Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598048
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2020-10-07
Brief Title:
Quality of Life Post-ACS in Participants From EMMACE
Sponsor:
University of Leeds
Organization:
University of Leeds
Study Overview
Official Title:
Quality of Life Post-ACS in Participants From EMMACE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
EMMACE-XL
Brief Summary:
EMMACE-XL will recruit participants who are survivors of acute coronary syndrome a type of heart attack to assess their health-related quality of life five years or more after their heart attack We will invite surviving participants from the EMMACE 3 and 4 studies to consent to participate in EMMACE-XL study they will be asked to complete one questionnaire relating to their health medication and lifestyle The questionnaire will be linked to their data collected as part of the EMMACE 3 and 4 studies including long term follow up data from NHS Digital
The data collected from all the studies will then be analysed to see if patient groups can be identified who are at risk of poorer quality of life and worse health outcomes These groups can then be targeted with the aim of improving their health outcomes
The study will use statistical methods to look at the relationship of factors such as medication adherence comorbidities and patient demographics on health-related quality of life and health outcomes
The data collected from all the studies will then be analysed to see if patient groups can be identified who are at risk of poorer quality of life and worse health outcomes These groups can then be targeted with the aim of improving their health outcomes
The study will use statistical methods to look at the relationship of factors such as medication adherence comorbidities and patient demographics on health-related quality of life and health outcomes
Detailed Description:
Health-related quality of life HRQoL after myocardial infarction MI is an important clinical outcome It allows the definition of health outcomes from a patients perspective and therefore offers the potential to collect patient-centered ill-health which may be used as an additional endpoint in the evaluation of care Many survivors of MI experience poor HRQoL and many patients consider the quality of additional life years gained just as important as the length of life The goal of contemporary therapies therefore should be not only to extend life expectancy but also to ensure a high quality long-term health state Accordingly HRQoL is increasingly being used as an outcome measure in clinical trials evaluating both the impact of disease burden and the effectiveness of cardiovascular interventions
Research has shown that changes in HRQoL are associated with a range of clinical outcomes including death anxiety and depression and medications compliance Changes in HRQoL have been reported to negatively impact healthcare costs and employment However there is a paucity of information about the relationship between HRQoL and clinical outcomes inherent following MI Moreover previous research is limited by small sample sizes poor generalisabilityselection bias the use of retrospective cross-sectional designsand short follow-up durations of 6 months - 2 years For example in our previous studies EMMACE 3 and 4 we followed up patients for up to 2 years The EMMACE data analysis showed that over two years HRQoL improved for the majority two thirds but was significantly worse and more likely to decline for women NSTEMI and people with long-term health conditions
Whilst the analysis of EMMACE demonstrates promising results the EMMACE data are limited by the short follow up period of up to 2 years We have been funded by the British Heart Foundation Program grant number PG195434511 to link the EMMACE 3 and 4 data to ONS mortality and Hospital Episode Statistics HES data such that longer-term non-fatal and fatal outcomes and healthcare utilisation may be studied All patients were consented to enter the EMMACE 3 and 4 studies and for their self-reported data to be linked to future electronic health record data EMMACE data has already been successfully linked to data from the national heart attack registry Myocardial Ischemia National Audit project MINAP thus providing information about hospital treatment for MI and comorbidities This study will provide a further follow up of this data so that longer term follow up can be studied
To complement our work and given the paucity on longer term HRQoL data in this proposal we aim to collect 5 years HRQoL measures data from the participants of EMMACE 3 4 studies The longer follow up of HRQoL data 5 years may provide insights into understanding the association between long term changes in HRQoL and subsequent clinical outcomes and precisely in whom worse or better outcomes may occur will permit the design and testing of novel intervention to reduce premature death from MI
The planned research will provide unique and comprehensive insight into the relationship between changes in HRQoL and survival following MI Health-related quality of life is a patient reported outcome measure PROM which can detect change in risk of events for patients and potentially serve as a predictor of future risk using patient-facing data capture tools Understanding the association between changes in HRQoL and health outcomes and precisely in whom worse or better outcomes may occur will permit the design and testing of novel interventions to reduce premature death from MI
Research has shown that changes in HRQoL are associated with a range of clinical outcomes including death anxiety and depression and medications compliance Changes in HRQoL have been reported to negatively impact healthcare costs and employment However there is a paucity of information about the relationship between HRQoL and clinical outcomes inherent following MI Moreover previous research is limited by small sample sizes poor generalisabilityselection bias the use of retrospective cross-sectional designsand short follow-up durations of 6 months - 2 years For example in our previous studies EMMACE 3 and 4 we followed up patients for up to 2 years The EMMACE data analysis showed that over two years HRQoL improved for the majority two thirds but was significantly worse and more likely to decline for women NSTEMI and people with long-term health conditions
Whilst the analysis of EMMACE demonstrates promising results the EMMACE data are limited by the short follow up period of up to 2 years We have been funded by the British Heart Foundation Program grant number PG195434511 to link the EMMACE 3 and 4 data to ONS mortality and Hospital Episode Statistics HES data such that longer-term non-fatal and fatal outcomes and healthcare utilisation may be studied All patients were consented to enter the EMMACE 3 and 4 studies and for their self-reported data to be linked to future electronic health record data EMMACE data has already been successfully linked to data from the national heart attack registry Myocardial Ischemia National Audit project MINAP thus providing information about hospital treatment for MI and comorbidities This study will provide a further follow up of this data so that longer term follow up can be studied
To complement our work and given the paucity on longer term HRQoL data in this proposal we aim to collect 5 years HRQoL measures data from the participants of EMMACE 3 4 studies The longer follow up of HRQoL data 5 years may provide insights into understanding the association between long term changes in HRQoL and subsequent clinical outcomes and precisely in whom worse or better outcomes may occur will permit the design and testing of novel intervention to reduce premature death from MI
The planned research will provide unique and comprehensive insight into the relationship between changes in HRQoL and survival following MI Health-related quality of life is a patient reported outcome measure PROM which can detect change in risk of events for patients and potentially serve as a predictor of future risk using patient-facing data capture tools Understanding the association between changes in HRQoL and health outcomes and precisely in whom worse or better outcomes may occur will permit the design and testing of novel interventions to reduce premature death from MI
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PG195434511 | OTHER_GRANT | British Heart Foundation | None |
| 276202 | OTHER | None | None |