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Impact of Text Messages to Promote Secondary Prevention After Acute Coronary Syndrome (IMPACS)

8 de mayo de 2018 actualizado por: Antonio Luiz Pinho Ribeiro, Federal University of Minas Gerais

Impact of a Mobile Phone Text Messages Intervention on the Secondary Prevention of Cardiovascular Events After Acute Coronary Syndrome

The study is a two-arm, parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization. Text messages will include information about lifestyle modifications, medication adherence and cardiovascular risk factor control. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive 4 pre-designed and semi-personalized text messages per week in addition to usual care for 6 months, while the control group will receive usual care.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Purpose of the trial: The purpose of the study is to evaluate the effectiveness of automated mobile phone text message-based intervention for secondary prevention after acute coronary syndrome hospitalization.

Trial design: Two-parallel arm, single-blind, block randomization.

Primary endpoint: The proportion achieving guideline levels of modifiable risk factors (LDL-C <70mg/dL, blood pressure <140/90 mm Hg, exercising regularly [≥5 d/wk × 30minutes of moderate exercise per session], nonsmoker status, and BMI <25). The investigators prespecified in the statistical analysis plan the efficacy variable of proportion achieving combined risk factor control (achieving risk factor targets in 4 or more of the 5 modifiable risk factors listed above) as a measure of a multiple risk factor effect.

Secondary endpoints: The plasma LDL-C level at 6 months, Level of physical activity, Blood Pressure, Medication adherence measured via Morisky scale, Proportion of non-smokers, Body mass index (BMI), Rates death and hospitalization up to 6 months.

Duration of follow-up: 6 months

Trial treatment:

Intervention: The treatment group will receive the usual discharge treatment, instructions and information for acute coronary syndrome patients as well as the text-messaging intervention. The program will include a variety of topics such as standard follow-up care reminders as well as general self-management and healthy living habits texts. There will be four streams: one for patients who are non-smokers and are free of diabetes; one for current/recent smokers; one for diabetic patients; and one for smoker and diabetic patients. Texts will be sent out 4 times per week for 180 days. All participants in the same stream will receive the same texts in the same order.

Control: The usual care group will receive standard discharge treatment, instructions, and information for patients with acute coronary syndrome. The participants will also receive SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly.

Expected sample size, enrollment and expected number of centers:

Sample size = 160 Recruitment start date: November, 2017 Recruitment end date: May, 2019 Follow-up end date: November, 2019 Number of centers: 1

Statistical considerations:

  • Intention to treat analysis
  • The trial has >90% power (2 sided alpha = 0.05) to detect 15% difference in achieving risk factor targets in 4 or more of the 5 modifiable risk factors listed.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

160

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Brasil
    • MG
      • Belo Horizonte, MG, Brasil, 30575210
        • Reclutamiento
        • Luiz Guilherme Passaglia
        • Contacto:
        • Investigador principal:
          • Luiz G Passaglia, M.D.
        • Investigador principal:
          • Antônio LP Ribeiro, M.D., Ph.D
        • Sub-Investigador:
          • Luisa CC Brant, M.D., Ph.D
        • Sub-Investigador:
          • Bruno R Nascimento, M.D., Ph.D.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Consecutive patients who have been hospitalized at the UFMG's University Hospital with primary or secondary diagnosis of Acute Coronary Syndrome and are discharged for outpatient follow-up;
  • Age ≥ 18 years, of both sexes;
  • Patients who are able to receive text messages by their own mobile phone.

Exclusion Criteria:

  • Refusal or inability to sign the Informed Consent.
  • Complete illiteracy.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: Experimental
Automated semi-personalized mobile phone text message-based intervention for secondary prevention plus usual care.
Conductual: Mobile phone text message
The treatment group will receive the usual discharge treatment, instructions and information for acute coronary syndrome patients as well as the text-messaging intervention. The program will include a variety of topics such as standard follow-up care reminders as well as general self-management and healthy living habits texts. There will be four streams: one for patients who are non-smokers and are free of diabetes; one for current/recent smokers; one for diabetic patients; and one for smoker and diabetic patients. Texts will be sent out 4 times per week for 180 days. All participants in the same stream will receive the same texts in the same order. The usual care group will receive standard discharge treatment, instructions, and information for patients with acute coronary syndrome. They will also receive simple and short text messages related to the importance of trial participation.
Sin intervención: No Intervention
Usual Care

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Escore of combined risk factor control
Periodo de tiempo: 6 months
The proportion achieving guideline levels of modifiable risk factors (LDL-C <77mg/dL, blood pressure <140/90 mm Hg, exercising regularly [≥5 d/wk × 30minutes of moderate exercise per session], nonsmoker status, and BMI <25). We prespecified in the statistical analysis plan the efficacy variable of proportion achieving combined risk factor control (achieving risk factor targets in 4 or more of the 5 modifiable risk factors listed above) as a measure of a multiple risk factor effect
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Plasma LDL-C level
Periodo de tiempo: 6 months
Fasting blood sample
6 months
Level of physical activity (measured via
Periodo de tiempo: 6 months
Measured by research blinded to treatment allocation - The level of physical activity will be mensured by the International Physical Activity Questionnaire Short Form (IPAQ-SF) and it will be validated in one-fifth of the participants by using accelerometers
6 months
Blood Pressure
Periodo de tiempo: 6 months
Measured by research blinded to treatment allocation - 3 resting, sitting digital recordings, mean of last 2 readings
6 months
Proportion of non-smokers
Periodo de tiempo: 6 months
Measured by research blinded to treatment allocation - Self-reported smoking / quitting attempts will be confirmed with a Carbon Monoxide Meter Breath Test
6 months
Body mass index (BMI)
Periodo de tiempo: 6 months
Measured by research blinded to treatment allocation
6 months
Medication adherence (measured via "Medida de adesão aos tratamentos" - MAT)
Periodo de tiempo: 6 months
Measured by research blinded to treatment allocation It is an instrument composed of seven items that evaluate the behavior of the individual in relation to daily use of medicines. The answers are obtained by means of a six-point ordinal scale that varies from always (1) to never (6). The values obtained with the answers to the seven items are summed and divided by the number of items (values vary from 1 to 6). Subsequently, values 5 and 6 are computed as one (adherent) and the others are computed as zero (non-adherent).
6 months
Death from any cause
Periodo de tiempo: 6 months
Medical records and database
6 months
Rehospitalization
Periodo de tiempo: 6 months
Self-report, medical records and database
6 months
Cardiovascular death
Periodo de tiempo: 6 months
Medical records and database
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Federal University of Minas Gerais

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de noviembre de 2017

Finalización primaria (Anticipado)

1 de mayo de 2019

Finalización del estudio (Anticipado)

1 de noviembre de 2019

Fechas de registro del estudio

Enviado por primera vez

14 de enero de 2018

Primero enviado que cumplió con los criterios de control de calidad

26 de enero de 2018

Publicado por primera vez (Actual)

29 de enero de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de mayo de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

8 de mayo de 2018

Última verificación

1 de mayo de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CEP1.883.227

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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