Anemia, Sickle Cell Clinical Trial
Official title:
Pain in Sickle Cell Epidemiologic Study
To measure the variability in pain and response to pain in sickle cell disease, and to build multivariate models to explain both patients' pain and their response to pain, especially, utilization of health care.
BACKGROUND:
Pain in sickle cell disease is poorly recognized, measured, and treated. Although painful
episodes are the most common reason sickle cell patients seek care, studies have seldom
directly measured pain in detail. In studies to date, biological and demographic variables
alone only partly explain the observed variance in painful episode frequency. Further,
little is known about differences in pain responses including home management versus health
care utilization.
DESIGN NARRATIVE:
This cohort study is measuring the variability in pain and response to pain in sickle cell
disease, and building multivariate models to explain both patients' pain and their response
to pain, especially, utilization of health care. The models' outcome variables include mean
pain, painful episodes, and various types of utilization episodes, including non-narcotic
analgesic use, narcotic use, office visits, emergency department (ED visits, and
hospitalization. An additional outcome is the percentage of each patient's painful episodes
that result in various types of utilization. Outcomes will be operationalized using daily
pain diaries collected over six months. Reflecting on the prior 24 hours, patients will
recall on an ordinal (0-9) scale maximum pain, distress, and disability, judge whether they
were in a "crisis," and note pain locations and their various types of utilization. Daily
pain intensity ratings will be transformed into pain episode counts using a formulaic
threshold for a painful episode. The formula calculates each patient's threshold
individually, based on his/her pain ratings. The models will measure the effect of several
classes of explanatory variables (demographic, disease-related, psycho social, and readiness
to utilize care), operationalized using primary data and validated instruments.
Patients will be recruited from the central and Tidewater regions of Virginia, will undergo
an initial survey battery, chart review, and a brief final survey, venipuncture and urine
sampling, and complete pain diaries daily for six months. This study will advance knowledge
of the etiology and influences on pain and pain response in sickle cell disease. By
revealing potentially mutable explanatory variables, the study's results will suggest
targets of biobehavioral treatment interventions.
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