End stage renal disease (ESRD) is a significant and growing public health problem. However, there is limited epidemiologic data available on predictors of outcome in treated ESRD, especially as it relates to minorities and to women. We propose to study, over a five year period, all patients served by the Piedmont Dialysis Center and its satellite units, the only dialysis facilities serving a large surrounding region. The patient population is approximately 50% black, 50% female, and is socioeconomically diverse. During the course of the study, 400 prevalent and 600 incident cases will be enrolled. The inclusion of both incident and prevalent cases affords study of the effects of risk factors in both the early and late stages of treated ESRD.
The aims of the study are to : 1) describe the course and outcome of ESRD with a major emphasis on comparisons by race, gender, age and socioeconomic strata, and 2) study the effect of biomedical and psychosocial factors on ESRD outcome, including comparing different treatment modalities. The study endpoints are a) morbidity, b)mortality, and c)quality of life. An intermediate outcome is compliance with the medical regimen. All prevalent cases will be recruited and incident cases will be enrolled as they are referred for dialysis treatment. All cases will be examined every six months. Total person-years of follow-up will be at least 2,191 (follow-up will be a maximum of 3.5 years and a minimum of 1 year). Data collection will be by self- and interviewer administered questionnaires. Variables measured will include physical and mental health status, social support, and study endpoints as listed above. Medical charts and other records will be abstracted for data on medical compliance, morbidity, and causes of death. A total of 419 deaths are expected during the study period. The significance of the study rests with its potential to provide knowledge about modifiable factors that influence outcome in ESRD. Factors hypothesized to influence outcome include health status (comorbidity and disease severity), dialysis treatment modality, lipids and lipoproteins, social support and social network, dimensions of health quality of life, and compliance. The practical outcome of the study will be to apply its results to clinical trials designed to test interventions aimed at reducing the burden of ESRD.
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