Cardiovascular DiseasesNCT03605992
Home-based Cardiac Rehabilitation: Compliance and Effectiveness
A study testing Home-based Rehab and CentreRehab in people with Cardiovascular Diseases and Coronary Disease, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
The proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Cardiac Disease
- What is being tested?
- Home-based Rehab and CentreRehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Feb 2018to 30 Oct 2019
- 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
- Patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, or that had a heart attack, provided they are considered of a low and moderate risk for the practice of physical exercise of moderate intensity according to the stratification for the risk of events during a cardiovascular rehabilitation program
- Clinical stability, according with the medical evaluation;
- Residents of the Belo Horizonte's metropolitan region.
Who cannot join
- Recent cardiac event or clinical decompensation (<1month);
- Presence of peripheral arterial occlusive disease with limitation degree that prevents the test of maximum exercise (emergence of claudication before the maximum cardiorespiratory fatigue);
- Presence of chronic pulmonary disease (i.e. Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, and pulmonary arterial hypertension of pre capillary etiology);
- History of ventricular fibrillation or sustained ventricular tachycardia in the last year;
- Presence of high risk criteria during the ergometric test;
- Physical, cognitive, or social limitation that prevent the participation in a physical exercise program, and the comprehension of the use of the monitoring device.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
About this study
Official title: Compliance, Viability and Effectiveness of Home Based Cardiac Rehabilitation: a Randomised Trial
The proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional capacity, and the control of coronary risk factors in relation to the traditional cardiac rehabilitation offered mostly supervised and center based.
Read the detailed description
This study will be developed with patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, provided they are considered of low and moderate risk for the practice of physical exercise of moderate intensity, according to the risk stratification proposed by the American Association of Cardiovascular and Pulmonary Rehabilitation. Volunteers will be recruited at the outpatient at the University Hospital's Cardiac Rehabilitation Centre. The study will be made in conformity with the CONSORT guidelines for non-pharmacological interventions. After being invited to the study, the volunteer whose accept the participation and sign the consent form will be randomized into two different groups: Traditional cardiac rehabilitation (mostly supervised) and Telerehabilitation (mostly unsupervised). The randomization will be made through the www.randomization.com website in blocks of four volunteers each. A blind researcher will evaluate participants before and after test, and will fulfill the database.
Intervention The parameters for the exercise prescription will be the same for both groups. Exercise sessions will be constituted of 5-10 minutes of warm up, 40 minutes of aerobic activity with heart rate between 60 and 80% of the heart rate reserve, and 5-10 minutes of cool down. The educational sessions will be given to both groups in six meetings with 40 minutes each, and items regarding the control of risk factors and treatment of cardiovascular diseases will be approached. After the period of 12 weeks of intervention all participants will be stimulated to continue to practice physical exercises at home or at the community, and they will be invited to a re-evaluation after three months.
Groups:
Traditional cardiac rehabilitation as control group (CentreRehab) The CentreRehab group will be made supervised exercises and health educational activities, personally at cardiac rehabilitation centre. This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week). The participants of this group will be oriented to fulfill a training diary with information regarding the frequency of the exercises, the presence of symptoms, and the use of the scale of perceived exertion during exercises at home.
Home-based cardiac rehabilitation (HomeRehab) The participants of the HomeRehab group will make the exercise mostly at home. There will be weekly phone calls, in person educational sessions, and monthly meetings to check the execution of the previous stage, solve doubts, or identify the presence of symptoms or undesirable effects. This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
In the first week, all individuals of HomeRehab group will receive a training regarding the use of the monitoring equipment. A heart rate monitor with the heart rate zone individually calculated will be given to the participant at the first session of the face-to-face training to monitoring exercises at home. Furthermore, all participants of this group will use a step counter (pedometer) to stimulate the execution of the exercises as well as training diary to be fulfilled with information regarding the frequency of the exercises, the presence of symptoms during the exercise, the perceived exertion, and the number of daily steps. The monthly meetings will take place to the educational activity, and to verify if the exercises and fulfilment of the training diary are correct as well as to clarify any kind of the participant's doubts.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cardiac Disease
- Being tested
- Home-based Rehab, CentreRehab
- Keywords
- Rehabilitation, Coronary artery disease, Home-based, Randomized Controlled Trial, Protocol
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based RehabOther
This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
CentreRehabOther
This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week).
| Study group | Role | What they receive |
|---|---|---|
| Home-based Rehabilitation | Experimental | Home-based cardiac rehabilitation that includes the components of education and physical exercises mainly unsupervised and oriented by telephone. Receives: Other: Home-based Rehab |
| CentreRehabilitation | Active comparator | Traditional cardiac rehabilitation offered at the outpatient centre including components of education and physical exercises mainly supervised. Receives: Other: CentreRehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adherence on CR sessions
it will be analyzed by the percentage of participants which completed the minimum of 75% of the sessions
Measured: after 3 and 6 months of the intervention
Secondary outcomes (13)
Cost
total sum of the costs of each procedure applied to different groups considering the table of payments for procedures and services of the hospital.
Measured: after 3 and 6 months of the intervention
Usability
it will be analyzed using the System Usability Scale (SUS) after 3 months. The System Usability Scale (SUS) is a widely used self-administered instrument for the evaluation of usability of a wide range of products and user interfaces. The main value of the SUS is that it provides a single reference score for the participants' view of the usability of a product or service.
The SUS's scores vary in a value between zero and 100. A SUS's scores higher than 68 is considered above average, and any value below.
Measured: For TeleRehab group after 3 months of the intervention
Change in morbidity
It will be evaluated through a survey to identify the number of hospitalizations, complications, and presence of clinical events during the period of 3 and 6 months.
Measured: after 3 and 6 months of the intervention
Change in quality of life
Quality of life will be assessed by the Short-Form 36 (SF-36) questionnaire, a generic questionnaire, easy to administrate, that considers the individual perception about its own health status. It's composed by 36 items, divides in eight domains: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Data will be analyzed from the transformation of the answers in each domain in a scale from zero (0) to one hundred (100). This questionnaire won't have a cut point, and the analysis is made based in the hit score, resulting in a worse or better general health state.
Measured: At baseline, after 3 and 6 months
Change in scores of depression
The Patient Health Questionnaire-9 (PHQ-9) is a simple test, used for depression screening. The PHQ-9 is an instrument that has nine items, disposed in a scale of four points, from zero (not once) to three (almost every day), with a score that varies from zero to 27, to asses frequency of signs and symptoms of depression in the last two weeks. It is estimated, as a positive indicator of major depression, a value equal or higher than 10.
Measured: At baseline, after 3 and 6 months
Change in functional capacity
Functional Capacity will be analyzed using the Incremental Shuttle walk test, a walk test that evaluates functional capacity through the analysis of the walked distance at incremental shuttle walk test in meters.
Measured: At baseline, after 3 and 6 months
Change in level of physical activity
Score at the Duke Activity Status Index, a questionnaire developed to evaluate functional capacity mostly in patients with cardiovascular diseases. This questionnaire is composed of 12 items, which asses daily life activities such as personal hygiene, locomotion, domestic tasks, sexual function, and recreation, with the respective metabolic costs. Each item has a specific weight, based on its metabolic cots. The weight of the positive answers is summed up in order to obtain a total score that goes from zero to 58.2. The higher the punctuation, higher the functional capacity.
Measured: At baseline, after 3 and 6 months
Change in Blood pressure
Systolic and diastolic blood pressure measured at rest
Measured: At baseline, after 3 and 6 months
Change in Waist circumference
measurement of the waist circumference in centimeters.
Measured: At baseline, after 3 and 6 months
Change in fasting blood glucose
assessed through blood exams, as mg/dL
Measured: At baseline, after 3 and 6 months
Change in glycated hemoglobin
values, in %, will be assessed through blood tests.
Measured: At baseline, after 3 and 6 months
Change in total cholesterol
In mg/dL, will be assessed through blood tests.
Measured: At baseline, after 3 and 6 months
Change in knowledge about coronary artery disease
Will be analyzed using the CADE-Q SV. This questionnaire was designed to be a true/false/I don't know questionnaire, with 20 items (4 in each domain). Each correct answer equals to 1 point; therefore, the maximum score possible is 20 overall, 4 by domain, and 1 per item.
Measured: At baseline, after 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start26 Feb 2018
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Raquel Rodrigues Britto, Federal University of Minas Gerais
- Investigators
- Raquel R Britto, Post doc, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605992
- Sponsor's protocol ID
- FMMinasGerais
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2018
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA; European Association for Cardiovascular Prevention and Rehabilitation; American Association of Cardiovascular and Pulmonary Rehabilitation; Canadian Association of Cardiac Rehabilitation. Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the Canadian Association of Cardiac Rehabilitation. J Cardiopulm Rehabil Prev. 2012 Nov-Dec;32(6):327-50. doi: 10.1097/HCR.0b013e3182757050.
PubMed 23103476Varnfield M, Karunanithi M, Lee CK, Honeyman E, Arnold D, Ding H, Smith C, Walters DL. Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart. 2014 Nov;100(22):1770-9. doi: 10.1136/heartjnl-2014-305783. Epub 2014 Jun 27.
PubMed 24973083Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
PubMed 1494764Coutinho-Myrrha MA, Dias RC, Fernandes AA, Araujo CG, Hlatky MA, Pereira DG, Britto RR. Duke Activity Status Index for cardiovascular diseases: validation of the Portuguese translation. Arq Bras Cardiol. 2014 Apr;102(4):383-90. doi: 10.5935/abc.20140031. Epub 2014 Feb 17.
PubMed 24652056Santos IS, Tavares BF, Munhoz TN, Almeida LS, Silva NT, Tams BD, Patella AM, Matijasevich A. [Sensitivity and specificity of the Patient Health Questionnaire-9 (PHQ-9) among adults from the general population]. Cad Saude Publica. 2013 Aug;29(8):1533-43. doi: 10.1590/0102-311x00144612. Portuguese.
PubMed 24005919Ghisi GLM, Sandison N, Oh P. Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV. Patient Educ Couns. 2016 Mar;99(3):443-447. doi: 10.1016/j.pec.2015.11.002. Epub 2015 Nov 7.
PubMed 26610390Lima AP, Nascimento IO, Oliveira ACA, Martins THS, Pereira DAG, Britto RR. Home-Based Cardiac Rehabilitation in Brazil's Public Health Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 7;8(11):e13901. doi: 10.2196/13901.
PubMed 31697246
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance, Viability and Effectiveness of Home Based Cardiac Rehabilitation: a Randomised Trial
- ClinicalTrials.gov ID
- NCT03605992
- Acronym / sponsor ID
- FMMinasGerais
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cardiac Disease
- Keywords
- Rehabilitation, Coronary artery disease, Home-based, Randomized Controlled Trial, Protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- 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 proposal of this study is to verify if it is feasible and effective to offer a home based cardiac rehabilitation program, that includes the components of health education and physical exercises mostly unsupervised and oriented by telephone and to compare the treatment adherence, the effects in the functional capacity, and the control of coronary risk factors in relation to the traditional cardiac rehabilitation offered mostly supervised and center based.
Detailed description
This study will be developed with patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, provided they are considered of low and moderate risk for the practice of physical exercise of moderate intensity, according to the risk stratification proposed by the American Association of Cardiovascular and Pulmonary Rehabilitation. Volunteers will be recruited at the outpatient at the University Hospital's Cardiac Rehabilitation Centre. The study will be made in conformity with the CONSORT guidelines for non-pharmacological interventions. After being invited to the study, the volunteer whose accept the participation and sign the consent form will be randomized into two different groups: Traditional cardiac rehabilitation (mostly supervised) and Telerehabilitation (mostly unsupervised). The randomization will be made through the www.randomization.com website in blocks of four volunteers each. A blind researcher will evaluate participants before and after test, and will fulfill the database.
Intervention The parameters for the exercise prescription will be the same for both groups. Exercise sessions will be constituted of 5-10 minutes of warm up, 40 minutes of aerobic activity with heart rate between 60 and 80% of the heart rate reserve, and 5-10 minutes of cool down. The educational sessions will be given to both groups in six meetings with 40 minutes each, and items regarding the control of risk factors and treatment of cardiovascular diseases will be approached. After the period of 12 weeks of intervention all participants will be stimulated to continue to practice physical exercises at home or at the community, and they will be invited to a re-evaluation after three months.
Groups:
Traditional cardiac rehabilitation as control group (CentreRehab) The CentreRehab group will be made supervised exercises and health educational activities, personally at cardiac rehabilitation centre. This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week). The participants of this group will be oriented to fulfill a training diary with information regarding the frequency of the exercises, the presence of symptoms, and the use of the scale of perceived exertion during exercises at home.
Home-based cardiac rehabilitation (HomeRehab) The participants of the HomeRehab group will make the exercise mostly at home. There will be weekly phone calls, in person educational sessions, and monthly meetings to check the execution of the previous stage, solve doubts, or identify the presence of symptoms or undesirable effects. This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
In the first week, all individuals of HomeRehab group will receive a training regarding the use of the monitoring equipment. A heart rate monitor with the heart rate zone individually calculated will be given to the participant at the first session of the face-to-face training to monitoring exercises at home. Furthermore, all participants of this group will use a step counter (pedometer) to stimulate the execution of the exercises as well as training diary to be fulfilled with information regarding the frequency of the exercises, the presence of symptoms during the exercise, the perceived exertion, and the number of daily steps. The monthly meetings will take place to the educational activity, and to verify if the exercises and fulfilment of the training diary are correct as well as to clarify any kind of the participant's doubts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Rehabilitation | Experimental | Other: Home-based RehabHome-based cardiac rehabilitation that includes the components of education and physical exercises mainly unsupervised and oriented by telephone. |
| CentreRehabilitation | Active comparator | Other: CentreRehabTraditional cardiac rehabilitation offered at the outpatient centre including components of education and physical exercises mainly supervised. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with coronary disease submitted to angioplasty or myocardial revascularization surgery, or that had a heart attack, provided they are considered of a low and moderate risk for the practice of physical exercise of moderate intensity according to the stratification for the risk of events during a cardiovascular rehabilitation program
- Clinical stability, according with the medical evaluation;
- Residents of the Belo Horizonte's metropolitan region.
Key exclusion criteria (6 listed)
- Recent cardiac event or clinical decompensation (<1month);
- Presence of peripheral arterial occlusive disease with limitation degree that prevents the test of maximum exercise (emergence of claudication before the maximum cardiorespiratory fatigue);
- Presence of chronic pulmonary disease (i.e. Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, and pulmonary arterial hypertension of pre capillary etiology);
- History of ventricular fibrillation or sustained ventricular tachycardia in the last year;
- Presence of high risk criteria during the ergometric test;
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 |
|---|---|---|
| Home-based RehabThis intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week). | Other | Home-based Rehabilitation |
| CentreRehabThis intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week). | Other | CentreRehabilitation |
Primary outcome
Change in adherence on CR sessions
Time frame: after 3 and 6 months of the intervention
it will be analyzed by the percentage of participants which completed the minimum of 75% of the sessions
13 secondary outcomes
Cost
Time frame: after 3 and 6 months of the intervention
Usability
Time frame: For TeleRehab group after 3 months of the intervention
Change in morbidity
Time frame: after 3 and 6 months of the intervention
Change in quality of life
Time frame: At baseline, after 3 and 6 months
Change in scores of depression
Time frame: At baseline, after 3 and 6 months
Change in functional capacity
Time frame: At baseline, after 3 and 6 months
Change in level of physical activity
Time frame: At baseline, after 3 and 6 months
Change in Blood pressure
Time frame: At baseline, after 3 and 6 months
Change in Waist circumference
Time frame: At baseline, after 3 and 6 months
Change in fasting blood glucose
Time frame: At baseline, after 3 and 6 months
Change in glycated hemoglobin
Time frame: At baseline, after 3 and 6 months
Change in total cholesterol
Time frame: At baseline, after 3 and 6 months
Change in knowledge about coronary artery disease
Time frame: At baseline, after 3 and 6 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 24 Jul 2020.
- Results publication: PubMed 23103476Mezzani A, Hamm LF, Jones AM, McBride PE, Moholdt T, Stone JA, Urhausen A, Williams MA; European Association for Cardiovascular Prevention and Rehabilitation; American Association of Cardiovascular and Pulmonary Rehabilitation; Canadian Association of Cardiac Rehabilitation. Aerobic exercise intensity assessment and prescription in cardiac rehabilitation: a joint position statement of the European Association for Cardiovascular Prevention and Rehabilitation, the American Association of Cardiovascular and Pulmonary Rehabilitation, and the Canadian Association of Cardiac Rehabilitation. J Cardiopulm Rehabil Prev. 2012 Nov-Dec;32(6):327-50. doi: 10.1097/HCR.0b013e3182757050.
- Results publication: PubMed 24973083Varnfield M, Karunanithi M, Lee CK, Honeyman E, Arnold D, Ding H, Smith C, Walters DL. Smartphone-based home care model improved use of cardiac rehabilitation in postmyocardial infarction patients: results from a randomised controlled trial. Heart. 2014 Nov;100(22):1770-9. doi: 10.1136/heartjnl-2014-305783. Epub 2014 Jun 27.
- Results publication: PubMed 1494764Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
- Results publication: PubMed 24652056Coutinho-Myrrha MA, Dias RC, Fernandes AA, Araujo CG, Hlatky MA, Pereira DG, Britto RR. Duke Activity Status Index for cardiovascular diseases: validation of the Portuguese translation. Arq Bras Cardiol. 2014 Apr;102(4):383-90. doi: 10.5935/abc.20140031. Epub 2014 Feb 17.
- Results publication: PubMed 24005919Santos IS, Tavares BF, Munhoz TN, Almeida LS, Silva NT, Tams BD, Patella AM, Matijasevich A. [Sensitivity and specificity of the Patient Health Questionnaire-9 (PHQ-9) among adults from the general population]. Cad Saude Publica. 2013 Aug;29(8):1533-43. doi: 10.1590/0102-311x00144612. Portuguese.
- Results publication: PubMed 26610390Ghisi GLM, Sandison N, Oh P. Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV. Patient Educ Couns. 2016 Mar;99(3):443-447. doi: 10.1016/j.pec.2015.11.002. Epub 2015 Nov 7.
- Derived from this study: PubMed 31697246Lima AP, Nascimento IO, Oliveira ACA, Martins THS, Pereira DAG, Britto RR. Home-Based Cardiac Rehabilitation in Brazil's Public Health Care: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Nov 7;8(11):e13901. doi: 10.2196/13901.
- American Association for Cardiovascular and Pulmonary Rehabilitation. Guidelines for Cardiac Rehabilitation and Secondary Prevention Programs. 5th ed. Champaign.Human Kinetics Publishers; 2013.Link provided by the sponsor.
- CICONELLI, R.M. et al. Brazilian Portuguese version of the SF-36. A reliable and valid quality of life outcome measure. Rev. Bras. Reumatol., v.39, n.3, p.143-50, 1999.Link provided by the sponsor.
- 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.
Raquel R Britto, Post doc principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Rehab and CentreRehab in people with Cardiovascular Diseases and Coronary Disease, run by Federal University of Minas Gerais 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 6 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 24 Jul 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 adherence on CR sessions (time frame: after 3 and 6 months of the intervention). 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 NCT03605992, which also lists 7 linked publications.
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 24 Jul 2020.