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临床试验/NCT03904589
NCT03904589已完成不适用

Questionnaires Assessing the Quality of Life of Patients Treated for Coronary Heart Disease: a Pilot Study to Establish Outcome Indicators for Care Pathways From the Patient's Point of View

José Castro1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2016年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
201
试验地点
1
主要终点
Patient Health Questionnaire (PHQ-2)

研究概览

简要总结

Cardiovascular disease remains the leading cause of death in Europe and worldwide. In 2014, they led to more than 4 million deaths in Europe, and coronary heart disease alone accounts for nearly 1.8 million deaths, or 20% of all deaths in Europe. However, mortality from cardiovascular disease and, especially, coronary heart disease has declined in recent decades. This has been made possible by improving the quality of care provided to patients. Several studies have been conducted to demonstrate this improvement in the quality of care, but they mainly measure the functional results of treatment, morbidity and mortality, survival and prolongation of life.

However, patient-centered outcomes such as health-related quality of life outcomes (such as mental function, ability to resume activities of daily living, social relationship) are also considered important outcomes in the management and monitoring of these diseases. Some studies have shown that, even when other risks factors are controlled, a poor quality of life related to health is a prediction factor for morbidity and mortality in patients with coronary artery disease.

Some studies have suggested that health-related quality of life should be strongly associated with lifestyle, co-morbidities, and mental function.

Some factors have been identified as factors that may affect the quality of life in patients with coronary artery disease, including depression, anxiety, dyspnea and angina pectoris. Depression and anxiety were negatively associated with health-related quality of life in patients with cardiovascular disease. As for dyspnea, it has been shown that in stable patients who have had a myocardial infarction, its increase at 1 month after initiation of treatment is strongly associated with a decrease in the quality of life and with an increased risk of re-hospitalization and death. It is therefore important to measure these factors when the quality of life is assessed in patients with coronary heart disease.

The importance of assessing quality of life is that the clinician and the patient often have different concerns: what the clinician considers to be a "successful procedure" is not always considered as such by the patient. Results related to quality of life (results rarely evaluated) are among the results that really interest the patient. Indeed, many patients consider the quality of additional years of life acquired as important as the lifespan, so the goal of today's medicine is to improve the quantity and quality of life of the additional years of life acquired. To ensure this improvement, the assessment of health-related quality of life should be integrated into the daily clinical practice of coronary heart disease management.

The objective of our study is to evaluate the feasibility of this practice throughout the traject of care, by using several standardized questionnaires.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed coronary disease

排除标准

  • Emergencies, patients lost to follow-up.

结局指标

主要结局

Patient Health Questionnaire (PHQ-2)

时间窗: 6 months after hospital admission

Patient Health Questionnaire (PHQ-2) questionnaire used to assess depression. The score is calculated on a scale of 0 (= low possibility of having symptoms related to depression) to 6 (= high possibility of having symptoms related to depression).

Seattle Angina Questionnaire (SAQ-7)

时间窗: 6 months after hospital admission

Seattle Angina Questionnaire (SAQ-7), validated and specific questionnaire of angina pectoris which deals with 5 dimensions of quality of life: physical limits, stability of angina, frequency of angina, perception of the disease, satisfaction with the treatment. Each domain has a score calculated on a scale of 0 (= worst health quality) to 100 (= best health quality).

次要结局

  • Percentage of autonomous filling(6 months after hospital admission)
  • Average filling time per questionnaire(6 months after hospital admission)
  • Rose Dyspnea Score(6 months after hospital admission)
  • Percentage of compliance(6 months after hospital admission)

研究者

发起方
José Castro
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

José Castro

Head of cardiology clinic

Brugmann University Hospital

研究点 (1)

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