Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients (SPASCPM)
19 de maio de 2022 atualizado 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
86
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in quality of life
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in medication compliance
Prazo: 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
Prazo: Baseline and 1 and 6 months
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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
Prazo: Baseline and 1 and 6 months
|
Diastolic 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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Changes in serum total cholesterol
Prazo: Baseline and 1 and 6 months
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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
Prazo: Baseline and 1 and 6 months
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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
Prazo: Baseline and 1 and 6 months
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Serum high-density lipoproteincholesterol 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 low-density lipoproteincholesterol
Prazo: Baseline and 1 and 6 months
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Serum low-density lipoproteincholesterol 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Jingwen Hu, Master, First Affiliated Hospital Xi'an Jiaotong University
Publicações e links úteis
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Publicações Gerais
- 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].
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de setembro de 2016
Conclusão Primária (Real)
1 de abril de 2017
Conclusão do estudo (Real)
1 de maio de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
13 de julho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de julho de 2016
Primeira postagem (Estimativa)
28 de julho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de maio de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de maio de 2022
Última verificação
1 de abril de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- XAJTUFH2016
- 2016JM8116 (Número de outro subsídio/financiamento: Science and Technology Department of Shaanxi Province, China)
Plano para dados de participantes individuais (IPD)
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INDECISO
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