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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 25, 2000 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | July 1982 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00005157 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Speech Characteristics in Coronary Heart Disease |
| Official Title ICMJE | |
| Brief Summary | To improve the predictive validity of Structured Interview assessments of Type A behavior by comparing interviewer techniques in the Multiple Risk Factor Intervention Trial (MRFIT) and the Western Collaborative Group Study (WCGS). To assess whether there were interviewer differences in the predictiveness of Type A behavior and its components for coronary heart disease incidence in MRFIT and WCGS and if so, to assess whether the interviewer differences in disease predictiveness were related to interviewer stylistics. |
| Detailed Description | BACKGROUND: Individuals with Type A behavior are characterized as hard driving, competitive, and time urgent; when asked questions they are quick to answer with emphatic speech; they perceive themselves to be striving and competing and are prone to hostility. This core of behaviors is presumed to be on a continuum of intensity with well-developed Type A's at the upper end and well-developed Type B's at the lower end. Epidemiological studies have shown Type A's to have a higher prevalence and incidence of various forms of coronary heart disease than Type B's. The Structured Interview is a method of measuring Type A behavior in which a series of questions are administered about the individual's characteristic responses to situations relevant to the Type A behavior pattern, such as reaction to delay and reported frequency of anger. The Interview is delivered in challenging style designed to elicit Type A characteristics. In 1960, the WCGS recruited 3,154 employed men, ages 39 to 59, who were initially free of coronary heart disease and followed them for 8.5 years for coronary heart disease incidence. In 1972 MRFIT began recruiting 12,866 men, ages 35 to 57, selected for elevation of one or more risk factors, but free from coronary heart disease and followed them for an average of seven years after randomization to a risk factor modification group or to a control group referred to their own physicians for treatment. Both studies used the Structured Interview to assess Type A behavior. In 1981, Type A behavior was officially regarded as an independent risk factor for coronary heart disease, based largely on the findings of the WCGS. However, the MRFIT did not find Type A behavior to be related to coronary heart disease incidence. The manner of conducting the Structured Interview may have affected the predictive reliability of the Type A assessments. DESIGN NARRATIVE: Interviewer speech characteristics from the WCGS and MRFIT Structured Interview tape recordings were audited and analyzed. Each speech characteristic was scored with high reliability. Multiple logistic regression analyses were used to control for standard risk factors. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Natural History |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | November 1989 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | No eligibility criteria |
| Gender | Male |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00005157 |
| Responsible Party | |
| Study ID Numbers ICMJE | 1029 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) |
| Verification Date | May 2000 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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