Cardiovascular DiseasesNCT00005212
Work Organization and Cardiovascular Disease
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the combined effects of job strain and social isolation on cardiovascular morbidity and mortality. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 1988to Feb 1993
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the combined effects of job strain and social isolation on cardiovascular morbidity and mortality.
Read the detailed description
BACKGROUND:
Much of the medical and epidemiological research on the causes of cardiovascular disease has concentrated either on individual life style behaviors such as smoking and exercise or on biomedical risk factors such as hypertension, and diabetes. This research has provided the basis for improvements in personal health behaviors and in the treatment of hypertension which has reduced the incidence of cardiovascular disease in this country. However, even the best statistical models, incorporating all such risk factors, leave a significant proportion of cardiovascular disease mortality and morbidity unexplained. Major differences in cardiovascular disease rates have also been observed between different social classes and different societies. These findings have led epidemiologists and sociomedical researchers to investigate other types of variables, including psychosocial factors, such as personal predispositions, social support networks, and work-related stress. A series of studies, in a variety of disciplines, suggested that occupational stress may contribute to the development of cardiovascular disease.
A major source of data was the Swedish Survey of Living Conditions (ULF). The ULF was drawn from a sample which included the total occupational and demographic variation of an entire society. The survey contained information on age, sex, marital status, occupational class background and nationality of respondents and parents, residence, education, past employment history and income data.
DESIGN NARRATIVE:
In this non-concurrent prospective study, ten years of follow-up data were linked with five years of data from the Survey of Living Conditions collected between 1976 and 1980. Total and cause-specific mortality data were obtained from the Swedish National Death Registry and morbidity incidence data from the Registry of Hospitalizations. The relationship between the duration of exposure time and disease risk was examined utilizing occupational history information which was combined with Theorell's Occupational Psychosocial Scoring System. Logistic regression analysis was used to examine the relative risks associated with adverse work characteristics and to test for potential interactions and confounding effects. Cox's proportional hazards model was used as an approximation of life table methods. Analysis was performed separately for men and women.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startMar 1988
- Study completionFeb 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005212
- Sponsor's protocol ID
- 1091
- Other IDs
- R29HL039633
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Johnson JV, Hall EM. Job strain, work place social support, and cardiovascular disease: a cross-sectional study of a random sample of the Swedish working population. Am J Public Health. 1988 Oct;78(10):1336-42. doi: 10.2105/ajph.78.10.1336.
PubMed 3421392Johnson JV, Hall EM, Theorell T. Combined effects of job strain and social isolation on cardiovascular disease morbidity and mortality in a random sample of the Swedish male working population. Scand J Work Environ Health. 1989 Aug;15(4):271-9. doi: 10.5271/sjweh.1852.
PubMed 2772582Johnson JV, Hall EM: Social Support in the Work Environment and Cardiovascular Disease. In: Shumaker S, Czajkowski S (Eds.), Social Support and Cardiovascular Disease. New York: Plenum Press, in press, 1988
Johnson JV: Control, Collectively and the Psychosocial Work Environment. In: Sauter S, Hurrell J, Cooper C (Eds), Job Stress and Work Control. New York: Academic Press, in press, 1988
Johansson G, Johnson JV, Hall EM. Smoking and sedentary behavior as related to work organization. Soc Sci Med. 1991;32(7):837-46. doi: 10.1016/0277-9536(91)90310-9.
PubMed 2028279Hall EM, Johnson JV, Tsou TS. Women, occupation, and risk of cardiovascular morbidity and mortality. Occup Med. 1993 Oct-Dec;8(4):709-19.
PubMed 8303487Johnson JV, Stewart WF. Measuring work organization exposure over the life course with a job-exposure matrix. Scand J Work Environ Health. 1993 Feb;19(1):21-8. doi: 10.5271/sjweh.1508.
PubMed 8465168
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work Organization and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00005212
- Acronym / sponsor ID
- 1091
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Mar 1988
- Study completion
- Feb 1993 (actual)
- First posted
- 26 May 2000 (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.
To determine the combined effects of job strain and social isolation on cardiovascular morbidity and mortality.
Detailed description
BACKGROUND:
Much of the medical and epidemiological research on the causes of cardiovascular disease has concentrated either on individual life style behaviors such as smoking and exercise or on biomedical risk factors such as hypertension, and diabetes. This research has provided the basis for improvements in personal health behaviors and in the treatment of hypertension which has reduced the incidence of cardiovascular disease in this country. However, even the best statistical models, incorporating all such risk factors, leave a significant proportion of cardiovascular disease mortality and morbidity unexplained. Major differences in cardiovascular disease rates have also been observed between different social classes and different societies. These findings have led epidemiologists and sociomedical researchers to investigate other types of variables, including psychosocial factors, such as personal predispositions, social support networks, and work-related stress. A series of studies, in a variety of disciplines, suggested that occupational stress may contribute to the development of cardiovascular disease.
A major source of data was the Swedish Survey of Living Conditions (ULF). The ULF was drawn from a sample which included the total occupational and demographic variation of an entire society. The survey contained information on age, sex, marital status, occupational class background and nationality of respondents and parents, residence, education, past employment history and income data.
DESIGN NARRATIVE:
In this non-concurrent prospective study, ten years of follow-up data were linked with five years of data from the Survey of Living Conditions collected between 1976 and 1980. Total and cause-specific mortality data were obtained from the Swedish National Death Registry and morbidity incidence data from the Registry of Hospitalizations. The relationship between the duration of exposure time and disease risk was examined utilizing occupational history information which was combined with Theorell's Occupational Psychosocial Scoring System. Logistic regression analysis was used to examine the relative risks associated with adverse work characteristics and to test for potential interactions and confounding effects. Cox's proportional hazards model was used as an approximation of life table methods. Analysis was performed separately for men and women.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
Not reported in the source record.
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 18 Feb 2016.
- Background: PubMed 3421392Johnson JV, Hall EM. Job strain, work place social support, and cardiovascular disease: a cross-sectional study of a random sample of the Swedish working population. Am J Public Health. 1988 Oct;78(10):1336-42. doi: 10.2105/ajph.78.10.1336.
- Background: PubMed 2772582Johnson JV, Hall EM, Theorell T. Combined effects of job strain and social isolation on cardiovascular disease morbidity and mortality in a random sample of the Swedish male working population. Scand J Work Environ Health. 1989 Aug;15(4):271-9. doi: 10.5271/sjweh.1852.
- BackgroundJohnson JV, Hall EM: Social Support in the Work Environment and Cardiovascular Disease. In: Shumaker S, Czajkowski S (Eds.), Social Support and Cardiovascular Disease. New York: Plenum Press, in press, 1988
- BackgroundJohnson JV: Control, Collectively and the Psychosocial Work Environment. In: Sauter S, Hurrell J, Cooper C (Eds), Job Stress and Work Control. New York: Academic Press, in press, 1988
- Background: PubMed 2028279Johansson G, Johnson JV, Hall EM. Smoking and sedentary behavior as related to work organization. Soc Sci Med. 1991;32(7):837-46. doi: 10.1016/0277-9536(91)90310-9.
- Background: PubMed 8303487Hall EM, Johnson JV, Tsou TS. Women, occupation, and risk of cardiovascular morbidity and mortality. Occup Med. 1993 Oct-Dec;8(4):709-19.
- Background: PubMed 8465168Johnson JV, Stewart WF. Measuring work organization exposure over the life course with a job-exposure matrix. Scand J Work Environ Health. 1993 Feb;19(1):21-8. doi: 10.5271/sjweh.1508.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005212, which also lists 7 linked publications.
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 18 Feb 2016.