Acute Myocardial InfarctionNCT01407146
Acute Coronary Syndrome and Care-Seeking Delay: A Web Based Behavioral Study
An observational study of Acute Myocardial Infarction and Heart Attack, run by Yale University at 1 site in United States.
Trial summary
The primary aim of this study is to increase our understanding of care-seeking behavior surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet based survey to ask individuals how they obtained medical care in the midst of a heart attack. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction, Heart Attack, Acute Coronary Syndrome
- How many people
- 2,381 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is designed to gather detailed information on the care-seeking behavior of ACS patients from a sample of sufficient size to allow testing of study hypotheses and provide points of intervention in the ACS care-seeking process. To obtain these data the study will employ a self-administered, self-tailoring web based survey instrument and a sampling design incorporating sampling quotas calculated from NHANES 1999-2000 and 2001-2002 studies to represent the population of the United States with AMI by age, gender, and race, and 2] over sampling of selected groups to meet calculated sampling quotas.
Inclusion Criteria: Acute myocardial infarction, acute coronary syndrome, unstable angina, men \& women, all races \& ethnicities
-
Exclusion Criteria: age < 21 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Nursing
New Haven, Connecticut, 06536
About this study
The primary aim of this study is to increase our understanding of care-seeking behavior surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet based survey to ask individuals how they obtained medical care in the midst of a heart attack. At present, care-seeking delay among individuals stricken with a heart attack prevents them from obtaining the full therapeutic benefit of hospital based medical care in a timely manner to reduce the long term health consequences of a heart attack. By using a self-tailoring survey instrument the study attempts to take into consideration the complex social processes by which the individual and their family make decisions to seek medical care for symptoms of a heart attack. The study is designed to obtain a national sample of ACS care-seeking behavior in the United States.
Read the detailed description
The primary aim of this study is to increase our understanding of care-seeking behavior surrounding acute coronary syndromes [ACS] through the application and testing of an integrated self-regulatory care-seeking model [ISCM] and the utilization of a world wide web [WWW] based ISCM survey instrument. At present, care-seeking delay among individuals stricken with ACS [acute myocardial infarction [AMI], unstable angina or sudden cardiac death] prevents many patients from obtaining the full therapeutic benefit of hospital based thrombolytic and/or mechanical reperfusion therapy to reduce the morbid and mortal consequences of acute cardiovascular disease [CVD]. Results from prior studies of ACS care-seeking delay generally rely on measures of time duration from acute symptom onset [ASO] to hospital emergency department [ED] arrival and measures of social demographic and clinical variables, extracted from emergency medical system [EMS] logs and/or ED charts. By relying on such limited data sources, these studies have failed to take into consideration the complexity of the social and behavioral processes by which individuals make decisions to seek medical care for symptoms of ACS.
By applying and testing an integrated self-regulatory care-seeking model [ISCM] to ACS care-seeking, it will be possible to delineate decision points and situations and circumstances that are critical to producing patterns of care-seeking that are efficient and expeditious or are protracted and delayed. The care-seeking process in the ISCM is viewed in terms of five analytic care-seeking phases from warning or premonitory symptoms to ED arrival. By noting the presence or absence of three central phases, it is possible to distinguish patterns of care-seeking and to record the duration of each care-seeking phase and total duration of each care-seeking path to the ED. The ISCM assumes that coping behaviors emerge over time and initially care-seeking behaviors are guided by demographic and structural factors. As the self-regulatory and coping processes emerge over the course of the ACS episode, the influence of these factors diminishes and emergent ACS evaluations, advice from others and health care providers, emerging symptoms and emotions, come to dominate the care-seeking process and directly determine the duration of ACS care-seeking. The study will test and explore the following hypotheses:
- Commonly used demographic variables, such as, age, sex, education and race will prove to be only one component, along with social situational and circumstantial, cognitive and emotional variables, that significantly influence the course and duration of ACS care-seeking.
- The ISCM will show that decision process variables associated with the care-seeking phases, the Self, Lay and Health Care Provider Phases, as shown in the Figure, are important predictors of time from symptoms onset to ED arrival and in the prediction of the length of time spent in each care-seeking phase.
- The ISCM will show differences in the total duration of the 5 most frequently occurring care-seeking paths to the ED and will explain most of the differences by the variables in Hypotheses 1 and 2.
- Conditional models of subjects who use key care-seeking phases, namely the Self, Lay and Health Care Provider Phases, will identify unique predictors of time in each phase.
- Significant interaction effects [model coefficient differences] will be found for important risk variables and socially important gender, age and racial groups. For example, African-Americans will show differences in model coefficients from Non-African-Americans.
The proposed study utilizes a twice tested pilot ISCM survey instrument placed on two secure dedicated web servers to collect patient care-seeking data. The target sample size for this study is 2,314 patients who have experienced an ACS episode. Subjects will be recruited using: 1] extensive marketing of the study URL on websites of interest to cardiac patients and oriented toward cardiac health and ACS risks, such as, diabetes or hypertension; 2] placement of study information on discussion boards and chat rooms with a cardiac health focus; 3] emailing of a study flyer PDF for posting in public libraries, senior citizen centers, African-American churches, county and municipal health clinics, and HMO web sites; 4] application of a viral marketing strategy; and 5] use of selected print media, for example, AARP publications. Marketing of the study site URL will emphasize the recruitment of women, the elderly and minorities. In the data collection phase of the study, the proportions of myocardial infarction and angina pectoris subjects falling into each cell of the cross classification of age, sex and race will be derived from NHANES 1999-2000 and 2001-2002 studies. These estimates of the population proportions in these cells will be used to determine quotas for each of the cells in an attempt to ensure all risk groups are adequately represented. We will over sample African-Americans. Statistical models will be used to estimate the effects of variables that characterize the decision process on the time delay until ED arrival. Time required to move from one phase of the decision process to the next will also be modeled, as will the different paths chosen by the subjects. Models will also include patient characteristics and other circumstantial and situational variables in the decision process.
- Keywords
- acute myocardial infarction, care-seeking behavior, acute coronary syndrome, care-seeking delay, cardiac delay, prehospital delay, acute myocardial infarction & PTSD, help seeking behaviors, seeking treatment, cardiac patients, decision time
- Medical subject headings
- Myocardial Infarction, Acute Coronary Syndrome, Angina, Unstable, Stress Disorders, Post-Traumatic, Help-Seeking Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision points and situations and circumstances critical to producing patterns of care-seeking that are efficient and expeditious or are protracted and delayed.
By applying an integrated self-regulatory care-seeking model [ISCM] to ACS care-seeking, we can delineate decision points and circumstances that are critical to producing patterns of care-seeking that are expeditious or delayed. The ISCM model assumes that coping behaviors emerge over time and are initially guided by demographic and structural factors. As the self-regulatory processes emerge, the influence of these factors diminishes and emergent ACS evaluations, advice from others and health care providers, emerging symptoms and emotions, come to determine the duration of ACS care-seeking.
Measured: Study participants will be asked to complete a survey of their heart attack care-seeking experiences. The survey will take from 30 minutes to 1 hour to complete depending on their care-seeking activities.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelo A Alonzo, PhD, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407146
- Sponsor's protocol ID
- 0711003286
- Other IDs
- 5R01HL085328-04
- Status last verified
- Apr 2020
- First submitted
- 28 Jul 2011
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Coronary Syndrome and Care-Seeking Delay: A Web Based Behavioral Study
- ClinicalTrials.gov ID
- NCT01407146
- Acronym / sponsor ID
- 0711003286
- Keywords
- acute myocardial infarction, care-seeking behavior, acute coronary syndrome, care-seeking delay, cardiac delay, prehospital delay, acute myocardial infarction & PTSD, help seeking behaviors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,381 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Ohio State University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to increase our understanding of care-seeking behavior surrounding heart attacks or acute coronary syndromes [ACS]. This study uses an internet based survey to ask individuals how they obtained medical care in the midst of a heart attack. At present, care-seeking delay among individuals stricken with a heart attack prevents them from obtaining the full therapeutic benefit of hospital based medical care in a timely manner to reduce the long term health consequences of a heart attack. By using a self-tailoring survey instrument the study attempts to take into consideration the complex social processes by which the individual and their family make decisions to seek medical care for symptoms of a heart attack. The study is designed to obtain a national sample of ACS care-seeking behavior in the United States.
Detailed description
The primary aim of this study is to increase our understanding of care-seeking behavior surrounding acute coronary syndromes [ACS] through the application and testing of an integrated self-regulatory care-seeking model [ISCM] and the utilization of a world wide web [WWW] based ISCM survey instrument. At present, care-seeking delay among individuals stricken with ACS [acute myocardial infarction [AMI], unstable angina or sudden cardiac death] prevents many patients from obtaining the full therapeutic benefit of hospital based thrombolytic and/or mechanical reperfusion therapy to reduce the morbid and mortal consequences of acute cardiovascular disease [CVD]. Results from prior studies of ACS care-seeking delay generally rely on measures of time duration from acute symptom onset [ASO] to hospital emergency department [ED] arrival and measures of social demographic and clinical variables, extracted from emergency medical system [EMS] logs and/or ED charts. By relying on such limited data sources, these studies have failed to take into consideration the complexity of the social and behavioral processes by which individuals make decisions to seek medical care for symptoms of ACS.
By applying and testing an integrated self-regulatory care-seeking model [ISCM] to ACS care-seeking, it will be possible to delineate decision points and situations and circumstances that are critical to producing patterns of care-seeking that are efficient and expeditious or are protracted and delayed. The care-seeking process in the ISCM is viewed in terms of five analytic care-seeking phases from warning or premonitory symptoms to ED arrival. By noting the presence or absence of three central phases, it is possible to distinguish patterns of care-seeking and to record the duration of each care-seeking phase and total duration of each care-seeking path to the ED. The ISCM assumes that coping behaviors emerge over time and initially care-seeking behaviors are guided by demographic and structural factors. As the self-regulatory and coping processes emerge over the course of the ACS episode, the influence of these factors diminishes and emergent ACS evaluations, advice from others and health care providers, emerging symptoms and emotions, come to dominate the care-seeking process and directly determine the duration of ACS care-seeking. The study will test and explore the following hypotheses:
- Commonly used demographic variables, such as, age, sex, education and race will prove to be only one component, along with social situational and circumstantial, cognitive and emotional variables, that significantly influence the course and duration of ACS care-seeking.
- The ISCM will show that decision process variables associated with the care-seeking phases, the Self, Lay and Health Care Provider Phases, as shown in the Figure, are important predictors of time from symptoms onset to ED arrival and in the prediction of the length of time spent in each care-seeking phase.
- The ISCM will show differences in the total duration of the 5 most frequently occurring care-seeking paths to the ED and will explain most of the differences by the variables in Hypotheses 1 and 2.
- Conditional models of subjects who use key care-seeking phases, namely the Self, Lay and Health Care Provider Phases, will identify unique predictors of time in each phase.
- Significant interaction effects [model coefficient differences] will be found for important risk variables and socially important gender, age and racial groups. For example, African-Americans will show differences in model coefficients from Non-African-Americans.
The proposed study utilizes a twice tested pilot ISCM survey instrument placed on two secure dedicated web servers to collect patient care-seeking data. The target sample size for this study is 2,314 patients who have experienced an ACS episode. Subjects will be recruited using: 1] extensive marketing of the study URL on websites of interest to cardiac patients and oriented toward cardiac health and ACS risks, such as, diabetes or hypertension; 2] placement of study information on discussion boards and chat rooms with a cardiac health focus; 3] emailing of a study flyer PDF for posting in public libraries, senior citizen centers, African-American churches, county and municipal health clinics, and HMO web sites; 4] application of a viral marketing strategy; and 5] use of selected print media, for example, AARP publications. Marketing of the study site URL will emphasize the recruitment of women, the elderly and minorities. In the data collection phase of the study, the proportions of myocardial infarction and angina pectoris subjects falling into each cell of the cross classification of age, sex and race will be derived from NHANES 1999-2000 and 2001-2002 studies. These estimates of the population proportions in these cells will be used to determine quotas for each of the cells in an attempt to ensure all risk groups are adequately represented. We will over sample African-Americans. Statistical models will be used to estimate the effects of variables that characterize the decision process on the time delay until ED arrival. Time required to move from one phase of the decision process to the next will also be modeled, as will the different paths chosen by the subjects. Models will also include patient characteristics and other circumstantial and situational variables in the decision process.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is designed to gather detailed information on the care-seeking behavior of ACS patients from a sample of sufficient size to allow testing of study hypotheses and provide points of intervention in the ACS care-seeking process. To obtain these data the study will employ a self-administered, self-tailoring web based survey instrument and a sampling design incorporating sampling quotas calculated from NHANES 1999-2000 and 2001-2002 studies to represent the population of the United States with AMI by age, gender, and race, and 2] over sampling of selected groups to meet calculated sampling quotas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decision points and situations and circumstances critical to producing patterns of care-seeking that are efficient and expeditious or are protracted and delayed.
Time frame: Study participants will be asked to complete a survey of their heart attack care-seeking experiences. The survey will take from 30 minutes to 1 hour to complete depending on their care-seeking activities.
By applying an integrated self-regulatory care-seeking model [ISCM] to ACS care-seeking, we can delineate decision points and circumstances that are critical to producing patterns of care-seeking that are expeditious or delayed. The ISCM model assumes that coping behaviors emerge over time and are initially guided by demographic and structural factors. As the self-regulatory processes emerge, the influence of these factors diminishes and emergent ACS evaluations, advice from others and health care providers, emerging symptoms and emotions, come to determine the duration of ACS care-seeking.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo A Alonzo, PhD principal investigator
Yale University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction and Heart Attack, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision points and situations and circumstances critical to producing patterns of care-seeking that are efficient and expeditious or are protracted and delayed. (time frame: Study participants will be asked to complete a survey of their heart attack care-seeking experiences. The survey will take from 30 minutes to 1 hour to complete depending on their care-seeking activities.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.