Clinical trial NCT03904589: Questionnaires Assessing the Quality of Life of Patients Treated for Coronary Heart Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 consecutive patients\> 18 years of age admitted to the CHU Brugmann Hospital for coronary artery disease for whom a medical or surgical treatment is considered.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Confirmed coronary disease

Exclusion Criteria:

Emergencies, patients lost to follow-up.

Primary outcomes:
measure: Seattle Angina Questionnaire (SAQ-7)
timeFrame: Baseline - at hospital admission
measure: Seattle Angina Questionnaire (SAQ-7)
timeFrame: 1 month after hospital admission
measure: Seattle Angina Questionnaire (SAQ-7)
timeFrame: 6 months after hospital admission
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: Baseline - at hospital admission
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: 1 month after hospital admission
measure: Patient Health Questionnaire (PHQ-2)
timeFrame: 6 months after hospital admission
Secondary outcomes:
measure: Rose Dyspnea Score
timeFrame: Baseline - at hospital admission
measure: Rose Dyspnea Score
timeFrame: 1 month after hospital admission
measure: Rose Dyspnea Score
timeFrame: 6 months after hospital admission
measure: Percentage of autonomous filling
timeFrame: 6 months after hospital admission
measure: Percentage of compliance
timeFrame: 6 months after hospital admission
measure: Average filling time per questionnaire
timeFrame: 6 months after hospital admission
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Sarah Nyangore
role: PRINCIPAL_INVESTIGATOR
References: