Skip to content

Questionnaires Assessing the Quality of Life of Patients Treated for Coronary Heart Disease

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03904589
Enrollment
201
Registered
2019-04-05
Start date
2016-10-11
Completion date
2019-11-20
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

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.

Interventions

DIAGNOSTIC_TESTQuality of Life assessment

Quality of life will be assessed by means of the Seattle Angina Questionnaire and the Patient Health Questionnaire.

Sponsors

José Castro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Confirmed coronary disease

Exclusion criteria

Emergencies, patients lost to follow-up.

Design outcomes

Primary

MeasureTime frameDescription
Seattle Angina Questionnaire (SAQ-7)Baseline - at hospital admissionSeattle 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).
Patient Health Questionnaire (PHQ-2)Baseline - at hospital admissionPatient 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).

Secondary

MeasureTime frameDescription
Rose Dyspnea ScoreBaseline - at hospital admissionThe Rose Dyspnea Scale is a four-item questionnaire that assesses a patients' dyspnea level with common activities. One point is assigned to each activity associated with dyspnea. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea.
Percentage of autonomous filling6 months after hospital admissionPercentage of questionnaires filled autonomously by the patient
Percentage of compliance6 months after hospital admissionPercentage of questionnaires filled by the patient
Average filling time per questionnaire6 months after hospital admissionAverage time (in minutes) the patients need to fill one questionnaire

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026