Educational Model for Cardiac Patients

University of Sao Paulo

Status: Completed

Conditions: Coronary Artery Disease; Cardiovascular Diseases; Arteriosclerosis; Coronary Disease

Treatments: Behavioral: usual care; Behavioral: educational model + follow up

Study type: Interventional

Funder types: Other

Identifiers

NCT02975648

51805715.0.0000.5393

Details and patient eligibility

About

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.

Full 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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: usual care

Educational model + follow up

Experimental group

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

Treatment:

Behavioral: educational model + follow up