NCT02975648

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

November 24, 2016

Last Update Submit

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 COMPARATOR

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

Educational model + follow up

EXPERIMENTAL

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

Interventions

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

Educational model + follow up
usual careBEHAVIORAL

Hospital health professionals offered orientation on care after discharge

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary DiseaseArteriosclerosisCardiovascular Diseases

Interventions

Models, Educational

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Study Officials

  • Lidia A Rossi, PhD

    University of São Paulo at Ribeirão Preto College of Nursing

    STUDY CHAIR

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

Locations