Educational Model for Cardiac Patients

Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis
• Intervention / Treatment: Behavioral: usual care; Behavioral: educational model + follow up

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirao Preto, São Paulo, Brazil, 14040-902
      • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: usual care; Hospital health professionals offered orientation on care after discharge
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	Behavioral: educational model + follow up; Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and five to seven months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline and five to seven months
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.	baseline and five to seven months
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.	baseline and five to seven months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Lidia A Rossi, PhD, University of São Paulo at Ribeirão Preto College of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arterial Occlusive Diseases; Coronary Artery Disease; Coronary Disease; Cardiovascular Diseases; Arteriosclerosis
• Other Study ID Numbers: 51805715.0.0000.5393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No