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Educational Model for Cardiac Patients

Primary Purpose

Coronary Artery Disease, Coronary Disease, Arteriosclerosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
educational model + follow up
usual care
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Educational model + follow up

Arm Description

At discharge, paticipants received guidance from health professionals. The paticipants had a medical return five to seven months after the percutaneous coronary intervention.

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

Outcomes

Primary Outcome Measures

Change in physical activity level from baseline to five to seven months
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.

Secondary Outcome Measures

Change in symptoms of anxiety and depression from baseline to five to seven months
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.
Change in perceived health status from baseline to five to seven months
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.
Change in self-efficacy for physical activity from baseline to five to seven months
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.

Full Information

First Posted
November 24, 2016
Last Updated
March 26, 2020
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02975648
Brief Title
Educational Model for Cardiac Patients
Official Title
Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to compare the effect of an educational model, which included cardiac rehabilitation with emphasis on physical activity and telephone follow up, with the usual management of individuals undergoing to first percutaneous coronary intervention, in relation to physical activity five until seven months after discharge.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Cardiovascular Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
At discharge, paticipants received guidance from health professionals. The paticipants had a medical return five to seven months after the percutaneous coronary intervention.
Arm Title
Educational model + follow up
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
educational model + follow up
Intervention Description
Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)
Intervention Type
Behavioral
Intervention Name(s)
usual care
Intervention Description
Hospital health professionals offered orientation on care after discharge
Primary Outcome Measure Information:
Title
Change in physical activity level from baseline to five to seven months
Description
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.
Time Frame
baseline and five to seven months
Secondary Outcome Measure Information:
Title
Change in symptoms of anxiety and depression from baseline to five to seven months
Description
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.
Time Frame
baseline and five to seven months
Title
Change in perceived health status from baseline to five to seven months
Description
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.
Time Frame
baseline and five to seven months
Title
Change in self-efficacy for physical activity from baseline to five to seven months
Description
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.
Time Frame
baseline and five to seven months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lidia A Rossi, PhD
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirao Preto
State/Province
São Paulo
ZIP/Postal Code
14040-902
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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