Educational Model for Cardiac Patients

NCT ID: NCT02975648

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2020-01-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Coronary Disease Arteriosclerosis Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

usual care

Intervention Type BEHAVIORAL

Hospital health professionals offered orientation on care after discharge

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

Group Type EXPERIMENTAL

educational model + follow up

Intervention Type BEHAVIORAL

Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)

Interventions

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educational model + follow up

Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)

Intervention Type BEHAVIORAL

usual care

Hospital health professionals offered orientation on care after discharge

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Natássia Condilo Pitta

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lidia A Rossi, PhD

Role: STUDY_CHAIR

University of São Paulo at Ribeirão Preto College of Nursing

Locations

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

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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51805715.0.0000.5393

Identifier Type: -

Identifier Source: org_study_id

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