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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Institut Català de la Salut | OTHER |
| Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational interview | Experimental | Motivation Interview program with standard care |
|
| Standard care group | Active Comparator | Standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational interview | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical functional capacity | Improvement in aerobic capacity and resistance, measured by a physical effort test | 1st month |
| Physical functional capacity | Improvement in aerobic capacity and resistance, measured by a physical effort test | 6th month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1st month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis González de Paz, PhD | Contact | 0034 932275683 | lgonzale@clinic.cat | |
| RocÃo RodrÃguez Romero, RN | Contact | 0034932279800 | 381179 | rorodri@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Luis González de Paz, PhD | Consorci d'Atenció Primà ria de Salut Barcelona Esquerra (CAPSBE) | Principal Investigator |
| RocÃo RodrÃguez Romero, RN | Consorci d'Atenció Primà ria de Salut Barcelona Esquerra (CAPSBE) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Atenció Primà ria de Les Corts | Recruiting | Barcelona | 08028 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20300001 | Background | 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. | |
| 30782007 |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Institut d'Investigacions Biomèdiques August Pi i Sunyer |
| OTHER |
| Hospital Clinic of Barcelona | OTHER |
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|
| Active Comparator: Standard care group | Behavioral | 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). |
|
| 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. | 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. | 6th month |
| Psychological status | Measured with the Psychological General Well-Being Index (PGWBI) | 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). | 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). | 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). | 3rd month |
| Carles Falces Salvador, PhD | Cardiovascular Institute. Hospital ClÃnic. University of Barcelona, Barcelona, Spain. | Study Chair |
| CAP Compte Borrell | Not yet recruiting | Barcelona | 08029 | Spain |
|
| Centre Atenció Primà ria Montengre | Recruiting | Barcelona | 08029 | Spain |
|
| Centre Atenció Primà ria Casanova | Recruiting | Barcelona | 08036 | Spain |
|
| Background |
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| 35513777 | Derived | Rodriguez-Romero R, Falces C, Kostov B, Garcia-Planas N, Blat-Guimera E, Alvira-Balada MC, Lopez-Poyato M, Benito-Serrano ML, Vidiella-Pinol I, Zamora-Sanchez JJ, Benet M, Garnacho-Castano MV, Santos-Ruiz S, Santesmases-Masana R, Roura-Rovira S, Benavent-Areu J, Siso-Almirall A, Gonzalez-de Paz L. A motivational interview program for cardiac rehabilitation after acute myocardial infarction: study protocol of a randomized controlled trial in primary healthcare. BMC Prim Care. 2022 May 6;23(1):106. doi: 10.1186/s12875-022-01721-y. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |