Myocardial Infarction, AcuteNCT05285969
Cardiac Rehabilitation With Motivational Interview for Acute Myocardial Infarction
A study testing Motivational interview in people with Myocardial Infarction, Acute, run by Consorci d'Atenció Primària de Salut de l'Eixample at 4 sites in Spain.
Trial summary
Introduction: Secondary prevention after acute myocardial infarction may include cardiac rehabilitation and lifestyle changes. Cardiac rehabilitation has mainly taken place in hospitals without coordination with primary healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Acute
- What is being tested?
- Motivational interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 4 sitesSpain
- Study dates
- 1 Apr 2022to 1 Dec 2025
- 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
- Age >18 years.
- Hospital admission for acute coronary syndrome (diagnostic codes ICD-10: I20-I22).
- Post unscheduled cardiac revascularization surgery (procedure code ICD-10: 021x).
- Discharge to home with the area of the 7 PHCs.
- Indication of RC indication.
- Voluntary participation.
Who cannot join
- Acute aortic disease,
- Severe pulmonary hypertension.
- Uncontrolled arrhythmias.
- Decompensated Heart Failure or significant valvular or congenital heart disease.
- Intervention in heart valves and/or interventricular septum.
- Diseases that prevent exercise.
Show all 12Show fewer
- Osteoarticular disease that severely limits exercise.
- Severe mental disorder.
- Any severe psychiatric disorders.
- Cognitive disability.
- Verbal communication problems.
- Participation in hospital Cardiac Rehabilitation.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Centre Atenció Primària de Les Corts
Barcelona, 08028
Luis González de Paz, PhD
- Not yet recruiting
CAP Compte Borrell
Barcelona, 08029
Noemí García-Planes, R.N.
- Recruiting
Centre Atenció Primària Montengre
Barcelona, 08029
Juan J. Zamora, RN
- Recruiting
Centre Atenció Primària Casanova
Barcelona, 08036
Rocio Rodríguez Romero, BSN
About this study
Official title: Motivational Interview for Cardiac Rehabilitation in Acute Myocardial Infarction: A Randomized Controlled Trial in the Primary Healthcare Area.
Introduction: Secondary prevention after acute myocardial infarction may include cardiac rehabilitation and lifestyle changes. Cardiac rehabilitation has mainly taken place in hospitals without coordination with primary healthcare. Motivational interviews have been shown to be effective as a means for change in patients after acute myocardial infarction. The objective of this study is to evaluate the effectiveness of a cardiac rehabilitation program with motivational interviews in patients discharged from hospital after acute myocardial infarction.
Methods: Randomized clinical non-pharmacological trial. A minimum sample of 284 participants requiring cardiac rehabilitation after acute myocardial infarction in six primary healthcare centers. Participants will be randomized to cardiac rehabilitation with motivational interviews or normal standard of care. All secondary results will be evaluated at 1,3 and 6 months.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- Motivational interview, Active Comparator: Standard care group
- Keywords
- Myocardial Infarction, Cardiac Rehabilitation, Rehabilitation Nursing, Primary Health Care, Motivational Interviewing
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewBehavioural
The new CR program with MI will be structured in 4 sessions and an optional fifth during the six months after discharge. The methodology of the MI sessions will follow the four phases logical sequence of MI proposed by Rollnick and Millner. 1) engage in a collaborative relationship, 2) focus on a particular change, 3) evoke intrinsic motivations for change, and 4) plan an immediate step for change
Active Comparator: Standard care groupBehavioural
All patients in the control group will receive a kit with informative material with the actions and procedures to follow (diet, physical activity, smoking cessation, and other recommendations about secondary prevention).
| Study group | Role | What they receive |
|---|---|---|
| Motivational interview | Experimental | Motivation Interview program with standard care Receives: Behavioral: Motivational interview |
| Standard care group | Active comparator | Standard care Receives: Behavioral: Active Comparator: Standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functional capacity
Improvement in aerobic capacity and resistance, measured by a physical effort test
Measured: 1st month
Physical functional capacity
Improvement in aerobic capacity and resistance, measured by a physical effort test
Measured: 6th month
Secondary outcomes (7)
Effectiveness of secondary prevention
Effectiveness of secondary prevention will be considered (Satisfied / no satisfied) with next conditions (all together):
Blood pressure values <140/90mmHg, plasma cholesterol c-LDL<70mg/dL, plasma glycosylated hemoglobin <7%. Absolute cessation or no initiation of smoking Body Mass Index in the range of 18.5-25kg/m^2.
Measured: 1st month
Effectiveness of secondary prevention
Effectiveness of secondary prevention will be considered (Satisfied / no satisfied) with next conditions (all together):
Blood pressure values <140/90mmHg, plasma cholesterol c-LDL<70mg/dL, plasma glycosylated hemoglobin <7%. Absolute cessation or no initiation of smoking Body Mass Index in the range of 18.5-25kg/m^2.
Measured: 3rd month
Effectiveness of secondary prevention
Effectiveness of secondary prevention will be considered (Satisfied / no satisfied) with next conditions (all together):
Blood pressure values <140/90mmHg, plasma cholesterol c-LDL<70mg/dL, plasma glycosylated hemoglobin <7%. Absolute cessation or no initiation of smoking Body Mass Index in the range of 18.5-25kg/m^2.
Measured: 6th month
Psychological status
Measured with the Psychological General Well-Being Index (PGWBI)
Measured: 6th month
Perceived quality of life
Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).
Measured: 1st month
Perceived quality of life
Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).
Measured: 2nd month
Perceived quality of life
Physical and mental summaries of perceived quality of life measured with the generic quality of life Short Form questionnaire (SF-12).
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction, AcuteStudies 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
- None (open label)
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'Eixample
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Institut Català de la Salut, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Luis Gonzalez de Paz, Consorci d'Atenció Primària de Salut de l'Eixample
- Investigators
- Luis González de Paz, PhD, Principal investigator, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)Rocío Rodríguez Romero, RN, Study chair, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)Carles Falces Salvador, PhD, Study chair, Cardiovascular Institute. Hospital Clínic. University of Barcelona, Barcelona, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285969
- Sponsor's protocol ID
- HCB/2019/0727
- Status last verified
- Mar 2023
- First submitted
- 28 Feb 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjarnason-Wehrens B, McGee H, Zwisler AD, Piepoli MF, Benzer W, Schmid JP, Dendale P, Pogosova NG, Zdrenghea D, Niebauer J, Mendes M; Cardiac Rehabilitation Section European Association of Cardiovascular Prevention and Rehabilitation. Cardiac rehabilitation in Europe: results from the European Cardiac Rehabilitation Inventory Survey. Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):410-8. doi: 10.1097/HJR.0b013e328334f42d.
PubMed 20300001Abreu A, Pesah E, Supervia M, Turk-Adawi K, Bjarnason-Wehrens B, Lopez-Jimenez F, Ambrosetti M, Andersen K, Giga V, Vulic D, Vataman E, Gaita D, Cliff J, Kouidi E, Yagci I, Simon A, Hautala A, Tamuleviciute-Prasciene E, Kemps H, Eysymontt Z, Farsky S, Hayward J, Prescott E, Dawkes S, Pavy B, Kiessling A, Sovova E, Grace SL. Cardiac rehabilitation availability and delivery in Europe: How does it differ by region and compare with other high-income countries?: Endorsed by the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2019 Jul;26(11):1131-1146. doi: 10.1177/2047487319827453. Epub 2019 Feb 20.
PubMed 30782007Martín R. Efectividad de la rehabilitación cardíaca en un grupo de pacientes de alto riesgo. Rev Enferm Cardiol. 2018;25(75):34-39.
Shields GE, Wells A, Doherty P, Heagerty A, Buck D, Davies LM. Cost-effectiveness of cardiac rehabilitation: a systematic review. Heart. 2018 Sep;104(17):1403-1410. doi: 10.1136/heartjnl-2017-312809. Epub 2018 Apr 13.
PubMed 29654096Piepoli MF, Corra U, Adamopoulos S, Benzer W, Bjarnason-Wehrens B, Cupples M, Dendale P, Doherty P, Gaita D, Hofer S, McGee H, Mendes M, Niebauer J, Pogosova N, Garcia-Porrero E, Rauch B, Schmid JP, Giannuzzi P. Secondary prevention in the clinical management of patients with cardiovascular diseases. Core components, standards and outcome measures for referral and delivery: a policy statement from the cardiac rehabilitation section of the European Association for Cardiovascular Prevention & Rehabilitation. Endorsed by the Committee for Practice Guidelines of the European Society of Cardiology. Eur J Prev Cardiol. 2014 Jun;21(6):664-81. doi: 10.1177/2047487312449597. Epub 2012 Jun 20.
PubMed 22718797Verbo E. Protocolo de rehabilitación cardiaca en pacientes con insuficiencia cardiaca (Tesis). Universidad CEU-San Pablo. 2012.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819Kotseva K, Wood D, De Bacquer D, De Backer G, Ryden L, Jennings C, Gyberg V, Amouyel P, Bruthans J, Castro Conde A, Cifkova R, Deckers JW, De Sutter J, Dilic M, Dolzhenko M, Erglis A, Fras Z, Gaita D, Gotcheva N, Goudevenos J, Heuschmann P, Laucevicius A, Lehto S, Lovic D, Milicic D, Moore D, Nicolaides E, Oganov R, Pajak A, Pogosova N, Reiner Z, Stagmo M, Stork S, Tokgozoglu L, Vulic D; EUROASPIRE Investigators. EUROASPIRE IV: A European Society of Cardiology survey on the lifestyle, risk factor and therapeutic management of coronary patients from 24 European countries. Eur J Prev Cardiol. 2016 Apr;23(6):636-48. doi: 10.1177/2047487315569401. Epub 2015 Feb 16.
PubMed 25687109Haykowsky M, Scott J, Esch B, Schopflocher D, Myers J, Paterson I, Warburton D, Jones L, Clark AM. A meta-analysis of the effects of exercise training on left ventricular remodeling following myocardial infarction: start early and go longer for greatest exercise benefits on remodeling. Trials. 2011 Apr 4;12:92. doi: 10.1186/1745-6215-12-92.
PubMed 21463531Bohplian S, Bronas UG. Motivational Strategies and Concepts to Increase Participation and Adherence in Cardiac Rehabilitation: AN INTEGRATIVE REVIEW. J Cardiopulm Rehabil Prev. 2022 Mar 1;42(2):75-83. doi: 10.1097/HCR.0000000000000639.
PubMed 34753873Sociedad Española de Cardiología. Registro Nacional de Unidades de Rehabilitación Cardíaca. R- EUReCa. Available from: https://secardiologia.es/riesgo/cientifico/6415-registro-nacional-de-unidades-de-rehabilitacion- cardiaca-r-eureka (accessed 30 Jan 2019).
Rodrigo-Banos V, Moral-Pairada MD, Gonzalez-de Paz L. A Comprehensive Assessment of Informal Caregivers of Patients in a Primary Healthcare Home-Care Program. Int J Environ Res Public Health. 2021 Nov 4;18(21):11588. doi: 10.3390/ijerph182111588.
PubMed 34770102Gene-Badia J, Ascaso C, Escaramis-Babiano G, Sampietro-Colom L, Catalan-Ramos A, Sans-Corrales M, Pujol-Ribera E. Personalised care, access, quality and team coordination are the main dimensions of family medicine output. Fam Pract. 2007 Feb;24(1):41-7. doi: 10.1093/fampra/cml056. Epub 2006 Nov 1.
PubMed 17079249Pujol Ribera E, Gene Badia J, Sans Corrales M, Sampietro-Colom L, Pasarin Rua MI, Iglesias-Perez B, Casajuana-Brunet J, Escaramis-Babiano G. [Primary health care product defined by health professionals and users]. Gac Sanit. 2006 May-Jun;20(3):209-19. doi: 10.1157/13088852. Spanish.
PubMed 16756859Palomo L, Gene-Badia J, Rodriguez-Sendin JJ. [The reform of primary care, between the last refuge of adventure and innovation. SESPAS report 2012]. Gac Sanit. 2012 Mar;26 Suppl 1:14-9. doi: 10.1016/j.gaceta.2011.06.010. Epub 2011 Oct 11. Spanish.
PubMed 21996448
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interview for Cardiac Rehabilitation in Acute Myocardial Infarction: A Randomized Controlled Trial in the Primary Healthcare Area.
- ClinicalTrials.gov ID
- NCT05285969
- Acronym / sponsor ID
- HCB/2019/0727
- Conditions
- Myocardial Infarction, Acute
- Keywords
- Myocardial Infarction, Cardiac Rehabilitation, Rehabilitation Nursing, Primary Health Care, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'EixampleUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Institut Català de la Salut, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Hospital Clinic of Barcelona
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Mar 2022 (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.
Introduction: Secondary prevention after acute myocardial infarction may include cardiac rehabilitation and lifestyle changes. Cardiac rehabilitation has mainly taken place in hospitals without coordination with primary healthcare. Motivational interviews have been shown to be effective as a means for change in patients after acute myocardial infarction. The objective of this study is to evaluate the effectiveness of a cardiac rehabilitation program with motivational interviews in patients discharged from hospital after acute myocardial infarction.
Methods: Randomized clinical non-pharmacological trial. A minimum sample of 284 participants requiring cardiac rehabilitation after acute myocardial infarction in six primary healthcare centers. Participants will be randomized to cardiac rehabilitation with motivational interviews or normal standard of care. All secondary results will be evaluated at 1,3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interview | Experimental | Behavioral: Motivational interviewMotivation Interview program with standard care |
| Standard care group | Active comparator | Behavioral: Active Comparator: Standard care groupStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years.
- Hospital admission for acute coronary syndrome (diagnostic codes ICD-10: I20-I22).
- Post unscheduled cardiac revascularization surgery (procedure code ICD-10: 021x).
- Discharge to home with the area of the 7 PHCs.
- Indication of RC indication.
Key exclusion criteria (12 listed)
- Acute aortic disease,
- Severe pulmonary hypertension.
- Uncontrolled arrhythmias.
- Decompensated Heart Failure or significant valvular or congenital heart disease.
- Intervention in heart valves and/or interventricular septum.
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 |
|---|---|---|
| Motivational interviewThe new CR program with MI will be structured in 4 sessions and an optional fifth during the six months after discharge. The methodology of the MI sessions will follow the four phases logical sequence of MI proposed by Rollnick and Millner. 1) engage in a collaborative relationship, 2) focus on a particular change, 3) evoke intrinsic motivations for change, and 4) plan an immediate step for change | Behavioural | Motivational interview |
| Active Comparator: Standard care groupAll patients in the control group will receive a kit with informative material with the actions and procedures to follow (diet, physical activity, smoking cessation, and other recommendations about secondary prevention). | Behavioural | Standard care group |
Primary outcome
Physical functional capacity
Time frame: 1st month
Improvement in aerobic capacity and resistance, measured by a physical effort test
Physical functional capacity
Time frame: 6th month
Improvement in aerobic capacity and resistance, measured by a physical effort test
7 secondary outcomes
Effectiveness of secondary prevention
Time frame: 1st month
Effectiveness of secondary prevention
Time frame: 3rd month
Effectiveness of secondary prevention
Time frame: 6th month
Psychological status
Time frame: 6th month
Perceived quality of life
Time frame: 1st month
Perceived quality of life
Time frame: 2nd month
Perceived quality of life
Time frame: 3rd month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 20300001Bjarnason-Wehrens B, McGee H, Zwisler AD, Piepoli MF, Benzer W, Schmid JP, Dendale P, Pogosova NG, Zdrenghea D, Niebauer J, Mendes M; Cardiac Rehabilitation Section European Association of Cardiovascular Prevention and Rehabilitation. Cardiac rehabilitation in Europe: results from the European Cardiac Rehabilitation Inventory Survey. Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):410-8. doi: 10.1097/HJR.0b013e328334f42d.
- Background: PubMed 30782007Abreu A, Pesah E, Supervia M, Turk-Adawi K, Bjarnason-Wehrens B, Lopez-Jimenez F, Ambrosetti M, Andersen K, Giga V, Vulic D, Vataman E, Gaita D, Cliff J, Kouidi E, Yagci I, Simon A, Hautala A, Tamuleviciute-Prasciene E, Kemps H, Eysymontt Z, Farsky S, Hayward J, Prescott E, Dawkes S, Pavy B, Kiessling A, Sovova E, Grace SL. Cardiac rehabilitation availability and delivery in Europe: How does it differ by region and compare with other high-income countries?: Endorsed by the European Association of Preventive Cardiology. Eur J Prev Cardiol. 2019 Jul;26(11):1131-1146. doi: 10.1177/2047487319827453. Epub 2019 Feb 20.
- BackgroundMartín R. Efectividad de la rehabilitación cardíaca en un grupo de pacientes de alto riesgo. Rev Enferm Cardiol. 2018;25(75):34-39.
- Background: PubMed 29654096Shields GE, Wells A, Doherty P, Heagerty A, Buck D, Davies LM. Cost-effectiveness of cardiac rehabilitation: a systematic review. Heart. 2018 Sep;104(17):1403-1410. doi: 10.1136/heartjnl-2017-312809. Epub 2018 Apr 13.
- Background: PubMed 22718797Piepoli MF, Corra U, Adamopoulos S, Benzer W, Bjarnason-Wehrens B, Cupples M, Dendale P, Doherty P, Gaita D, Hofer S, McGee H, Mendes M, Niebauer J, Pogosova N, Garcia-Porrero E, Rauch B, Schmid JP, Giannuzzi P. Secondary prevention in the clinical management of patients with cardiovascular diseases. Core components, standards and outcome measures for referral and delivery: a policy statement from the cardiac rehabilitation section of the European Association for Cardiovascular Prevention & Rehabilitation. Endorsed by the Committee for Practice Guidelines of the European Society of Cardiology. Eur J Prev Cardiol. 2014 Jun;21(6):664-81. doi: 10.1177/2047487312449597. Epub 2012 Jun 20.
- BackgroundVerbo E. Protocolo de rehabilitación cardiaca en pacientes con insuficiencia cardiaca (Tesis). Universidad CEU-San Pablo. 2012.
- Background: PubMed 27206819Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
- Background: PubMed 25687109Kotseva K, Wood D, De Bacquer D, De Backer G, Ryden L, Jennings C, Gyberg V, Amouyel P, Bruthans J, Castro Conde A, Cifkova R, Deckers JW, De Sutter J, Dilic M, Dolzhenko M, Erglis A, Fras Z, Gaita D, Gotcheva N, Goudevenos J, Heuschmann P, Laucevicius A, Lehto S, Lovic D, Milicic D, Moore D, Nicolaides E, Oganov R, Pajak A, Pogosova N, Reiner Z, Stagmo M, Stork S, Tokgozoglu L, Vulic D; EUROASPIRE Investigators. EUROASPIRE IV: A European Society of Cardiology survey on the lifestyle, risk factor and therapeutic management of coronary patients from 24 European countries. Eur J Prev Cardiol. 2016 Apr;23(6):636-48. doi: 10.1177/2047487315569401. Epub 2015 Feb 16.
- Background: PubMed 21463531Haykowsky M, Scott J, Esch B, Schopflocher D, Myers J, Paterson I, Warburton D, Jones L, Clark AM. A meta-analysis of the effects of exercise training on left ventricular remodeling following myocardial infarction: start early and go longer for greatest exercise benefits on remodeling. Trials. 2011 Apr 4;12:92. doi: 10.1186/1745-6215-12-92.
- Background: PubMed 34753873Bohplian S, Bronas UG. Motivational Strategies and Concepts to Increase Participation and Adherence in Cardiac Rehabilitation: AN INTEGRATIVE REVIEW. J Cardiopulm Rehabil Prev. 2022 Mar 1;42(2):75-83. doi: 10.1097/HCR.0000000000000639.
- BackgroundSociedad Española de Cardiología. Registro Nacional de Unidades de Rehabilitación Cardíaca. R- EUReCa. Available from: https://secardiologia.es/riesgo/cientifico/6415-registro-nacional-de-unidades-de-rehabilitacion- cardiaca-r-eureka (accessed 30 Jan 2019).
- Background: PubMed 34770102Rodrigo-Banos V, Moral-Pairada MD, Gonzalez-de Paz L. A Comprehensive Assessment of Informal Caregivers of Patients in a Primary Healthcare Home-Care Program. Int J Environ Res Public Health. 2021 Nov 4;18(21):11588. doi: 10.3390/ijerph182111588.
- 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.
Luis González de Paz, PhD principal investigator
Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
Rocío Rodríguez Romero, RN study chair
Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
Carles Falces Salvador, PhD study chair
Cardiovascular Institute. Hospital Clínic. University of Barcelona, Barcelona, Spain.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interview in people with Myocardial Infarction, Acute, run by Consorci d'Atenció Primària de Salut de l'Eixample at 4 sites in Spain.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis González de Paz, PhD (0034 932275683, lgonzale@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functional capacity (time frame: 1st month). The study lists 2 primary outcomes in all. 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 NCT05285969, which also lists 33 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 29 Mar 2023.