- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02975648
Educational Model for Cardiac Patients
Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Randomized controlled trial (RCT) at a public teaching hospital, which has specialized care for CAD in Ribeirão Preto, state of São Paulo, Brazil. The intervention group received usual care and an educational programme and the control group received only usual care.
A researcher (who didn't had contact with the patients) generated the random allocation in SPSS software, concealing it from the investigators in sequentially numbered, sealed and opaque envelopes.
Another researcher performed the individual interview with each participant (baseline) and aplied the instruments of socialdemographic data, physical activity, ansiety and depression, perceived health status and selfefficacy to practice of physical activity. At the end of the interviewThe same researcher opened the envelope to allocate the participants to either intervention or control group. The participants of intervention group remained with the researcher to receive the intervention.
The educational programme consisted of four booklets entitled 1. Percutaneous Transluminal Coronary Angioplasty, 2. Going home after your coronary angioplasty, 3. How to take care of your heart and your health, and 4. How to practice physical activities. The educational programme included the telephone follow-up that contained three calls to motivate the participants to change their lifestyle and clarify doubts. The contents of the booklets were explained step by step to the participants by the researcher who conducted the interviews.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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São Paulo
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Ribeirao Preto, São Paulo, Brasil, 14040-902
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult patients (18 years or more) of both genders
- Patients undergoing the first percutaneous coronary intervention
- Patients who had a properly functioning home phone line
Exclusion Criteria:
- No cognitive conditions to participate (assessed by the ability to inform the name, current date, day of the week, place, age and place of birth confirmed by the participant's identification document)
- Who did not have clinical or physical conditions to answer the questionnaires (individuals with dyspnea and / or mental confusion)
- Who reported difficulties to speak on the phone (hearing loss)
- Who had sequelae that could influence activities of daily living (limb amputation or paralysis)
- Who had a contraindication to physical exercise, prescribed by the doctor, and who already participated in a supervised cardiac rehabilitation program
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Usual Care
At discharge, paticipants received guidance from health professionals.
The paticipants had a medical return five to seven months after the percutaneous coronary intervention.
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Hospital health professionals offered orientation on care after discharge
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Experimental: Educational model + follow up
The paticipants received the hospital's instructions at discharge and participated in the educational program (booklets with telephone follow-up).
The paticipants had a medical return five to seven months after discharge
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Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in physical activity level from baseline to five to seven months
Periodo de tiempo: baseline and five to seven months
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The "Baecke Questionnaire of Habitual Physical Activity" was developed by Baecke, Burema and Frijters (1982) and validated for the Brazilian population by Florindo et al. (2004, 2006).
The instrument has three dimensions: occupational physical activity (eight questions), physical activity during leisure time (four questions) and leisure and locomotion activities (four questions), totaling 16 questions.
Higher scores indicate a higher level of physical activity.
This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
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baseline and five to seven months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in symptoms of anxiety and depression from baseline to five to seven months
Periodo de tiempo: baseline and five to seven months
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The questionnaire "Hospital Anxiety and Depression Scale" was developed by Zigmond and Snaith (1983) and validated and adapted to Portuguese by Botega et al. (1995).
The Hospital Anxiety and Depression Scale contains 14 multiple choice questions, divided into two subscales: anxiety and depression (composed of seven items each).
Higher scores indicate more symptoms of anxiety and depression.
This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
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baseline and five to seven months
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Change in perceived health status from baseline to five to seven months
Periodo de tiempo: baseline and five to seven months
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The questionnaire "Medical Outcomes Survey 36 - Item Short-Form" developed by Ware and Sherboune (1992).
The investigators used the version licensed by Quality Metric Incorporated (MARUISH, 2011) for use in surveys in Brazil.
The Medical Outcomes Survey 36 - Item Short-Form is a multidimensional questionnaire composed of 36 items that evaluate eight health concepts: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental health and a comparative question that evaluate the current health conditions with one year ago.
Higher values indicate better perceived health status.
This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
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baseline and five to seven months
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Change in self-efficacy for physical activity from baseline to five to seven months
Periodo de tiempo: baseline and five to seven months
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The questionnaire "Escala de Autoeficácia Para Prática de Atividade Física" developed by Rech et al. (2011) for Brazilian adults and by Borges et al. (2015) that used in the elderly population.
This questionnaire was elaborated from two specific scales of self-efficacy for the practice of physical exercise, proposed by Sallis et al. (1988) and Bandura (2006).
We used the Brazilian adult version (RECH et al., 2011) which contains two domains with five items each in which the answers are dichotomous ( "no" versus "yes").
Higher scores indicate better self-efficacy for physical activity.
The instrument was used to collect the data at baseline and five to seven months after hospital discharge.
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baseline and five to seven months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Lidia A Rossi, PhD, University of São Paulo at Ribeirão Preto College of Nursing
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 51805715.0.0000.5393
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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