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Publicly Versus Privately-Funded Cardiac Rehabilitation

2020年3月31日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (実際)

174

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • São Paulo
      • Presidente Prudente、São Paulo、ブラジル、19060-900
        • Unesp

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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).

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:他の
  • 時間の展望:断面図

コホートと介入

グループ/コホート
介入・治療
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Barriers
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Giovanna LB Borges、São Paulo State University (Unesp)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年6月4日

一次修了 (実際)

2018年8月10日

研究の完了 (実際)

2019年1月20日

試験登録日

最初に提出

2019年7月4日

QC基準を満たした最初の提出物

2019年7月11日

最初の投稿 (実際)

2019年7月12日

学習記録の更新

投稿された最後の更新 (実際)

2020年4月2日

QC基準を満たした最後の更新が送信されました

2020年3月31日

最終確認日

2020年3月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Application of questionnairesの臨床試験

3
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