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Publicly Versus Privately-Funded Cardiac Rehabilitation

31 de março de 2020 atualizado por: Mayara Moura Alves da Cruz, Universidade Estadual Paulista Júlio de Mesquita Filho

Publicly Versus Privately-Funded Cardiac Rehabilitation: Access and Adherence Barriers

This is an observational cross-sectional study designed to investigate the barriers encountered by patients after admission to a public and private PRC and to correlate the barriers with the population profile.

To participate in this study, patients were recruited for convenience of two CRPs offered in the city of Presidente Prudente - SP, one linked to the private service offered by the Heart Institute (INCOR) and another public in the Cardiology Sector of the Center for Studies and Attendance in Physiotherapy and Rehabilitation - CEAFiR of the Faculty of Sciences and Technology, State University of São Paulo, Júlio de Mesquita Filho (FCT-UNESP).

As eligibility criteria, patients over 18 years of age, regardless of sex, diagnosed with cardiovascular diseases or referred for risk factor prevention and who had attended CRP for at least 3 months, regardless of the frequency percentage, were considered. Patients who were not found after three visits to the programs for evaluation were excluded from the study.

After the initial invitation and evaluation of the eligibility criteria, the participants were informed about the procedures and objectives of the study, and after agreeing, they signed the informed consent form. The study protocol was approved by the Research Ethics Committee of FCT-UNESP under CAAE number: 88504718.0.0000.5402.

For this, in only one meeting, an initial evaluation was made in order to identify and characterize the patients. Four questionnaires were then applied: the Brazilian Association of Research Companies (ABEP) Questionnaire for the evaluation of socioeconomic level, Mini Mental State Examination (MMSE), Hospital Anxiety and Depression Scale (HADS) and Barrier Scale for Cardiac Rehabilitation (EBRC).

Barriers were considered as the primary end point and correlations with the population profile as secondary outcomes.

Visão geral do estudo

Descrição detalhada

This is an observational cross-sectional study designed to investigate the barriers encountered by patients after admission to a public and private PRC and to correlate the barriers with the population profile.

To participate in this study, patients were recruited for convenience of two CRPs offered in the city of Presidente Prudente - SP, one linked to the private service offered by the Heart Institute (INCOR) and another public in the Cardiology Sector of the Center for Studies and Attendance in Physiotherapy and Rehabilitation - CEAFiR of the Faculty of Sciences and Technology, State University of São Paulo, Júlio de Mesquita Filho (FCT-UNESP).

As eligibility criteria, patients over 18 years of age, regardless of sex, diagnosed with cardiovascular diseases or referred for risk factor prevention and who had attended CRP for at least 3 months, regardless of the frequency percentage, were considered. Patients who were not found after three visits to the programs for evaluation were excluded from the study.

After the initial invitation and evaluation of the eligibility criteria, the participants were informed about the procedures and objectives of the study, and after agreeing, they signed the informed consent form. The study protocol was approved by the Research Ethics Committee of FCT-UNESP under CAAE number: 88504718.0.0000.5402.

For this, in only one meeting, an initial evaluation was made in order to identify and characterize the patients. Four questionnaires were then applied: the Brazilian Association of Research Companies (ABEP) Questionnaire for the evaluation of socioeconomic level, Mini Mental State Examination (MMSE), Hospital Anxiety and Depression Scale (HADS) and Barrier Scale for Cardiac Rehabilitation (EBRC).

Regarding the initial evaluation, the patients were asked about their age, weight and height to obtain the body mass index (BMI) 23, occupation, schooling, city where they currently reside, clinical diagnosis and time of rehabilitation treatment.

In addition, socioeconomic level, cognitive status and level of anxiety and depression were evaluated, which together with the information obtained in the initial evaluation provided the population profile.

In relation to the questionnaires, the questionnaire of the Brazilian Association of Companies and Research (ABEP) was used to analyze the socioeconomic level, which includes the level of schooling, and includes questions about family income, possession of public items and services offered in its residence. The sum of the points can result in a value between zero and one hundred points and the higher the score obtained in the questionnaire the greater the economic power of the patient. From the obtained score, the questionnaire allows the classification of the individual in classes A (average family income of R $ 20,888), B1 (average family income of R $ 9,254), B2 (average family income of R $ 4,852), C1 average family income of R $ 2,705), C2 (average family income of R $ 1,625), D and E (average family income of R $ 3,130), with A for a score higher than 45 and E, a score lower than 16.

The Mental State Mini Exam (MMSE) was used to assess cognitive status. The test is subdivided into two sections, the first one evaluates the orientation, memory and attention and in the second, the ability to appoint, from obedience to a verbal and written command, free writing of a sentence and copy of a complex drawing ( polygons). The higher the score obtained in the test, the better the patient's cognitive status, also considering the level of education (cutoff points: 20 points for illiterates, 25 points for individuals with 1 to 4 years of study, 26.5 points for individuals with 5 to 8 years of study, 28 points for individuals with 9 to 11 years of study, 29 points for individuals with more than 11 years of study).

To quantify the level of anxiety and depression, the Hospital Anxiety and Depression Scale (HADS) was applied. This scale presents seven affirmations for classifying anxiety and seven for depression, which present four options of responses ranging from zero to three points, which generates two scores, one for anxiety and another for depression. The classification is distributed between unlikely anxiety disorder or depression (0 to 7 points), possible disorder (8 to 11 points) and probable disorder (12 to 21 points).

Barriers were evaluated through the Barrier Scale for Cardiac Rehabilitation (EBRC), which is composed of twenty-one items that are scored using a Likert scale, which varies from one to five. This scale can be analyzed by the mean score of all items or divided into five subscales: comorbidities / functional status (B1: items 8, 9, 13, 14, 15, 17 and 21), perceived needs (B2: items 3 (B3: items 4, 7 and 18), travel / work conflicts (B4: items 10 and 12) and access (B5: items 1, 2, 19 and 20) 13. The higher the result of the averages, the greater the number of barriers found.

Barriers were considered as the primary end point and correlations with the population profile as secondary outcomes.

Tipo de estudo

Observacional

Inscrição (Real)

174

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • São Paulo
      • Presidente Prudente, São Paulo, Brasil, 19060-900
        • Unesp

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

To participate in this study, patients were recruited for convenience of two CRPs offered in the city of Presidente Prudente - SP, one linked to the private service offered by the Heart Institute (INCOR) and another public in the Cardiology Sector of the Center for Studies and Attendance in Physiotherapy and Rehabilitation - CEAFiR of the Faculty of Sciences and Technology, State University of São Paulo, Júlio de Mesquita Filho (FCT-UNESP).

Descrição

Inclusion Criteria:

  • As eligibility criteria, patients over 18 years of age, regardless of sex, diagnosed with cardiovascular diseases or referred for risk factor prevention and who had attended CRP for at least 3 months, regardless of the frequency percentage, were considered.

Exclusion Criteria:

  • Patients who were not found after three visits to the programs for evaluation were excluded from the study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: Outro
  • Perspectivas de Tempo: Transversal

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Public group
patients who performed cardiovascular rehabilitation in a public center
Application of questionnaires to identify characteristics and main barriers of patients
Private group
patients who performed cardiovascular rehabilitation in a private center
Application of questionnaires to identify characteristics and main barriers of patients

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Barriers
Prazo: In the first 1 day of avaliation
Barriers were evaluated through the Barrier Scale for Cardiac Rehabilitation (EBRC), which is composed of twenty-one items that are scored using a Likert scale, which varies from one to five. This scale can be analyzed by the mean score of all items or divided into five subscales: comorbidities / functional status (B1: items 8, 9, 13, 14, 15, 17 and 21), perceived needs (B2: items 3 (B3: items 4, 7 and 18), travel / work conflicts (B4: items 10 and 12) and access (B5: items 1, 2, 19 and 20) 13. The higher the result of the averages, the greater the number of barriers found.
In the first 1 day of avaliation
Socieconomic level
Prazo: In the first 1 day of avaliation
In relation to the questionnaires, the questionnaire of the Brazilian Association of Companies and Research (ABEP) was used to analyze the socioeconomic level, which includes the level of schooling, and includes questions about family income, possession of public items and services offered in its residence. The sum of the points can result in a value between zero and one hundred points and the higher the score obtained in the questionnaire the greater the economic power of the patient. From the obtained score, the questionnaire allows the classification of the individual in classes A (average family income of R $ 20,888), B1 (average family income of R $ 9,254), B2 (average family income of R $ 4,852), C1 average family income of R $ 2,705), C2 (average family income of R $ 1,625), D and E (average family income of R $ 3,130), with A for a score higher than 45 and E, a score lower than 16.
In the first 1 day of avaliation
Cognitive Status
Prazo: In the first 1 day of avaliation
The Mental State Mini Exam (MMSE) was used to assess cognitive status. The test is subdivided into two sections, the first one evaluates the orientation, memory and attention and in the second, the ability to appoint, from obedience to a verbal and written command, free writing of a sentence and copy of a complex drawing ( polygons). The higher the score obtained in the test, the better the patient's cognitive status, also considering the level of education (cutoff points: 20 points for illiterates, 25 points for individuals with 1 to 4 years of study, 26.5 points for individuals with 5 to 8 years of study, 28 points for individuals with 9 to 11 years of study, 29 points for individuals with more than 11 years of study).
In the first 1 day of avaliation
Anxiety and depression level
Prazo: In the first 1 day of avaliation
To quantify the level of anxiety and depression, the Hospital Anxiety and Depression Scale (HADS) was applied. This scale presents seven affirmations for classifying anxiety and seven for depression, which present four options of responses ranging from zero to three points, which generates two scores, one for anxiety and another for depression. The classification is distributed between unlikely anxiety disorder or depression (0 to 7 points), possible disorder (8 to 11 points) and probable disorder (12 to 21 points).
In the first 1 day of avaliation

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Giovanna LB Borges, São Paulo State University (Unesp)

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de junho de 2018

Conclusão Primária (Real)

10 de agosto de 2018

Conclusão do estudo (Real)

20 de janeiro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

4 de julho de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de julho de 2019

Primeira postagem (Real)

12 de julho de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de abril de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de março de 2020

Última verificação

1 de março de 2020

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CAAE: 88504718.0.0000.5402

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Doenças cardiovasculares

Ensaios clínicos em Application of questionnaires

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