Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients (SPASCPM)
19 de mayo de 2022 actualizado por: First Affiliated Hospital Xi'an Jiaotong University
Effects of a Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients After Coronary Intervention Treatment: a Randomized Controlled Trial
The purpose of the study is to investigate the effects of smart phone app on the secondary prevention for patients with coronary heart disease post percutaneous coronary intervention.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The secondary prevention for patients with coronary heart disease post percutaneous coronary intervention (PCI) proved associated with a significant reduction in mortality rates and improvement in quality of life.
For the limitation of socio-economic conditions, not all patients post PCI are in a position to receive continuous standardized secondary prevention management.
Therefore a smart phone app for secondary prevention management post PCI will be installed on patients' smart phones in order to investigate its effects on risk factors control, medication compliance, as well as quality of life and adverse cardiac events in the next six months post discharge.
Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary heart disease.
Patients in app group and control group will be interviewed by telephone at the 2nd week and the 3rd month, and at the 1st month and 6th month they will return our hospital for face to face follow-up and to compliance and medication adjustment, assessment of life quality, risk factors control and medication adherence.
Tipo de estudio
Intervencionista
Inscripción (Actual)
86
Fase
- No aplica
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 a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- First diagnosis of coronary heart disease and received a PCI treatment.
- Age 18-65 years.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Speech communication barriers.
- Patients with a clear history of allergies to anti-platelet drugs.
- Patients with a clear history of allergies to anti-platelet ᵦ-blockers.
- Patients with a clear history of allergies to statin drugs.
- Patients with a clear history of allergies to antihypertensive drugs.
- Patients with a clear history of allergies to antidiabetic drugs.
- Patients with serious heart failure(better than NYHA class II).
- Patients with cerebral infarction or cerebral hemorrhage.
- Patients with liver dysfunction (AST and ALT> 2 times that of the reference value).
- Patients with kidney dysfunction (creatinine clearance rate< 60ml/min).
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Smart phone app
The app contains education materials for secondary prevention of coronary artery disease.
So patients can access them very easily.
The app pushes heath management recommendation information on the timeline after percutaneous coronary intervention, and also provides health care lecture to help patients to improve their secondary prevention.
And online or telephone consultation ways are integrated into the App to provide convenience for patients to communicate with health care professionals.
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App for this study is provided with real time updating educational materials, reminder, and consultation for improving secondary prevention, and the related information is pushed to a patient in chronological order after his or her PCI operation.
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Otro: Control group
Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary artery disease.
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A guideline booklet with general advice on secondary prevention of coronary artery disease.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in quality of life
Periodo de tiempo: Baseline and 1 and 6 months
|
Seatt1e Angina Questionnaire
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Baseline and 1 and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in medication compliance
Periodo de tiempo: Baseline and 1 and 6 months
|
Percent of prescribed antiplatelet drug，ᵦ-blocker，angiotensin converting enzyme inhibitor，angiotensin II receptor blocker and statins taken during the past 1 and 6 monthers
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Baseline and 1 and 6 months
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Change in systolic blood
Periodo de tiempo: Baseline and 1 and 6 months
|
systolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
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Baseline and 1 and 6 months
|
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Change in diastolic blood pressure
Periodo de tiempo: Baseline and 1 and 6 months
|
Diastolic blood pressure is measured via pressuremercury sphygmomanometer and recored in the unit of mmHg.
|
Baseline and 1 and 6 months
|
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Changes in serum total cholesterol
Periodo de tiempo: Baseline and 1 and 6 months
|
Serum total cholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
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Baseline and 1 and 6 months
|
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Changes in serum triglyceride
Periodo de tiempo: Baseline and 1 and 6 months
|
Serum triglyceride is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
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Baseline and 1 and 6 months
|
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Changes in serum high-density lipoproteincholesterol
Periodo de tiempo: Baseline and 1 and 6 months
|
Serum high-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
|
Baseline and 1 and 6 months
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Changes in serum low-density lipoproteincholesterol
Periodo de tiempo: Baseline and 1 and 6 months
|
Serum low-density lipoproteincholesterol is measured by automatic biochemistry analyzer and recorded in the unit of mmol/L.
|
Baseline and 1 and 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jingwen Hu, Master, First Affiliated Hospital Xi'an Jiaotong University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52. doi: 10.1016/S0140-6736(04)17018-9.
- Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.
- Bommer WJ. Coronary revascularization: then, now, future trends. Rev Cardiovasc Med. 2014;15(2):176-7. doi: 10.3909/ricm15-2CAACC. No abstract available.
- White CJ. The future of interventional cardiology. Catheter Cardiovasc Interv. 2013 Jan 1;81(1):4-5. doi: 10.1002/ccd.24734. No abstract available.
- Sim DS, Kim JH, Jeong MH. Differences in Clinical Outcomes Between Patients With ST-Elevation Versus Non-ST-Elevation Acute Myocardial Infarction in Korea. Korean Circ J. 2009 Aug;39(8):297-303. doi: 10.4070/kcj.2009.39.8.297. Epub 2009 Aug 27.
- Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.
- Heo J, Chun M, Lee KY, Oh YT, Noh OK, Park RW. Effects of a smartphone application on breast self-examination: a feasibility study. Healthc Inform Res. 2013 Dec;19(4):250-60. doi: 10.4258/hir.2013.19.4.250. Epub 2013 Dec 31.
- Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226. Erratum In: Obesity (Silver Spring). 2016 Feb;24(2):536. Bennett, G B [Corrected to Bennett, G G].
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)
20 de septiembre de 2016
Finalización primaria (Actual)
1 de abril de 2017
Finalización del estudio (Actual)
1 de mayo de 2017
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2016
Primero enviado que cumplió con los criterios de control de calidad
27 de julio de 2016
Publicado por primera vez (Estimar)
28 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2022
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XAJTUFH2016
- 2016JM8116 (Otro número de subvención/financiamiento: Science and Technology Department of Shaanxi Province, China)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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