- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02888769
Cardiovascular Health and Texting Messaging (CHAT) Study
Effectiveness of Text Messaging on Risk Factors Control and Medication Adherence Among Coronary Heart Disease Patients Without Diabetes in Cardiovascular Health and Texting Messaging (CHAT) Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Objective: This study aims to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention, including lifestyles modification, medication adherence improvement and risk factors control among CHD patients without diabetes. We hypothesized that an intervention using mobile phone text based education and reminder can improve risk factors control and medication adherence for CHD patients.
Study design: The study is a two-arm, parallel, randomized clinical trial. Patients will be eligible if they have documented CHD defined as having history of myocardial infarction and PCI but without diabetes mellitus, have the capability of reading and sending short message, and are able to provide informed consent. Patients who do not have an active mobile phone will be excluded. The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly. The intervention group will receive intervention of pre-designed text messages in addition to usual care, while the control group will receive usual care. All the participants will be followed up for 6 months.
Study intervention: Participants in the intervention group will receive semi-personalized text messages for 6 months as well as usual care. Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week. Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week.
Outcome measures: The primary endpoint is systolic blood pressure control. Secondary endpoints include a change in proportion of patients achieving a systolic blood pressure<140mm Hg, physical activity, medication adherence, smoking cessation, low-density lipoprotein cholesterol (LDL-C) and body mass index (BMI). Exploratory endpoints include long-term prognosis of the patients, such as death, non-fatal myocardial infarction, stroke and so on, as well as health status (SAQ and EQ-5D).
Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana
- Fuwai Hospital
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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:
- Participants with coronary artery disease defined as history of myocardial infarction and percutaneous coronary intervention (PCI)
- Capability to read and send text messages
Exclusion Criteria:
- History of diabetes
- Assumed poor adherence
- Do not have an active mobile phone
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
Los participantes en el grupo de control recibirán 2 mensajes de agradecimiento por mes y realizarán prácticas clínicas de rutina.
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Experimental: Intervention-Text messaging
Patients will receive regular semi-personalized text messages for 6 months.
Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am,
12noon, 4.00pm).
Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week.
Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week.
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Patients will receive regular semi-personalized text messages for 6 months.
Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am,
12noon, 4.00pm).
Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week.
Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week.
Prior to study commencement, a bank of 280 messages have been developed based on guidelines and behavior change theory (BCT), and have underwent multidisciplinary expert review and qualitative review process.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in systolic blood pressure obtained in office during each interview
Periodo de tiempo: Baseline; 6months
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The investigators will measure the change in systolic blood pressure from baseline to 6 months.
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Baseline; 6months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in proportion of patients achieving a SBP<140mm Hg
Periodo de tiempo: Baseline; 6months
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The investigators will measure the proportion of patients achieving a SBP<140mm Hg from baseline to 6 months.
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Baseline; 6months
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Change in low-density lipoprotein cholesterol (LDL-C) level
Periodo de tiempo: Baseline; 6months
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The investigators will measure the change in LDL-C level from baseline to 6 months.
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Baseline; 6months
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Change in body mass index (BMI)
Periodo de tiempo: Baseline; 6months
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The investigators will measure the change in BMI from baseline to 6 months.
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Baseline; 6months
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Change in medication adherence
Periodo de tiempo: Baseline; 6months
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The investigators will measure the change in medication adherence from baseline to 6 months.
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Baseline; 6months
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Change in level of physical activity measured via International Physical Activity Questionnaire (IPAQ) scale
Periodo de tiempo: Baseline; 6months
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The investigators will measure the change in IPAQ scale from baseline to 6 months.
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Baseline; 6months
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Change in proportion of non-smokers
Periodo de tiempo: Baseline; 6months
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The investigators will measure the proportion of non-smokers via self report and cotinine urine strip test from baseline to 6 months.
The patients who report as non-smokers with negative cotinine test result will be defined as non-smokers.
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Baseline; 6months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Harlan M Krumholz, MD, SM, Yale University
- Investigador principal: Lixin Jiang, MD, PhD, China National Center for Cardiovascular Disease
Publicaciones y enlaces útiles
Publicaciones Generales
- Huo X, Spatz ES, Ding Q, Horak P, Zheng X, Masters C, Zhang H, Irwin ML, Yan X, Guan W, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM, Jiang L. Design and rationale of the Cardiovascular Health and Text Messaging (CHAT) Study and the CHAT-Diabetes Mellitus (CHAT-DM) Study: two randomised controlled trials of text messaging to improve secondary prevention for coronary heart disease and diabetes. BMJ Open. 2017 Dec 21;7(12):e018302. doi: 10.1136/bmjopen-2017-018302. Erratum In: BMJ Open. 2018 Jan 21;8(1):e018302corr1.
- Zheng X, Spatz ES, Bai X, Huo X, Ding Q, Horak P, Wu X, Guan W, Chow CK, Yan X, Sun Y, Wang X, Zhang H, Liu J, Li J, Li X, Spertus JA, Masoudi FA, Krumholz HM. Effect of Text Messaging on Risk Factor Management in Patients With Coronary Heart Disease: The CHAT Randomized Clinical Trial. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005616. doi: 10.1161/CIRCOUTCOMES.119.005616.
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201502009-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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