- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04017663
Publicly Versus Privately-Funded Cardiac Rehabilitation
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
São Paulo
-
Presidente Prudente, São Paulo, 브라질, 19060-900
- Unesp
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Barriers
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Giovanna LB Borges, São Paulo State University (UNESP)
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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-
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