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

• ClinicalTrials.gov Identifier: NCT03904589
• Recruitment Status: Unknown
• First Posted: April 5, 2019
• Last Update Posted: April 5, 2019
• Sponsor: José Castro
• Information provided by (Responsible Party): José Castro, Brugmann University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Coronary Heart Disease	Diagnostic Test: Quality of Life assessment

Study Design

• Study Type: Observational
• Estimated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: October 11, 2016
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Coronary Heart Disease	Diagnostic Test: Quality of Life assessment; Quality of life will be assessed by means of the Seattle Angina Questionnaire and the Patient Health Questionnaire.

Outcome Measures

Primary Outcome Measures :

1. Seattle Angina Questionnaire (SAQ-7) [ Time Frame: Baseline - at 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).
2. Seattle Angina Questionnaire (SAQ-7) [ Time Frame: 1 month 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).
3. Seattle Angina Questionnaire (SAQ-7) [ Time Frame: 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).
4. Patient Health Questionnaire (PHQ-2) [ Time Frame: Baseline - at 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).
5. Patient Health Questionnaire (PHQ-2) [ Time Frame: 1 month 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).
6. Patient Health Questionnaire (PHQ-2) [ Time Frame: 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).

Secondary Outcome Measures :

1. Rose Dyspnea Score [ Time Frame: Baseline - at hospital admission ]
   The 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.
2. Rose Dyspnea Score [ Time Frame: 1 month after hospital admission ]
   The 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.
3. Rose Dyspnea Score [ Time Frame: 6 months after hospital admission ]
   The 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.
4. Percentage of autonomous filling [ Time Frame: 6 months after hospital admission ]
   Percentage of questionnaires filled autonomously by the patient
5. Percentage of compliance [ Time Frame: 6 months after hospital admission ]
   Percentage of questionnaires filled by the patient
6. Average filling time per questionnaire [ Time Frame: 6 months after hospital admission ]
   Average time (in minutes) the patients need to fill one questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

Inclusion Criteria:

Confirmed coronary disease

Exclusion Criteria:

Emergencies, patients lost to follow-up.

Contacts and Locations

Contacts

Contact: Sarah Nyangore; Sarah.NYANGORE@chu-brugmann.be

Locations

Belgium

CHU Brugmann; Recruiting

Brussels, Belgium, 1020

Contact: Sarah Nyangore, MD Sarah.NYANGORE@chu-brugmann.be

Principal Investigator: Sarah Nyangore

Sponsors and Collaborators

José Castro

Investigators

• Principal Investigator: Sarah Nyangore; CHU Brugmann

More Information

• Responsible Party: José Castro, Head of cardiology clinic, Brugmann University Hospital
• ClinicalTrials.gov Identifier: NCT03904589
• Other Study ID Numbers: CHUB-Nyangore
• First Posted: April 5, 2019
• Last Update Posted: April 5, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases