Clinical trial NCT02975648: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Disease
Arteriosclerosis
Cardiovascular Diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in physical activity level from baseline to five to seven months
timeFrame: baseline and five to seven months
Secondary outcomes:
measure: Change in symptoms of anxiety and depression from baseline to five to seven months
timeFrame: baseline and five to seven months
measure: Change in perceived health status from baseline to five to seven months
timeFrame: baseline and five to seven months
measure: Change in self-efficacy for physical activity from baseline to five to seven months
timeFrame: baseline and five to seven months
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Lidia A Rossi, PhD
role: STUDY_CHAIR
References: