Educational Model for Cardiac Patients
Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial
1 other identifier
interventional
127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedMarch 30, 2020
March 1, 2020
1.4 years
November 24, 2016
March 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change in symptoms of anxiety and depression from baseline to five to seven months
baseline and five to seven months
Change in perceived health status from baseline to five to seven months
baseline and five to seven months
Change in self-efficacy for physical activity from baseline to five to seven months
baseline and five to seven months
Study Arms (2)
Usual Care
ACTIVE COMPARATORAt discharge, paticipants received guidance from health professionals. The paticipants had a medical return five to seven months after the percutaneous coronary intervention.
Educational model + follow up
EXPERIMENTALThe 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
Interventions
Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)
Hospital health professionals offered orientation on care after discharge
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14040-902, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lidia A Rossi, PhD
University of São Paulo at Ribeirão Preto College of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
November 24, 2016
First Posted
November 29, 2016
Study Start
August 1, 2017
Primary Completion
December 20, 2018
Study Completion
January 30, 2020
Last Updated
March 30, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share