Cardiovascular DiseasesNCT00005420
Prediction of Quality of Life in Cardiovascular Disease
An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by University of Texas at Austin.
Trial summary
To develop an integrative predictive model of long-term quality of life in cardiovascular disease that emphasized adaptive processes and outcomes. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Cerebrovascular Accident, Hypertension
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1992to Mar 1995
- 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 develop an integrative predictive model of long-term quality of life in cardiovascular disease that emphasized adaptive processes and outcomes.
Read the detailed description
BACKGROUND:
Modern treatments for cardiovascular disease that enhance survival have increased the need to understand and improve corresponding aspects of quality of life. The increasing interest in prevention and health promotion in contemporary cardiovascular care emphasizes reducing risk factors that have major behavioral components, such as smoking, diet, and exercise. Personal and social resources and psychological coping strategies are associated with quality of life both directly and indirectly, through such positive health behaviors. Findings from this research provided an essential foundation for continued investigation focusing on longer-term changes in health status and quality of life in a planned ten-year follow-up with the present sample.
DESIGN NARRATIVE:
The study developed and tested an integrative prospective structural equation model of the interrelationships among social resources, coping strategies, positive health behaviors, and quality of life in cardiovascular disease over a four-year time-period. It also contrasted predictive findings relating to cardiac illness, stroke, and hypertension with predictive findings from matched-control groups of healthy individuals and individuals with very serious (cancer) and moderately serious (arthritis) noncardiovascular disease.
The research involved secondary data analysis with a large sample of individuals surveyed through the Center for Health Care Evaluation at the Stanford University Medical School. The sample included individuals between the ages of 55 and 65 who had used medical services in two large medical centers. Extensive psychosocial and physical health data were available from mail-out inventories at three points in time over a four- year period. Of eligible respondents contacts, 92 percent agreed to participate in the initial survey, and 89 percent (1884) of them provided complete data. Participation in one-year and four-year follow-ups approached 90 percent of surviving respondents from the previous survey. At the initial testing, 411 respondents (22 percent) reported diagnosed cardiac illness (excluding stroke and hypertension), 83 respondents (5 percent) reported diagnosed strokes, and 593 respondents (31 percent) reported diagnosed hypertension.
The data base at all three measurement times included extensive information on the quality of life, positive health behaviors, personal and social resources, and coping strategies. Computerized hospital medical records were available for one-third of the sample, and were used to evaluate the reliability of subjects' self-reports of medical conditions and health status. Group comparisons were made on two dimensions: illness type and post-illness time interval. Longitudinal analyses were used to examine causal influences on positive health behaviors and quality of life, and to develop and test an integrative predictive model.
- Conditions
- Cardiovascular Diseases, Cerebrovascular Accident, Hypertension, Depression, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Stroke, Hypertension, Depression, 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 startApr 1992
- Study completionMar 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University of Texas at AustinThe 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
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005420
- Sponsor's protocol ID
- 4338
- Other IDs
- R03HL048063
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 14 Jan 2016
- Results posted
- No
Publications
Holahan CJ, Moos RH, Holahan CK, Brennan PL. Social context, coping strategies, and depressive symptoms: an expanded model with cardiac patients. J Pers Soc Psychol. 1997 Apr;72(4):918-28. doi: 10.1037//0022-3514.72.4.918.
PubMed 9108704Holahan CJ, Moos RH, Holahan CK, Brennan PL. Social support, coping, and depressive symptoms in a late-middle-aged sample of patients reporting cardiac illness. Health Psychol. 1995 Mar;14(2):152-63. doi: 10.1037//0278-6133.14.2.152.
PubMed 7789351
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Quality of Life in Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00005420
- Acronym / sponsor ID
- 4338
- Conditions
- Cardiovascular Diseases, Cerebrovascular Accident, Hypertension, Depression, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1992
- Study completion
- Mar 1995
- 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 develop an integrative predictive model of long-term quality of life in cardiovascular disease that emphasized adaptive processes and outcomes.
Detailed description
BACKGROUND:
Modern treatments for cardiovascular disease that enhance survival have increased the need to understand and improve corresponding aspects of quality of life. The increasing interest in prevention and health promotion in contemporary cardiovascular care emphasizes reducing risk factors that have major behavioral components, such as smoking, diet, and exercise. Personal and social resources and psychological coping strategies are associated with quality of life both directly and indirectly, through such positive health behaviors. Findings from this research provided an essential foundation for continued investigation focusing on longer-term changes in health status and quality of life in a planned ten-year follow-up with the present sample.
DESIGN NARRATIVE:
The study developed and tested an integrative prospective structural equation model of the interrelationships among social resources, coping strategies, positive health behaviors, and quality of life in cardiovascular disease over a four-year time-period. It also contrasted predictive findings relating to cardiac illness, stroke, and hypertension with predictive findings from matched-control groups of healthy individuals and individuals with very serious (cancer) and moderately serious (arthritis) noncardiovascular disease.
The research involved secondary data analysis with a large sample of individuals surveyed through the Center for Health Care Evaluation at the Stanford University Medical School. The sample included individuals between the ages of 55 and 65 who had used medical services in two large medical centers. Extensive psychosocial and physical health data were available from mail-out inventories at three points in time over a four- year period. Of eligible respondents contacts, 92 percent agreed to participate in the initial survey, and 89 percent (1884) of them provided complete data. Participation in one-year and four-year follow-ups approached 90 percent of surviving respondents from the previous survey. At the initial testing, 411 respondents (22 percent) reported diagnosed cardiac illness (excluding stroke and hypertension), 83 respondents (5 percent) reported diagnosed strokes, and 593 respondents (31 percent) reported diagnosed hypertension.
The data base at all three measurement times included extensive information on the quality of life, positive health behaviors, personal and social resources, and coping strategies. Computerized hospital medical records were available for one-third of the sample, and were used to evaluate the reliability of subjects' self-reports of medical conditions and health status. Group comparisons were made on two dimensions: illness type and post-illness time interval. Longitudinal analyses were used to examine causal influences on positive health behaviors and quality of life, and to develop and test an integrative predictive model.
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 14 Jan 2016.
- Background: PubMed 9108704Holahan CJ, Moos RH, Holahan CK, Brennan PL. Social context, coping strategies, and depressive symptoms: an expanded model with cardiac patients. J Pers Soc Psychol. 1997 Apr;72(4):918-28. doi: 10.1037//0022-3514.72.4.918.
- Background: PubMed 7789351Holahan CJ, Moos RH, Holahan CK, Brennan PL. Social support, coping, and depressive symptoms in a late-middle-aged sample of patients reporting cardiac illness. Health Psychol. 1995 Mar;14(2):152-63. doi: 10.1037//0278-6133.14.2.152.
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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.
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 Cerebrovascular Accident, run by University of Texas at Austin.
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 14 Jan 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 NCT00005420, which also lists 2 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 14 Jan 2016.