Coronary Artery DiseaseNCT02975648
Educational Model for Cardiac Patients
A study testing educational model + follow up in people with Coronary Artery Disease and Coronary Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Disease, Arteriosclerosis
- What is being tested?
- educational model + follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to 30 Jan 2020
- 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 genders
- Patients undergoing the first percutaneous coronary intervention
- Patients who had a properly functioning home phone line
Who cannot join
- 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
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, 14040-902
About this study
Official title: Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial
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.
Read the 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.
- Being tested
- educational model + follow up, usual care
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Arteriosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational model + follow upBehavioural
Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)
usual careBehavioural
Hospital health professionals offered orientation on care after discharge
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: educational model + follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and five to seven months
Secondary outcomes (3)
Change in symptoms of anxiety and depression from baseline to five to seven months
The questionnaire "Hospital Anxiety and Depression Scale" was developed by Zigmond and Snaith (1983) and validated and adapted to Portuguese by Botega et al. (1995). The Hospital Anxiety and Depression Scale contains 14 multiple choice questions, divided into two subscales: anxiety and depression (composed of seven items each). Higher scores indicate more symptoms of anxiety and depression. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
Measured: baseline and five to seven months
Change in perceived health status from baseline to five to seven months
The questionnaire "Medical Outcomes Survey 36 - Item Short-Form" developed by Ware and Sherboune (1992). The investigators used the version licensed by Quality Metric Incorporated (MARUISH, 2011) for use in surveys in Brazil. The Medical Outcomes Survey 36 - Item Short-Form is a multidimensional questionnaire composed of 36 items that evaluate eight health concepts: functional capacity, physical aspects, pain, general health, vitality, social aspects, emotional aspects, mental health and a comparative question that evaluate the current health conditions with one year ago. Higher values indicate better perceived health status. This questionnaire was used to collect the data at baseline and five to seven months after hospital discharge.
Measured: baseline and five to seven months
Change in self-efficacy for physical activity from baseline to five to seven months
The questionnaire "Escala de Autoeficácia Para Prática de Atividade Física" developed by Rech et al. (2011) for Brazilian adults and by Borges et al. (2015) that used in the elderly population. This questionnaire was elaborated from two specific scales of self-efficacy for the practice of physical exercise, proposed by Sallis et al. (1988) and Bandura (2006). We used the Brazilian adult version (RECH et al., 2011) which contains two domains with five items each in which the answers are dichotomous ( "no" versus "yes"). Higher scores indicate better self-efficacy for physical activity. The instrument was used to collect the data at baseline and five to seven months after hospital discharge.
Measured: baseline and five to seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 Aug 2017
- Primary completion20 Dec 2018
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natássia Condilo Pitta, University of Sao Paulo
- Investigators
- Lidia A Rossi, PhD, Study chair, University of São Paulo at Ribeirão Preto College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975648
- Sponsor's protocol ID
- 51805715.0.0000.5393
- Status last verified
- Mar 2020
- First submitted
- 24 Nov 2016
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Model on Physical Activity in Individuals Undergoing the First Percutaneous Coronary Intervention: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02975648
- Acronym / sponsor ID
- 51805715.0.0000.5393
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 29 Nov 2016 (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 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.
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 careAt discharge, paticipants received guidance from health professionals. The paticipants had a medical return five to seven months after the percutaneous coronary intervention. |
| Educational model + follow up | Experimental | Behavioral: educational model + follow upThe 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 |
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 genders
- Patients undergoing the first percutaneous coronary intervention
- Patients who had a properly functioning home phone line
Key exclusion criteria (5 listed)
- 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
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 model + follow upOrientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls) | Behavioural | Educational model + follow up |
| usual careHospital health professionals offered orientation on care after discharge | Behavioural | Usual Care |
Primary outcome
Change in physical activity level from baseline to five to seven months
Time frame: baseline and 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.
3 secondary outcomes
Change in symptoms of anxiety and depression from baseline to five to seven months
Time frame: baseline and five to seven months
Change in perceived health status from baseline to five to seven months
Time frame: baseline and five to seven months
Change in self-efficacy for physical activity from baseline to five to seven months
Time frame: baseline and five to seven 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 30 Mar 2020.
- Individual participant dataSharing planned: No
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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.
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 model + follow up in people with Coronary Artery Disease and Coronary 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 5 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 30 Mar 2020. 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 in physical activity level from baseline to five to seven months (time frame: baseline and five to seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2020.