2090  
Shen, H.; Kleij, R.; Boog, P.; Chang, X.; Chavannes, N. (2019). Electronic Health Self-Management 
Interventions for Patients With Chronic Kidney Disease: Systematic Review of Quantitative and 

 
 
 
 
 
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Qualitative 
Evidence. 
Journal 
of 
Medical 
Internet 
Research, 
21(11), 
e12384. 
https://www.jmir.org/2019/11/e12384/citations  
Sousa, C.; Apóstolo, J.; Figueiredo, M.; Dias, V.; Teles, P.; Martins, M. (2015). Construction and 
validation of a scale of assessment of self-care behaviours with arteriovenous fistula in 
hemodialysis. Hemodialysis International, 19, 306-313. https://doi.org/10.1111/hdi.12249  
Sousa, C.; Paquete, A.; Teles, P.; Pinto, C.; Dias, V.; Ribeiro, O.; Manzini, C.; Nicole, A.; Souza, 
L.; Ozen, N. (2020). Investigating the effect of a structured intervention on the development of self-
care behaviours with arteriovenous fistula in hemodialysis patients. Clinical Nursing Research, 
30(6), 866-874. http://doi.org.10.1177/1054773820974834  
 
 
C. BUDGET 
Not applicable. 
 
D. PARTICIPATING CENTERS 
HD Unit of Águeda and HD Unit of Aveiro (DIAVERUM). 
 
E. DISCLOSURE OF INTEREST 
This research project was developed within the Curricular Unit “Internship in Nursing for 
the Person with Chronic Conditions” (1st year, 2nd semester) of the Master’s Degree in 
Medical-Surgical Nursing (MEMC) – chronic condition area – at the School of Health 
Sciences of Aveiro (ESSUA) during the 2023–2024 academic year, under the supervision 
of Professor João Lindo Simões. 
The research will be conducted in the 3rd semester of the MEMC – chronic condition area 
– and will be disseminated at ESSUA, in the participating centres, and at relevant 
congresses in Medical-Surgical Nursing and Nephrology. Publication in scientific journals 
in the field is also intended. 
 
 
 

 
 
 
 
 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
Effectiveness of Nursing Educational Intervention on Vascular Access Self-Care in 
Hemodialysis 
 
 
Informed Consent Form 
NCT ID not yet assigned 
13/06/2024 

 
 
 
 
 
2 
 
 
Informed Consent Statement for Research Study Participants 
Considering the “Declaration of Helsinki” of the World Medical Association and the 
Oviedo Convention 
Within the scope of the Master’s in Medical-Surgical Nursing (MEMC) at the School of 
Health Sciences of the University of Aveiro (ESSUA), Nurse Ana Catarina Silva, a 
collaborator at the Aveiro and Vouga Dialysis Units of Diaverum – Investimentos e 
Serviços, Lda., under the supervision of Professor João Lindo Simões, is conducting a 
research project entitled “Effectiveness of Nursing Educational Intervention on Vascular 
Access Self-Care in Hemodialysis”, whose objective is to assess the effectiveness of 
nursing educational intervention on vascular access self-care. 
For this study, it is necessary to collect sociodemographic and clinical data from 
participants. The required sociodemographic variables are: age, sex, household 
composition, education level, and employment status. The clinical variables are: etiology 
of kidney disease, duration of hemodialysis (in years), type of fistula, and previous vascular 
access complications. 
You will also be asked to complete the Scale for Assessment of Self-Care Behaviors with 
Arteriovenous Fistula in Hemodialysis developed by Sousa et al. (2015), which consists of 
16 items. 
After analyzing the results of this assessment, you may receive a nursing intervention to 
help improve your vascular access care for hemodialysis. All participants will undergo a 
new evaluation, regardless of the first evaluation’s results, and will again be asked to 
complete the above-mentioned scale. 
Participation is voluntary, and your decision to participate or not will have no effect on the 
care you receive. No risks are anticipated from your participation in this research. 
This study has received a favourable opinion from the DIAVERUM Ethics Committee and 
has been duly authorized by the General Management of DIAVERUM – Portugal. 
For ethical purposes, it will be ensured that: 
• 
All data that could identify you will be shared only with persons directly involved in 
the research; 
• 
No identifying information will be included in any report or publication; 

 
 
 
 
 
3 
 
• 
When the study ends, all questionnaires will be destroyed; 
• 
At the end of the study, you may access the results and the final report if you wish. 
All data will be collected in accordance with the General Data Protection Regulation 
(GDPR), in effect since May 25, 2018, and respecting the privacy policy of DIAVERUM. 
Data will be used exclusively for this study. All documentation will be collected and coded 
so as to make identification impossible. Thus, your confidentiality will be ensured, and no 
personal identifying information will be included. If the results of this study are published, 
your identity and that of your family will always remain confidential. 
You have the right to access, portability, rectification, deletion, restriction, and to withdraw 
consent while the data are still non-anonymized. To do so, you may contact the principal 
investigator using the contact details below. 
If 
you 
require 
any 
further 
clarification, 
you 
may 
contact 
us 
at: 
Phone: 
+351 
910 
616 
059 
E-mail: catarinabsilva1993@gmail.com 
If you agree to participate in this nominal group, and considering the Declaration of Helsinki 
of the World Medical Association and the Oviedo Convention, you declare that you 
understand the explanation provided to you about the research in which you will be 
included. You have had the opportunity to ask any questions you deemed necessary to 
decide to participate and have received satisfactory answers. 
You also acknowledge that, according to the recommendations of the Declaration of 
Helsinki, the information provided to you covered the objectives, methods, anticipated 
benefits, potential risks, and possible discomfort. 
Furthermore, you have been assured that you have the right to refuse or withdraw from the 
study at any time, without any prejudice to you. For this purpose, you should contact the 
principal investigator of this study using the contact information provided above. 
Therefore, you agree to participate in this study. 
Date: _______________________ 
Signature of participant: ___________________________________________ 
Signature of person obtaining informed consent: ______________________ 
 
Best regards, 
Ana Catarina Silva