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Inherited and Non-inherited Cardiac Disease Quality of Life (Cardiac QOL)

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ClinicalTrials.gov Identifier: NCT04080492
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Milind Desai, The Cleveland Clinic

Brief Summary:
A prospective, longitudinal, non-comparator, non-randomized observational cohort study to assess the quality of life in adult patients affected by inherited cardiac disease (hypertrophic cardiomyopathy and thoracic aortic aneurysm) who are not amenable to surgery, as well as those affected by non-inherited cardiac disease caused by radiation therapy.

Condition or disease Intervention/treatment
Hypertrophic Obstructive Cardiomyopathy Thoracic Aortic Aneurysm Heart Disease Caused by Ionising Radiation Quality of Life Other: QOL Survey

Detailed Description:

While physicians and patients may be aware of the physical limitations that result from a diagnosis of hypertrophic cardiomyopathy (HCM), thoracic aortic aneurysm (TAA) or radiation-induced heart disease (RIHD), there is little research on the impact on quality of life from the limitations imposed with these diagnosis. This study aims to address these unknowns in patients with inherited cardiac disease as well as non-inherited radiation-induced cardiac disease in first-time patients at the Cleveland Clinic. Knowledge gained from this study will provide us the ability for better management of the chronic impacts of the disease by identifying potential risk factors of low quality of life or changes in quality of life over time.

This is a prospective, longitudinal, non-comparator, non-randomized survey study describing QOL outcomes for patients with HCM, TAA, or RIHD. Patients being seen for the first time at the Cleveland Clinic for cardiac disease with no previous or scheduled surgery for HCM or TAA will electronically complete a Cardiac Quality of Life Survey at 3 time points (baseline, 3month & 9 month). The Cardiac Quality of Life Survey measures the participant's health status in five domains - global, physical ,emotional, social, and spiritual - as well as self-efficacy and resilience.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Assess the Quality of Life of Adults With Inherited and Non-inherited Cardiac Disease
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023


Group/Cohort Intervention/treatment
Inherited Cardiac Disease
Patients being seen for the first time at the Cleveland Clinic for Hypertrophic Cardiomyopathy or Thoracic Aortic Aneurysm.
Other: QOL Survey
The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and relationships. The spiritual section asks about the spiritual outlook on the burden of heart disease. Responses on a 5-level scale.

Non-inherited Cardiac Disease
Patients being seen for the first time at the Cleveland Clinic for Radiation-Induced Heart Disease.
Other: QOL Survey
The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and relationships. The spiritual section asks about the spiritual outlook on the burden of heart disease. Responses on a 5-level scale.




Primary Outcome Measures :
  1. Cardiac Quality of Life Survey -Global domain assessed at baseline. [ Time Frame: Baseline visit ]
    The global domain of the Cardiac Quality of Life Survey assesses global health. Three questions related to 1) Perceived overall quality of life, 2) & 3) Satisfaction with overall health status and with heart health. The Perceived overall quality of life responses range from very poor =1 to very good =5. 2) & 3) Satisfaction responses range from very dissatisfied=1 to very satisfied=5. Total global domain score ranges from 3 to 15 points. The higher the score the less impact the cardiac disease has on quality of life.

  2. Global domain of Quality of Life Survey assessed 3 months after baseline as compared to the baseline. [ Time Frame: 3 months after baseline visit ]
    The global domain of the Cardiac Quality of Life Survey assesses global health. Three questions related to 1) Perceived overall quality of life, 2) & 3) Satisfaction with overall health status and with heart health. The Perceived overall quality of life responses range from very poor =1 to very good =5. 2) & 3) Satisfaction responses range from very dissatisfied=1 to very satisfied=5. Total global domain score ranges from 3 to 15 points. The higher the score the less impact the cardiac disease has on quality of life.

  3. Global domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline. [ Time Frame: 9 months after baseline visit ]
    The global domain of the Cardiac Quality of Life Survey assesses global health. Three questions related to 1) Perceived overall quality of life, 2) & 3) Satisfaction with overall health status and with heart health. The Perceived overall quality of life responses range from very poor =1 to very good =5. 2) & 3) Satisfaction responses range from very dissatisfied=1 to very satisfied=5. Total global domain score ranges from 3 to 15 points. The higher the score the less impact the cardiac disease has on quality of life.

  4. Cardiac Quality of Life Survey-Physical domain assessed at baseline. [ Time Frame: Baseline visit ]
    The physical domain of the Cardiac Quality of Life Survey assesses physical function. 13 questions. 1) Perception of overall physical health: responses ranging from 1=very poor to 5=very good. 2-6) Difficulty performing day-to-day physical tasks with responses ranging from 1=very easy to 5=very difficult. 7-13) Severity of heart disease symptoms affecting day-to-day physical activities: responses ranging from 1=never to 5=always. Total physical domain score ranges from 13 to 85. The higher the score the less impact the cardiac disease has on physical health.

  5. Physical domain of Cardiac Quality of Life Survey assessed 3 months after baseline visit as compared to baseline. [ Time Frame: 3 months after baseline visit ]
    The physical domain of the Cardiac Quality of Life Survey assesses physical function. 13 questions. 1) Perception of overall physical health: responses ranging from 1=very poor to 5=very good. 2-6) Difficulty performing day-to-day physical tasks with responses ranging from 1=very easy to 5=very difficult. 7-13) Severity of heart disease symptoms affecting day-to-day physical activities: responses ranging from 1=never to 5=always. Total physical domain score ranges from 13 to 85. The higher the score the less impact the cardiac disease has on physical health.

  6. Physical domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline [ Time Frame: 9 months after baseline visit ]
    The physical domain of the Cardiac Quality of Life Survey assesses physical function. 13 questions. 1) Perception of overall physical health: responses ranging from 1=very poor to 5=very good. 2-6) Difficulty performing day-to-day physical tasks with responses ranging from 1=very easy to 5=very difficult. 7-13) Severity of heart disease symptoms affecting day-to-day physical activities: responses ranging from 1=never to 5=always. Total physical domain score ranges from 13 to 85. The higher the score the less impact the cardiac disease has on physical health.

  7. Cardiac Quality of Life Survey: Emotional domain assessed at baseline. [ Time Frame: Baseline visit ]
    The emotional domain of the Cardiac Quality of Life Survey assesses emotional health. 23 questions. 1) Perception of overall emotional health: responses ranging from 1=very poor to 5=very good. 2) effect of heart disease-related physical limitations on emotional health: responses ranging from 1=always to 5=never. Eight questions asking about anxiety with responses ranging from 1=always to 5=never. Seven questions assessing depression are incorporated with responses ranging from 1=always to 5=never. 19-23) affects from a traumatic event related to their health: responses ranging from 1=always to 5=never. Total emotional domain score ranges from 23 to 115. The higher the score the less impact the cardiac disease has on emotional health.

  8. Emotional domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline. [ Time Frame: 3 months after baseline visit ]
    The emotional domain of the Cardiac Quality of Life Survey assesses emotional health. 23 questions. 1) Perception of overall emotional health: responses ranging from 1=very poor to 5=very good. 2) effect of heart disease-related physical limitations on emotional health: responses ranging from 1=always to 5=never. Eight questions asking about anxiety with responses ranging from 1=always to 5=never. Seven questions assessing depression are incorporated with responses ranging from 1=always to 5=never. 19-23) affects from a traumatic event related to their health: responses ranging from 1=always to 5=never. Total emotional domain score ranges from 23 to 115. The higher the score the less impact the cardiac disease has on emotional health.

  9. Emotional domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline. [ Time Frame: 9 months after baseline visit ]
    The emotional domain of the Cardiac Quality of Life Survey assesses emotional health. 23 questions. 1) Perception of overall emotional health: responses ranging from 1=very poor to 5=very good. 2) effect of heart disease-related physical limitations on emotional health: responses ranging from 1=always to 5=never. Eight questions asking about anxiety with responses ranging from 1=always to 5=never. Seven questions assessing depression are incorporated with responses ranging from 1=always to 5=never. 19-23) affects from a traumatic event related to their health: responses ranging from 1=always to 5=never. Total emotional domain score ranges from 23 to 115. The higher the score the less impact the cardiac disease has on emotional health.

  10. Social domain of Cardiac Quality of Life Survey assessed at baseline. [ Time Frame: Baseline visit ]
    The social domain of the Cardiac Quality of life survey assesses social interaction and relationships. 10 questions. 1) Overall social interaction and relationships: responses ranging from 1=very poor to 5=very good. 2) Effect of heart disease-related physical limitations on social interaction: responses ranging from 1=always to 5=never. 3-10) Confidence in social interaction with friends and family: responses ranging from 1=always to 5=never. Total social domain score ranges from 10 to 50. The higher the score, the less impact the cardiac disease has on social health.

  11. Social domain of Cardiac Quality of Life Survey assessed 3 months after baseline as compared to baseline. [ Time Frame: 3 months after baseline visit ]
    The social domain of the Cardiac Quality of life survey assesses social interaction and relationships. 10 questions. 1) Overall social interaction and relationships: responses ranging from 1=very poor to 5=very good. 2) Effect of heart disease-related physical limitations on social interaction: responses ranging from 1=always to 5=never. 3-10) Confidence in social interaction with friends and family: responses ranging from 1=always to 5=never. Total social domain score ranges from 10 to 50. The higher the score, the less impact the cardiac disease has on social health.

  12. Social domain of Cardiac Quality of Life Survey assessed 9 months after baseline as compared to baseline. [ Time Frame: 9 months after baseline visit ]
    The social domain of the Cardiac Quality of life survey assesses social interaction and relationships. 10 questions. 1) Overall social interaction and relationships: responses ranging from 1=very poor to 5=very good. 2) Effect of heart disease-related physical limitations on social interaction: responses ranging from 1=always to 5=never. 3-10) Confidence in social interaction with friends and family: responses ranging from 1=always to 5=never. Total social domain score ranges from 10 to 50. The higher the score, the less impact the cardiac disease has on social health.

  13. Spiritual domain of quality of life assessed at baseline visit in the outpatient clinic. [ Time Frame: Baseline visit ]
    The spiritual domain of the Cardiac Quality of life survey assesses attitudes patients have surrounding their faith and health status. 4 questions. One question asks about if one's faith helps in coping with heart-related problems with responses ranging from 1=strongly disagree to 5=strongly agree. Three questions ask about feelings of anger, injustice, and turmoil related to heart disease with responses ranging from 1=strongly agree to 5=strongly disagree. Total spiritual domain score ranges from 4 to 20. The higher the score, the less impact the cardiac disease has on spiritual health.

  14. Spiritual domain of quality of life assessed 3 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 3 months after baseline visit ]
    The spiritual domain of the Cardiac Quality of life survey assesses attitudes patients have surrounding their faith and health status. 4 questions. One question asks about if one's faith helps in coping with heart-related problems with responses ranging from 1=strongly disagree to 5=strongly agree. Three questions ask about feelings of anger, injustice, and turmoil related to heart disease with responses ranging from 1=strongly agree to 5=strongly disagree. Total spiritual domain score ranges from 4 to 20. The higher the score, the less impact the cardiac disease has on spiritual health.

  15. Spiritual domain of quality of life assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
    The spiritual domain of the Cardiac Quality of life survey assesses attitudes patients have surrounding their faith and health status. 4 questions. One question asks about if one's faith helps in coping with heart-related problems with responses ranging from 1=strongly disagree to 5=strongly agree. Three questions ask about feelings of anger, injustice, and turmoil related to heart disease with responses ranging from 1=strongly agree to 5=strongly disagree. Total spiritual domain score ranges from 4 to 20. The higher the score, the less impact the cardiac disease has on spiritual health.

  16. Self-efficacy assessed at baseline visit in the outpatient clinic. [ Time Frame: Baseline visit ]
    The self-efficacy domain of the Cardiac Quality of Life survey measures self-efficacy as it relates to symptoms of heart disease. Six questions from the Cardiac Self-Efficacy Questionnaire asks about confidence in controlling symptoms, controlling illness, and maintaining daily functioning with responses ranging from 1=strongly disagree to 5=strongly agree. Total self-efficacy score ranges from 6 to 30. The higher the score, the less impact the cardiac disease has on self-efficacy.

  17. Self-efficacy assessed 3 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 3 months after baseline visit ]
    The self-efficacy domain of the Cardiac Quality of Life survey measures self-efficacy as it relates to symptoms of heart disease. Six questions from the Cardiac Self-Efficacy Questionnaire asks about confidence in controlling symptoms, controlling illness, and maintaining daily functioning with responses ranging from 1=strongly disagree to 5=strongly agree. Total self-efficacy score ranges from 6 to 30. The higher the score, the less impact the cardiac disease has on self-efficacy.

  18. Self-efficacy assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
    The self-efficacy domain of the Cardiac Quality of Life survey measures self-efficacy as it relates to symptoms of heart disease. Six questions from the Cardiac Self-Efficacy Questionnaire asks about confidence in controlling symptoms, controlling illness, and maintaining daily functioning with responses ranging from 1=strongly disagree to 5=strongly agree. Total self-efficacy score ranges from 6 to 30. The higher the score, the less impact the cardiac disease has on self-efficacy.

  19. Resilience assessed at baseline visit in the outpatient clinic. [ Time Frame: Baseline visit ]
    The resilience domain of the Cardiac Quality of Life survey measures the ability to recover quickly from difficulties. 9 questions asking about adapting to change, coping with stress, overcoming obstacles, and handling unpleasant feelings with responses ranging from 1=strongly disagree to 5=strongly agree. Total resilience score ranges from 9 to 45. The higher the score, more resilient the participant is in facing problems related to cardiac disease.

  20. Resilience assessed 3 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 3 months after baseline visit ]
    The resilience domain of the Cardiac Quality of Life survey measures the ability to recover quickly from difficulties. 9 questions asking about adapting to change, coping with stress, overcoming obstacles, and handling unpleasant feelings with responses ranging from 1=strongly disagree to 5=strongly agree. Total resilience score ranges from 9 to 45. The higher the score, more resilient the participant is in facing problems related to cardiac disease.

  21. Resilience assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
    The resilience domain of the Cardiac Quality of Life survey measures the ability to recover quickly from difficulties. 9 questions asking about adapting to change, coping with stress, overcoming obstacles, and handling unpleasant feelings with responses ranging from 1=strongly disagree to 5=strongly agree. Total resilience score ranges from 9 to 45. The higher the score, more resilient the participant is in facing problems related to cardiac disease.

  22. Impact of heritability of cardiac disease assessed at baseline visit in the outpatient clinic. [ Time Frame: Baseline visit ]
    Patients with thoracic aortic aneurysm or hypertrophic cardiomyopathy were asked questions about how the heritability of their cardiac disease affected their quality of life. 4 questions asking about how heritable cardiac disease affects the health and happiness of family members with responses ranging from 1=always to 5=never. Total score ranges from 4 to 20. The higher the score, the less impact the heritability of the cardiac disease as on the quality of life of the patient.

  23. Impact of heritability of cardiac disease assessed 3 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 3 months after baseline visit ]
    Patients with thoracic aortic aneurysm or hypertrophic cardiomyopathy were asked questions about how the heritability of their cardiac disease affected their quality of life. 3 questions asking about how heritable cardiac disease affects the health and happiness of family members with responses ranging from 1=always to 5=never. Total score ranges from 3 to 15. The higher the score, the less impact the heritability of the cardiac disease as on the quality of life of the patient.

  24. Impact of heritability of cardiac disease assessed 9 months after baseline visit as compared to the baseline survey in the outpatient clinic. [ Time Frame: 9 months after baseline visit ]
    Patients with thoracic aortic aneurysm or hypertrophic cardiomyopathy were asked questions about how the heritability of their cardiac disease affected their quality of life. 3 questions asking about how heritable cardiac disease affects the health and happiness of family members with responses ranging from 1=always to 5=never. Total score ranges from 3 to 15. The higher the score, the less impact the heritability of the cardiac disease as on the quality of life of the patient.

  25. Impact of radiation-induced heart disease (RIHD) assessed at baseline visit in the outpatient clinic. [ Time Frame: Baseline visit ]
    RIHD patients are asked about radiation therapy history, awareness of risk of RIHD, and impact on QOL. 7 questions. One question asks about time since last radiation therapy, ranging from 1= less than 5 years ago to 5=more than 30years ago. Another asks about time since RIHD diagnosis, ranging from 1=within the past week to 5=more than five years ago. One question asks about the duration of time between the symptoms of RIHD and diagnosis of RIHD with responses ranging from 1= less than 1 month to 5=more than 1 year. One question asks about the awareness of risk of RIHD before radiation therapy with responses ranging from 1=strongly disagree to 5=strongly agree. These four questions were not totaled. Three questions ask about the overall QOL before and after RIHD diagnosis and after treatment for RIHD. Responses ranged from 1=very poor to 5=very good. Total score for this section ranges from 3 to 15 with a higher score indicating RIHD had less of an impact on the overall QOL.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The study will include first-time patients being seen at the Cleveland Clinic whose information will be collected in-person and remotely. Patients included in the first arm of this study will be adults with hypertrophic cardiomyopathy and aortic aneurysm. Those included in the second arm of this study will be adults with radiation-induced heart disease.
Criteria

Inclusion Criteria:

  • Patients aged 18-70 at time of consent with a confirmed diagnosis of HCM, TAA, and/or RIHD being seen at CC Main Campus for a comprehensive clinical cardiac evaluation (i.e. physician, surgeon, nurse practitioner, geneticist, testing, imaging, etc) to define treatment plan for either diagnosis as per Cleveland Clinic provider.
  • Patient or an individual in their social support network has the equipment (phone, computer, tablet) and internet connection to complete the emailed follow-up questionnaires.

Exclusion Criteria:

  • Previously had surgery or plans to have surgery (full/mini sternotomy or endovascular) in the next nine months for HCM or TAA.
  • Inability or unwillingness to comply with study requirements in the opinion of the investigator.
  • Inability to provide informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080492


Contacts
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Contact: Milind Desai, M. D. 216-445-5250 desaim2@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Milind Desai, MD    216-445-5250    Desaim2@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Milind Desai, M. D. The Cleveland Clinic
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Responsible Party: Milind Desai, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04080492    
Other Study ID Numbers: 19-1007
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Aneurysm
Cardiomyopathies
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Cardiomyopathy, Hypertrophic
Cardiovascular Diseases
Vascular Diseases
Aortic Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases