Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776681
Status:
RECRUITING
Last Update Posted:
2023-06-22
First Post:
2021-02-18
Brief Title:
Living With Marfans and Your Aorta Surgical Outcomes Study
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
Living With Marfan Syndrome II the Psychosocial and Health-related Quality of Life Effects of Surgical Interventions for Aorto-vascular Manifestations LIMA II Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIMA II
Brief Summary:
Marfan Syndrome MFS is a genetic disease affecting the eyes skeleton heart and arteries Despite MFS affecting multiple organ systems cardiovascular manifestations are the most serious and life threatening Approximately 80 of adult MFS patients will have a dilated aortic root by age 40 years with aortic aneurysm and dissection the leading causes of morbidity and mortality Living with a diagnosis of Marfan Syndrome including undergoing and recovering from heart surgery affects patients mental health well-being and quality of life in ways that are not well understood
This study will address the current knowledge gaps in this area and will provide the information needed to design interventions to help improve the MFS patients mental health well-being and quality of life after heart surgery The study will include adult MFS patients who are undergoing aorto-vascular surgery
The overall aim of the study is to explore the psychosocial and health-related quality of life HRQoL effects of the surgical interventions for aorto-vascular manifestations of MFS in 3 large UK cardiac centres To achieve this the researchers will ask the potential participants after obtaining informed consent to complete a series of accepted validated questionnaires to measure the health-related quality of life SF-36 and EQ5D questionnaire and psychosocial factors such as depression CES-D questionnaire fatigue Fatigue Severity Scale stigma Perceived Stigma Questionnaire self-esteem Rosenberg Self-esteem Scale pain and illness perception Illness Perception Questionnaire Participants will be asked to complete the questionnaires before surgery and at various time points after surgery at 6 weeks after hospital discharge and at 6 and 12 months after surgery The research team will also collect in-hospital post-operative morbidity burden following aorto-vascular surgery using cardiac post-operative morbidity score C-POMS tool from the patients and clinical records The association of C-POMS with psychosocial and HRQoL outcomes will also be examined
This study will address the current knowledge gaps in this area and will provide the information needed to design interventions to help improve the MFS patients mental health well-being and quality of life after heart surgery The study will include adult MFS patients who are undergoing aorto-vascular surgery
The overall aim of the study is to explore the psychosocial and health-related quality of life HRQoL effects of the surgical interventions for aorto-vascular manifestations of MFS in 3 large UK cardiac centres To achieve this the researchers will ask the potential participants after obtaining informed consent to complete a series of accepted validated questionnaires to measure the health-related quality of life SF-36 and EQ5D questionnaire and psychosocial factors such as depression CES-D questionnaire fatigue Fatigue Severity Scale stigma Perceived Stigma Questionnaire self-esteem Rosenberg Self-esteem Scale pain and illness perception Illness Perception Questionnaire Participants will be asked to complete the questionnaires before surgery and at various time points after surgery at 6 weeks after hospital discharge and at 6 and 12 months after surgery The research team will also collect in-hospital post-operative morbidity burden following aorto-vascular surgery using cardiac post-operative morbidity score C-POMS tool from the patients and clinical records The association of C-POMS with psychosocial and HRQoL outcomes will also be examined
Detailed Description:
Marfan Syndrome MFS is a rare autosomal-dominant connective tissue disorder with pleiotropic manifestations primarily affecting the skeletal ocular and cardiovascular systems Despite MFS affecting multiple organ systems cardiovascular manifestations are the most serious and life threatening Approximately 80 of adult MFS patients will have a dilated aortic root by age 40 years with aortic aneurysm and dissection the leading causes of morbidity and mortality However there is limited evidence worldwide on health-related quality of life HRQoL and psychosocial aspects of the recovery of MFS patients undergoing surgical intervention Undergoing a heart operation can be a stressful and life-threatening experience involving a lot of uncertainties long periods of absence from work and social activities as well as limitation on physical activities which can potentially lead to psychosocial problems and poor health-related quality of life Therefore there is a specific need for high quality descriptive and exploratory research in this area
The overarching aim of this prospective observational cohort study is to explore the psychosocial and HRQoL effects of surgical interventions for aorto-vascular manifestations of MFS in three large UK cardiac centres Potential participants will be recruited from the outpatient pre-admission clinic HRQoL and psychosocial factors will be determined and quantified using validated questionnaires before surgery and at various time points after surgery at 6 weeks after hospital discharge and at 6 and 12 months after surgery The questionnaires will be delivered either in paper or electronic format depending on participants preference In-hospital post-operative morbidity burden following aorto-vascular surgery using cardiac post-operative morbidity score C-POMS tool will also be determined from the patients and clinical records and its association with psychosocial and HRQoL outcomes will be examined
The outcome of the study will significantly contribute to the UK and international evidence-base on the HRQoL and psychosocial impact of the aorto-vascular surgical interventions on MFS patients and will provide clinicians with the foundation that will serve as basis for appropriate interventions The result will also be useful to better understand the condition and potentially guide the researchers in devising a patient care pathway that includes this aspect of care as well as develop a holistic and comprehensive service for this patient group
The overarching aim of this prospective observational cohort study is to explore the psychosocial and HRQoL effects of surgical interventions for aorto-vascular manifestations of MFS in three large UK cardiac centres Potential participants will be recruited from the outpatient pre-admission clinic HRQoL and psychosocial factors will be determined and quantified using validated questionnaires before surgery and at various time points after surgery at 6 weeks after hospital discharge and at 6 and 12 months after surgery The questionnaires will be delivered either in paper or electronic format depending on participants preference In-hospital post-operative morbidity burden following aorto-vascular surgery using cardiac post-operative morbidity score C-POMS tool will also be determined from the patients and clinical records and its association with psychosocial and HRQoL outcomes will be examined
The outcome of the study will significantly contribute to the UK and international evidence-base on the HRQoL and psychosocial impact of the aorto-vascular surgical interventions on MFS patients and will provide clinicians with the foundation that will serve as basis for appropriate interventions The result will also be useful to better understand the condition and potentially guide the researchers in devising a patient care pathway that includes this aspect of care as well as develop a holistic and comprehensive service for this patient group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None