INSTRUMENTS FOR STRATIFYING SELF-CARE IN PEOPLE WITH ARTERIAL HYPERTENSION AND DIABETES MELLITUS: DEVELOPMENT AND VALIDATIONABSTRACT
Objective: To develop and validate a computerized instrument for stratifying self-care among individuals with Systemic Arterial Hypertension and/or Diabetes Mellitus.
Methods: A methodological study was conducted following Pasquali’s psychometric framework. The development process comprised five stages: (1) theoretical grounding of the constructs; (2) construction of the first version of two instruments; (3) expert validation using the Content Validity Index (CVI), adopting >0.80 as the minimum acceptable value per item; (4) content and face validation by specialist judges; and (5) pilot testing after adjustments recommended by the experts. The final instrument was structured using a Likert-type scale.
Results: Thirteen expert judges, all nurses, participated in the content validation process. The instrument demonstrated strong content and appearance validity, with S-CVI/Ave values of 0.93 for the hypertension instrument and 0.94 for the diabetes instrument. The final version showed applicability in Primary Health Care consultations, enabling the identification of self-care patterns among individuals with Systemic Arterial Hypertension and/or Diabetes Mellitus.
Conclusion: The instruments achieved high content validity across most evaluation criteria, with aesthetic aspects corrected during the validation process. The study supports the use of these tools for self-care stratification in routine Primary Health Care, contributing to improved assessment and management of individuals with hypertension and diabetes.
DESCRIPTORS:
Hypertension; Diabetes mellitus; Self-care; Health promotion; Psychometrics; Validation study
RESUMO
Objetivo: elaborar um instrumento informatizado para a estratificação do autocuidado de pessoas com Hipertensão Arterial Sistêmica e/ou Diabetes Mellitus.
Método: estudo metodológico para o desenvolvimento e validação de um instrumento para estratificar o autocuidado de pessoas com Hipertensão Arterial Sistêmica e/ou Diabetes Mellitus. O estudo foi desenvolvido em cinco etapas, por meio do modelo metodológico de Pasquali: 1) fundamentação teórica dos instrumentos; 2) construção da primeira versão de dois instrumentos; 3) validação e recrutamento dos especialistas mediante à aplicação do Índice de Validade de Conteúdo, aceitando-se o valor de >0,8 por item; 4) validação de conteúdo e aparência pelos juízes especialistas; 5) teste piloto após a adequação do instrumento pelos juízes. O instrumento para estratificação foi estruturado por meio de uma escala, tipo Likert.
Resultados: a validação de conteúdo do instrumento se deu por meio de 13 juízes especialistas sendo todos enfermeiros. O instrumento elaborado foi validado em seu conteúdo e aparência, apresentando um S-IVC/Avg acima de 0,80 (0,93 para Hipertensão Arterial Sistêmica e 0,94 par Diabetes Mellitus). Os instrumentos na sua versão final apresentam aplicabilidade em todas as consultas na Atenção Primária à Saúde para assim identificar o padrão de autocuidado dos pacientes com Hipertensão Arterial Sistêmica e/ou Diabetes Mellitus.
Conclusão: os instrumentos apresentaram Índice de Validade de Conteúdo na maioria dos critérios de avaliação, com exceção na sua estética, sendo corrigido. A partir deste estudo, pode-se fomentar a estratificação do autocuidado de pessoas com HAS e DM, podendo ser aplicada em todas as consultas conduzidas na Atenção Primária à Saúde.
DESCRITORES:
Hipertensão; Diabetes mellitus; Autocuidado; Promoção da saúde; Psicometria; Estudo de validação
RESUMEN
Objetivo: Desarrollar y validar un instrumento informatizado para la estratificación del autocuidado de personas con Hipertensión Arterial Sistémica y/o Diabetes Mellitus.
Métodos: Se realizó un estudio metodológico basado en el marco psicométrico de Pasquali. El proceso de desarrollo incluyó cinco etapas: (1) fundamentación teórica de los constructos; (2) construcción de la primera versión de dos instrumentos; (3) validación por expertos mediante el Índice de Validez de Contenido (IVC), adoptando >0,80 como valor mínimo aceptable por ítem; (4) validación de contenido y apariencia por jueces especialistas; y (5) prueba piloto después de los ajustes recomendados por los expertos. El instrumento final fue estructurado con una escala tipo Likert.
Resultados: Participaron 13 jueces especialistas, todos enfermeros. El instrumento presentó elevada validez de contenido y apariencia, con valores de S‑CVI/Ave de 0,93 para el instrumento de hipertensión y 0,94 para el de diabetes. La versión final mostró aplicabilidad en las consultas de la Atención Primaria de Salud, permitiendo identificar los patrones de autocuidado de personas con Hipertensión Arterial Sistémica y/o Diabetes Mellitus.
Conclusión: Los instrumentos alcanzaron altos índices de validez de contenido en la mayoría de los criterios evaluados, con excepción de los aspectos estéticos, que fueron corregidos durante el proceso de validación. El estudio respalda el uso de estas herramientas para la estratificación del autocuidado en la práctica rutinaria de la Atención Primaria de Salud, contribuyendo a una mejor evaluación y manejo de personas con hipertensión y diabetes.
DESCRIPTORES:
Hipertensión; Diabetes mellitus; Autocuidado; Promoción de la salud; Psicometría; Estudio de validación
INTRODUCTION
Chronic conditions consist of health situations that require long-term or permanent follow-up and demand continuous, proactive, and integrated responses and actions from the health care system, health professionals, and service users for their effective control1.
It is important to emphasize that chronic conditions are not analogous to chronic noncommunicable diseases (NCDs). Although noncommunicable diseases such as diabetes mellitus (DM), systemic arterial hypertension (SAH), respiratory problems, and musculoskeletal disorders are considered chronic conditions, there are other conditions - such as individual biopsychological risk factors and communicable diseases like HIV/AIDS, tuberculosis, leprosy, and certain viral hepatitis - that are also characterized as chronic due to their long course and the demands they impose on affected individuals, professionals, and health services2-3.
It is estimated that, each year, NCDs are responsible for 41 million deaths worldwide4. In Brazil, 30% of the population over 18 years of age has at least one NCD5, and up to 76% of deaths are consequences of these conditions6. A study conducted in Brazilian capitals identified SAH and DM as the main NCDs affecting the population, with a homogeneous distribution across the national territory7. Additionally, most chronic conditions progress with increasing age and are more prevalent among white individuals, those with low educational levels, and residents of urban areas5.
NCDs have consequences that extend beyond the affected individuals, impacting families and communities and overburdening health systems4,8. The fundamental principle for providing care that meets people’s health needs and supports the management of NCDs involves offering care that promotes timely information, support, and monitoring, fostering treatment adherence, shared responsibility, and self-care, ultimately resulting in improved quality of life9.
Care for chronic conditions must be guided by the individuality and specificity of each person, emphasizing person-centered care, which incorporates the individual as an active participant in their own health-disease process10.
The management of chronic conditions should occur across all points of the Health Care Network (HCN). However, it is important to highlight the central role of Primary Health Care (PHC). PHC is the most accessible service to the community and, in addition to clinical management, encompasses prevention, health promotion, and health education as core components of its work process, given that noncommunicable diseases remain the leading cause of death and disability10.
In this context, an individual’s adherence to self-care helps enable actions that qualify care according to each person’s profile and particularities, promoting individual strategies (person-centered clinical method, individualized therapeutic plan, motivational interviewing) and group strategies (collective understanding, problem-posing approaches, operative groups, therapeutic groups). It also involves the use of educational resources to support and encourage adherence to pharmacological and non-pharmacological control measures, with the aim of guiding, motivating, and educating the individual and their family11.
The World Health Organization (WHO) defines self-care as the ability of individuals, families, and communities to promote health, prevent disease, maintain health, and cope with disability, with or without the support of a health professional4. It refers to a person’s capacity to carry out actions aimed at preserving their health, development, and well-being. In other words, it is an action performed by the individual, in concrete life situations, for themselves or to regulate factors that affect their own development - activities that benefit life, health, and well-being12.
Self-care among individuals with chronic health conditions often requires lifestyle changes that are necessary to minimize complications and improve symptoms, such as maintaining an adequate and healthy diet, engaging in regular physical activity, and using prescribed medications consistently, among other actions12. However, the literature shows that therapeutic adherence for chronic conditions in Brazil is low (45.5%)13.
Several methods for assessing self-care are described in the literature, but many of them do not consider all aspects of the disease. They tend to focus on adherence to pharmacological treatment and fail to account for the importance of the multiprofessional team, the individual’s knowledge about the disease and treatment side effects, as well as the person’s acceptance of their health condition14-17.
Supported self-care is an approach that promotes individuals’ empowerment by providing information and guidance so they can manage their health and quality of life independently. Supported self-care involves patients in the management of their own condition, engaging them in discussions about diagnosis and treatment options, and jointly developing a self-care plan guided by self-care stratification18. This process includes assessing health status, developing care plans, and continuous monitoring, using resources from health organizations and the community to provide this support19.
This study aims to develop an instrument for the stratification of self-care among individuals with hypertension and diabetes mellitus. To this end, the following question was posed: How will the construction and validation of computerized instruments for self-care stratification assist health professionals in managing individuals with hypertension and diabetes mellitus? Thus, the objective was to develop a computerized instrument for stratifying the self-care of people with hypertension and/or diabetes mellitus.
METHOD
Setting and study participants
The study involved the participation of healthcare professionals working in PHC in the municipalities belonging to the 15th Health Region of Paraná (RSPR), located in the north-central area of the state. The 15th RSPR is composed of 31 municipalities and has approximately 850,000 inhabitants20. During the preparation of this research, the authors did not use Artificial Intelligence tools.
The professionals - nurses - working in PHC within the 15th RSPR served as evaluators (judges) of the instrument developed. Only nurses were selected as evaluators, since the initial care in PHC is provided by these professionals. After this initial assessment, based on the identified needs, patients are referred to other professionals.
The eligibility criteria adopted were inclusion - being a nurse, working in PHC for at least one year, or having at least one year of experience in PHC; exclusion - individuals who were on vacation and/or on leave at the time of data collection.
Study proctocol
This is a methodological study aimed at developing and validating an instrument to stratify self-care among individuals with hypertension (HTN) and/or diabetes mellitus (DM). The study was conducted in five stages, following Pasquali’s (2010)21 methodological model, which is divided into three major poles: theoretical procedures (1 - theory and 2 - construction of the instrument items), empirical procedures (3 - validation process), and analytical procedures (4 - instrument validation and 5 - standardization)21.
In the theoretical procedure, the construction and validation followed this sequence: (1) Theory: the theoretical foundation of the instruments was based on the care guidelines for HTN and DM from the State of Paraná and the Ministério da Saúde (Brazilian Ministry of Health)11,22. For presentation and organization, the study used as a reference the instrument developed and validated - translated and adapted into Portuguese - the Summary of Diabetes Self-Care Activities by Toobert, Hampson, and Glasgow (2000)23, adapted by Bastos, Severo, and Lopes (2007)24, as well as the instrument validated by Mendonça and collaborators (2016)25.
In the second stage, the first version of two instruments was developed: one addressing self-care among individuals with DM and another for those with HTN. A total of 25 specific questions were created for the stratification of self-care in individuals with DM, divided into three major constructs: I - Identification of the individual self-care profile (five questions); II - Stratification of individual self-care (10 questions); III - Individual clinical, biochemical, and anthropometric profile over the past six to twelve months (10 questions). Additionally, 23 questions were developed for the stratification of self-care in individuals with HTN, organized within the same constructs mentioned above, divided as follows: I - (six questions); II - (nine questions); III - (eight questions).
The instrument was created using Microsoft Word®.
The responses followed a Likert-type scale: 1 - None; 2 - One to two; 3 - Three to four; 4 - Five to six; 5 - Every day, indicating how frequently a given self-care action is performed (e.g., never, rarely, sometimes, often, always). Based on the responses, a score calculation was performed to determine whether the patient’s self-care related to Diabetes or HTN was Excellent, Good, Moderate, or Poor. For the score calculation, the points were summed, and the individual’s self-care was stratified according to the following cutoff points shown in Chart 1.
In the third stage, after constructing the first version of the instrument, specialists were recruited for the validation process, an empirical procedure, following Pasquali’s recommendations, which suggest a minimum of seven judges. The contact information was provided by the coordinator responsible for continuing education services of the 15th RSPR. The invitation was sent via email and included the Informed Consent Form (ICF), the developed instrument, an evaluation questionnaire in Word® format, and instructions on how to carry out the evaluation process. The invitation was sent to 52 nurses from different Primary Health Care Units belonging to the 15th RSPR, of whom 13 (25% adherence) agreed to participate.
In the fourth stage, corresponding to the analytical phase, content and face validation were conducted by expert judges. The evaluation questionnaire consisted of two parts: 1 - Judge characterization (sex, age, professional background, academic degree, professional role, and municipality); 2 - Content evaluation (six questions). To complete the questionnaire, judges were asked to indicate the level of adequacy of each item using a Likert-type scale ranging from 1 to 4, as follows: 1 - Fully adequate; 2 - Adequate;3 - Partially adequate;4 - Inadequate. Additionally, each item was assessed according to 12 attributes: Objectivity, Scope, Behavior, Credibility, Balance, Modality, Precision, Relevance, Typicality, Variety, Clarity, and Simplicity21.
For the analysis of the instrument, descriptive statistics were performed for each theme, as well as for the attributes assigned to each item. A summary table of the attributes was created, containing the frequency and average percentage of how many professionals identified the presence of each attribute across the items. For the Likert-scale questions, agreement tables were also constructed, along with the calculation of the I-CVI (Item-Level Content Validity Index) and UA (Universal Agreement), in order to measure how adequate the instrument was from the experts’ perspective.
For the calculation of the I-CVI, the items were first recoded by assigning a value of 1 when professionals rated the item as Fully adequate or Adequate, and 0 when it was rated as Partially adequate or Inadequate. Based on this recoding, the number of professionals in agreement for each item was counted-that is, the number of times the value 1 appeared. The I-CVI was then calculated by dividing the number of professionals in agreement by the total number of professionals participating in the study. Finally, the S-CVI/Avg consisted of the average of all I-CVI scores obtained across the items. An agreement index of 80% or higher is considered an acceptable validity parameter26.
The UA measure refers to unanimity among the professionals, also called Universal Agreement, and is calculated as follows: for each item, a value of 0 or 1 is assigned. The value 1 can only be used if all professionals rated the item as Fully adequate or Adequate-that is, all 13 professionals needed to classify the item within these categories for it to receive a value of 1. For the S-CVI/UA index, the number of items that received a value of 1 is summed and divided by the total number of items evaluated.
The deadline for returning the evaluation was 15 calendar days; however, responses were received between seven and 20 days. Two rounds of evaluations were required, following the principles of the Delphi technique27. It is important to note that the same judges participated in both rounds.
In the fifth stage, after revising the instrument based on the judges’ suggestions, a pilot test was conducted to structure the instrument. The sample consisted of 31 patients, who were contacted through scheduled appointments at the Primary Health Care Unit (PHCU) in their assigned coverage area. Inclusion criteria were having a diagnosis of DM and/or HTN, being over 18 years of age, and being a user of any PHCU within the 15th RSPR. Individuals who did not attend the scheduled appointment were excluded. The instrument was administered by the principal researcher of this study, who is a doctoral-level investigator with experience in this field of knowledge
RESULTS
The content validation of the instrument was carried out by 13 expert judges, all nurses, of whom 92.3% (n=12) were female. Their ages ranged from 28 to 58 years (mean of 35.5 years), and their time since graduation varied from 4 to 37 years (mean of 12 years). Among them, 38.5% (n=5) held doctoral degrees and 23.1% (n=3) held master’s degrees. Of the specialists, 46.2% (n=4) were faculty members, while the others worked in Primary Health Care (PHC).
After the validation process, in the first round, it was observed that the instrument generally achieved good I-CVI indices. However, the following items scored below 0.80 and were subsequently revised: The instrument is presented clearly and objectively (DM and HTN); The instrument is well structured in terms of agreement and spelling (DM); and The instrument is aesthetically adequate (DM and HTN). Despite these issues, the S-CVI/Avg resulted in a value of 0.81 (Table 1).
The judges’ suggestions focused on 15 items (31.25%, n=48), aimed at improving professionals’ and patients’ understanding. It is important to highlight that all suggestions were accepted and are presented in Chart 2.
Suggestions made by the judges regarding the questions of the Self-Care Stratification Instrument for individuals with Diabetes Mellitus and Systemic Arterial Hypertension. Maringá, PR, Brazil, 2024. (n= 13)
After adjusting the instrument based on the specialists’ suggestions, a second round of evaluation was conducted, achieving 100% adherence from the 13 judges who initially participated in the validation process. In the instrument related to the self-care of individuals with SAH, only two items presented an I-CVI below 0.80. However, the S-CVI/Ave was 0.93, indicating that the instrument was validated in terms of both content and appearance (Table 2).
In the self-care stratification instrument for individuals with DM, only two items also failed to reach an I-CVI above 0.80. The S-CVI/Avg was 0.94, indicating that the instrument was validated in terms of both content and appearance (Table 3).
DISCUSSION
The stratification of self-care for individuals with SAH and DM is a key pillar for controlling these chronic conditions and their complications. It is known that the self-management of type 2 DM and SAH share common elements, as both require adherence to pharmacological therapy, maintaining a healthy diet, engaging in regular physical activity, and cessation of smoking and alcohol use28.
In this sense, stratifying self-care implies recognizing that each person has different levels of vulnerability and, therefore, different needs29. Through self-care stratification, it becomes possible to identify who and how many individuals fall into low, moderate, and high self-care risk categories. Each level has distinct needs, particularly regarding the frequency of follow-up. By stratifying, health teams can better organize the provision of interventions and the flow of individuals within the Health Care Network30. From this perspective, the results of this study have the potential to enhance and structure the care provided to the population with SAH and DM, as they allow the development of therapeutic plans tailored to the real demands of each user.
The development of instruments in the health field promotes the advancement of technical-scientific competencies for care and, consequently, enhances patient safety by providing scientific evidence to support professional practice21. Health professionals are challenged to apply the best available evidence in their practice standards, which can be a complex process. The lack of knowledge, skills, attitudes, self-efficacy, and evidence-based practice behaviors constitutes barriers that must be measured using valid and reliable instruments for the target population31.
In this context, the instrument developed and validated in this study represents a strategic tool capable of stratifying the self-care of individuals with SAH and/or DM. The model proposed by Pasquali21 proved to be appropriate for the construction of the instrument, as it offers a robust methodology that supports the development of tools designed to assess human behavior - an aspect that strongly influences health choices and attitudes.
A clinical approach based on self-care stratification, conducted by the health team, not only centers care on the individual and family but also supports decision-making through individualized recommendations, resulting in more assertive clinical actions32. Within this framework, Primary Health Care plays a fundamental role in the management of SAH and DM by coordinating the various actions and services available in the network (referral and counter-referral), contributing to longitudinal and resolutive care for individuals with chronic conditions33.
The instrument can be applied in the routine care provided by PHC teams, whether during scheduled or walk-in consultations, guided by self-care stratification and the control of glycemic and blood pressure levels. It is important to emphasize the relevance of establishing a strong bond between professionals and users, in order to foster active and responsible participation in the health-disease process33.
However, self-care practices remain incipient34. This highlights the need to strengthen peer-support systems related to disease prevention and person-centered health promotion actions, aiming to control modifiable and behavioral risk factors that influence glycemic and blood pressure levels32,34.
The use of the instruments developed allows the identification - above all - of users’ difficulties in performing self-care, especially among individuals whose disease control depends fundamentally on lifestyle changes32. Therefore, it is essential that professionals, based on the risks identified, guide users and their families regarding the disease, its complications, and treatment, so that they can assume an active role in promoting self-care at every visit to health services35-38.
Health education is one of the most important determinants for facilitating changes in self-care practices. Counseling and health education provided by professionals not only improve the population’s knowledge but also serve as a source of encouragement for lifestyle changes. A qualitative study conducted in Pakistan found that individuals with DM recognized and valued the guidance received from the health team regarding medication adherence and the adoption of healthier eating habits and were more likely to modify their behavior when these topics were consistently addressed during consultations39.
As a limitation, it is important to highlight the difficulty in obtaining adherence from health professionals to participate in the validation process. In this study, only 25% of the judges contacted composed the sample, making it necessary to send a second email requesting participation, which extended the initial response period (15 days). Additionally, the instruments presented an S-CVI/Avg below 0.80 in the aesthetics domain; this discrepancy may have occurred, in part, due to the way the material was sent to the judges. This issue was corrected in the second round, which was reflected in the overall S-CVI/Avg of the instruments.
Despite these limitations, the instrument developed was validated in terms of content and appearance, presenting an S-CVI/Avg above 0.80 (0.93 for SAH and 0.94 for DM). It is important to reiterate that the instruments should be applied by health professionals and not self-administered, in order to ensure better understanding by the population and to more accurately and promptly detect the level of self-care. The stratification of self-care among individuals with SAH and DM contributes to the (re)direction of interventions that are sensitive to the real needs of the population, with the potential to positively impact quality of life and well-being, as well as reduce healthcare costs associated with complications.
CONCLUSION
The objective of this study was achieved, as the instruments were validated in terms of content and appearance, with an S‑CVI/Ave higher than 0.80 - 0.93 for the self‑care risk of individuals with SAH and 0.94 for the self‑care risk of individuals with DM. Some items required adjustments, in accordance with the judges’ suggestions.
It is important to emphasize that it is difficult to guide public policies, evaluate treatment guidelines, and design and plan interventions for patients with chronic conditions when the level of self‑care is unknown. Thus, based on the products of this study, self‑care stratification for individuals with SAH and DM can be strengthened and applied in all consultations conducted in PHC, helping structure and direct actions to meet the needs of this population and prevent acute events, complications, and hospitalizations.
It is believed that the use of these instruments by PHC professionals will facilitate the identification of self‑care patterns, guiding care management with a focus on expanding shared responsibility, offering person‑centered care, and consequently achieving better health outcomes and quality of life. Furthermore, regarding the organization of health services, the implementation of these instruments has the potential to optimize human and time resources, expanding the capacity of PHC services to act at both individual and collective levels.
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NOTES
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ORIGIN OF THE ARTICLE
Article extracted from the thesis - Construção e validação de um instrumento eletrônico para estratificação do autocuidado de pessoas com hipertensão arterial e/ou diabetes mellitus, presented Programa de Pós-Graduação de Enfermagem, Universidade Universidade Estadual de Maringá, 2025.
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APPROVAL OF ETHICS COMMITTEE IN RESEARCH
Approved by the Ethics Committee in Research of the Universidade Estadual de Maringá, n 4.891.941 CAE 46644321.8.0000.0104.
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TRANSLATED BY
Ricardo H D Giammattei.
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DATA AVAILABILITY
The entire data set that supports the results of this study was published in the article itself.
Edited by
The entire data set that supports the results of this study was published in the article itself.
