Back to resultsEducation Program for Cardiac Patients
Primary Purpose
Percutaneous Coronary Intervention, Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
educational program+telephone follow up
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
Sites / Locations
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
usual care
educational program+telephone follow up
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change from baseline in treatment adherence at six months
The questionnaire "Medida de adesão ao tratamento (MAT)" developed by Delgado and Lima (2001) will be used to collect the data related to the pharmacological adherence at baseline and at six months.
change from baseline in self-efficacy at six months
The questionnaire "General Self-Efficacy Scale" developed by Schwarzer and Jerusalem (1995) will be used to collect the data at baseline and at six months.
change from baseline in anxiety and depression at six months
The questionnaire "Hospital Anxiety and Depression Scale (HADS)" developed by Zigmond and Snaith (1983) will be used to collect the data at baseline and at six months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01341093
Brief Title
Education Program for Cardiac Patients
Official Title
Educational Program With Telephone Follow-up for Patients After Percutaneous Coronary Intervention: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Coronary Intervention, Coronary Artery Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
Active Comparator
Arm Title
educational program+telephone follow up
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
educational program+telephone follow up
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
change from baseline in perceived health status at six months
Description
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.
Time Frame
baseline and six months
Secondary Outcome Measure Information:
Title
change from baseline in treatment adherence at six months
Description
The questionnaire "Medida de adesão ao tratamento (MAT)" developed by Delgado and Lima (2001) will be used to collect the data related to the pharmacological adherence at baseline and at six months.
Time Frame
baseline and six months
Title
change from baseline in self-efficacy at six months
Description
The questionnaire "General Self-Efficacy Scale" developed by Schwarzer and Jerusalem (1995) will be used to collect the data at baseline and at six months.
Time Frame
baseline and six months
Title
change from baseline in anxiety and depression at six months
Description
The questionnaire "Hospital Anxiety and Depression Scale (HADS)" developed by Zigmond and Snaith (1983) will be used to collect the data at baseline and at six months.
Time Frame
baseline and six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rejane K. Furuya, PhDCandidate
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lidia A. Rossi, PhD
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14048900
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
25400127
Citation
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.
Results Reference
derived
Learn more about this trial
Education Program for Cardiac Patients
We'll reach out to this number within 24 hrs