NCT01341093

Brief Summary

The purpose of this study is to elaborate an educative program that includes telephone follow-up and assess its impact on the perceived health status of patients submitted to percutaneous coronary intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 15, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

April 15, 2011

Last Update Submit

May 14, 2014

Conditions

Percutaneous Coronary InterventionCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • change from baseline in perceived health status at six months

    The questionnaire "Medical Outcomes Survey 36 - Item Short-Form" developed by Ware and Sherboune (1992) will be used to collect the data at baseline and at six months.

    baseline and six months

Secondary Outcomes (3)

  • change from baseline in treatment adherence at six months

    baseline and six months

  • change from baseline in self-efficacy at six months

    baseline and six months

  • change from baseline in anxiety and depression at six months

    baseline and six months

Study Arms (2)

usual care

ACTIVE COMPARATOR
Behavioral: Usual care

educational program+telephone follow up

EXPERIMENTAL
Behavioral: educational program+telephone follow up

Interventions

educational program+telephone follow upBEHAVIORAL

Patients will participate in the educational program with telephone follow-up, the education program will initiate in preoperative period and will continue for six months.

educational program+telephone follow up
Usual careBEHAVIORAL

Patients will receive orientations about the surgery and the rehabilitation by health professionals, especially in the discharge. And will have return for evaluation scheduled by health professionals.

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 sexes
  • Being submitted to the first coronary artery bypass graft surgery between April 2011 and July 2012
  • Having a properly functioning residential phone line

You may not qualify if:

  • No cognitive condition to participate (assessed through the Mini-Mental State Examination - MMSE)
  • Illiterate participants who did not reach the minimum score 13 on the MMSE
  • Participants with one to seven years of education who did not reach the minimum score 18 on the MMSE
  • Participants with eight or more years of education who did not reach the minimum of 26 points on the MMSE

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, 14048900, Brazil

Location

Related Publications (1)

  • Furuya RK, Arantes EC, Dessotte CA, Ciol MA, Hoffman JM, Schmidt A, Dantas RA, Rossi LA. A randomized controlled trial of an educational programme to improve self-care in Brazilian patients following percutaneous coronary intervention. J Adv Nurs. 2015 Apr;71(4):895-908. doi: 10.1111/jan.12568. Epub 2014 Nov 17.

    PMID: 25400127DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Rejane K. Furuya, PhDCandidate

    University of São Paulo at Ribeirão Preto College of Nursing

    PRINCIPAL INVESTIGATOR

  • 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
Ph.D

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 25, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2012

Study Completion

October 1, 2013

Last Updated

May 15, 2014

Record last verified: 2014-05

Locations

BR(1)