- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02721758
Understanding and Promoting Health Behaviour Change Amid Transition to Cardiac Rehabilitation (UPBeAT-CR)
Design and Evaluation of a Brief Motivational Intervention to Promote Enrolment in Outpatient Cardiac Rehabilitation
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Alberta
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Calgary, Alberta, Canadá, T2N1N4
- Department of Psychology, University of Calgary
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Referred to and eligible for outpatient, exercise-based cardiac rehabilitation; confirmed acute coronary syndrome; English-speaking; able to complete study prior to first scheduled cardiac rehabilitation appointment
Exclusion Criteria:
- Cognitive or hearing impairment that would interfere with study participation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Brief Motivational Intervention
Single, 60-minute, manualized behavioural intervention designed to support cardiac rehabilitation enrollment, informed by principles of motivational interviewing
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Sin intervención: Usual Care
Standard encouragement to enroll in cardiac rehabilitation, and meeting with a researcher to complete study questionnaires
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Intention to Attend Cardiac Rehabilitation Scale (adapted from Blanchard et al., 2002)
Periodo de tiempo: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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Intention to attend cardiac rehabilitation will be assessed using the average of two self-report items: (1) "My goal is to attend ___ exercise classes at cardiac rehabilitation" with responses ranging from 1 (no exercise classes) to 7 (some exercise classes) and (2) "I intend to attend scheduled classes during cardiac rehabilitation" with responses ranging from 1 (strongly disagree) to 7 (strongly agree). Blanchard, C. M., Courneya, K. S., Rodgers, W. M., Daub, B., & Knapik, G. (2002). Determinants of exercise intention and behavior during and after phase 2 cardiac rehabilitation: An application of the theory of planned behavior. Rehabilitation Psychology, 47(3), 308-323. |
At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Cardiac Rehabilitation Enrollment (attendance at ≥1 appointment; chart review)
Periodo de tiempo: 60 days after initial referral to cardiac rehabilitation program
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Participation in cardiac rehabilitation will be confirmed by chart review 60 days after referral.
Non-enrollment will be defined as (a) explicitly declining interest in CR participation, (b) not attending the initial scheduled exercise appointment within 60 days of referral, or (c) inability to be contacted by program staff within 60 days of referral to cardiac rehabilitation.
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60 days after initial referral to cardiac rehabilitation program
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Beliefs About Cardiac Rehabilitation Scale (BACR; Cooper et al., 2007)
Periodo de tiempo: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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The BACR is a 13-item questionnaire that evaluates patients' beliefs regarding CR. Items are rated on a 5-point Likert-type scale, ranging from "strongly disagree" to "strongly agree." Items are summed to provide a score on each of four subscales: perceived necessity, concerns about exercise, practical barriers, and perceived suitability. Cooper, A. F., Weinman, J., Hankins, M., Jackson, G., & Horne, R. (2007). Assessing patients' beliefs about cardiac rehabilitation as a basis for predicting attendance after acute myocardial infarction. Heart (British Cardiac Society), 93(1), 53-8. doi:10.1136/hrt.2005.081299 |
At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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Multidimensional Self-Efficacy for Exercise Scale (Rodgers et al., 2008)
Periodo de tiempo: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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The MSES is a 9-item questionnaire that evaluates exercise self-efficacy in three domains: task (e.g., ability to follow directions to complete exercise), coping (e.g., ability to exercise when feeling discomfort from exercise), and scheduling (e.g. ability to fit exercise into daily routine). Items are rated from 0 (not at all confident) to 100 (completely confident), and averaged in each domain. Rodgers, W. M., Wilson, P. M., Hall, C. R., Fraser, S. N., & Murray, T. C. (2008). Evidence for a multidimensional self-efficacy for exercise scale. Research Quarterly for Exercise and Sport, 79(2), 222-34. |
At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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Cardiac Rehabilitation Barriers Scale (CRBS; Shanmugasegaram et al., 2012)
Periodo de tiempo: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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The CRBS is a 21-item questionnaire designed to assess perceptions of patient, provider, and health system barriers to CR participation. Items are rated on 5-point Likert-type scales ranging from "strongly disagree" to "strongly agree," and are averaged to provide a total score, with higher scores indicating greater perceived barriers. Totals are also calculated for four subscales: perceived need/healthcare factors, logistical factors, work/time conflicts, and comorbidities/functional status. Shanmugasegaram, S., Gagliese, L., Oh, P., Stewart, D. E., Brister, S. J., Chan, V., & Grace, S. L. (2012). Psychometric validation of the Cardiac Rehabilitation Barriers Scale. Clinical Rehabilitation, 26(2), 152-64. doi:10.1177/0269215511410579 |
At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
ENRICHD Social Support Instrument (ESSI; Mitchell et al., 2003)
Periodo de tiempo: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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The ESSI is a 7-item questionnaire designed to assess social support in patients post-myocardial infarction. Items are rated from 1 (none of the time) to 5 (all of the time), and are summed to provide a total score, with higher scores indicating more social support. Mitchell, P. H., Powell, L., Blumenthal, J., Norten, J., Ironson, G., Pitula, C. R., ... & Berkman, L. F. (2003). A short social support measure for patients recovering from myocardial infarction: the ENRICHD Social Support Inventory. Journal of Cardiopulmonary Rehabilitation and Prevention, 23(6), 398-403. |
At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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Brief Illness Perceptions Questionnaire (BIPQ; Broadbent et al., 2006)
Periodo de tiempo: At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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The BIPQ is an 8-item questionnaire that assesses cognitive and emotional representations of illness. It evaluates perceived consequences, timelines, personal/treatment control, symptoms, concern, understanding, and emotional consequences associated with the illness. Items are summed to provide a total score, with higher scores indicating greater perceived threat of the illness. Broadbent, E., Petrie, K. J., Main, J., & Weinman, J. (2006). The brief illness perception questionnaire. Journal of Psychosomatic Research, 60(6), 631-7. doi:10.1016/j.jpsychores.2005.10.020 |
At least 1 day after receiving MI or UC but prior to enrollment in cardiac rehabilitation (average 7 days)
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Cardiac rehabilitation adherence (# of cardiac rehabilitation sessions attended; chart review)
Periodo de tiempo: Following a 12-week cardiac rehabilitation program
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Number of cardiac rehabilitation sessions attended (out of a total possible 24 scheduled sessions)
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Following a 12-week cardiac rehabilitation program
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- REB14-1213
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