Percutaneous Coronary InterventionNCT01341093
Education Program for Cardiac Patients
A study testing educational program+telephone follow up in people with Percutaneous Coronary Intervention and Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Artery Disease
- What is being tested?
- educational program+telephone follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, 14048900
About this study
Official title: Educational Program With Telephone Follow-up for Patients After Percutaneous Coronary Intervention: Randomized Controlled Trial
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.
- Being tested
- educational program+telephone follow up, Usual care
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational program+telephone follow upBehavioural
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.
Usual careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| usual care | Active comparator | Not described Receives: Behavioral: Usual care |
| educational program+telephone follow up | Experimental | Not described Receives: Behavioral: educational program+telephone follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and six months
Secondary outcomes (3)
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.
Measured: baseline and 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.
Measured: baseline and 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.
Measured: baseline and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rejane Kiyomi Furuya, University of Sao Paulo
- Investigators
- Rejane K. Furuya, PhDCandidate, Principal investigator, University of São Paulo at Ribeirão Preto College of NursingLidia A. Rossi, PhD, Study chair, University of São Paulo at Ribeirão Preto College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341093
- Sponsor's protocol ID
- 2010/19761-3
- Status last verified
- May 2014
- First submitted
- 15 Apr 2011
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25400127
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Program With Telephone Follow-up for Patients After Percutaneous Coronary Intervention: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01341093
- Acronym / sponsor ID
- 2010/19761-3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | Active comparator | Behavioral: Usual care |
| educational program+telephone follow up | Experimental | Behavioral: educational program+telephone follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- No cognitive condition to participate (assessed through the Mini-Mental State Examination - MMSE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational program+telephone follow upPatients will participate in the educational program with telephone follow-up, the education program will initiate in preoperative period and will continue for six months. | Behavioural | educational program+telephone follow up |
| Usual carePatients 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. | Behavioural | usual care |
Primary outcome
change from baseline in perceived health status at six months
Time frame: baseline and 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.
3 secondary outcomes
change from baseline in treatment adherence at six months
Time frame: baseline and six months
change from baseline in self-efficacy at six months
Time frame: baseline and six months
change from baseline in anxiety and depression at six months
Time frame: baseline and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
- Derived from this study: PubMed 25400127Furuya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rejane K. Furuya, PhDCandidate principal investigator
University of São Paulo at Ribeirão Preto College of Nursing
Lidia A. Rossi, PhD study chair
University of São Paulo at Ribeirão Preto College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program+telephone follow up in people with Percutaneous Coronary Intervention and Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in perceived health status at six months (time frame: baseline and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01341093, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.