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Publicly Versus Privately-Funded Cardiac Rehabilitation

31. března 2020 aktualizováno: 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.

Přehled studie

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

174

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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).

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Observační modely: Jiný
  • Časové perspektivy: Průřezový

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Barriers
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Giovanna LB Borges, São Paulo State University (UNESP)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

4. června 2018

Primární dokončení (Aktuální)

10. srpna 2018

Dokončení studie (Aktuální)

20. ledna 2019

Termíny zápisu do studia

První předloženo

4. července 2019

První předloženo, které splnilo kritéria kontroly kvality

11. července 2019

První zveřejněno (Aktuální)

12. července 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. dubna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. března 2020

Naposledy ověřeno

1. března 2020

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CAAE: 88504718.0.0000.5402

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Application of questionnaires

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