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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00035763
Other study ID # 1105
Secondary ID R01HL064122
Status Completed
Phase N/A
First received May 4, 2002
Last updated March 23, 2016
Start date October 2001
Est. completion date August 2006

Study information

Verified date January 2008
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 2006
Est. primary completion date August 2006
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Smith WR, Bovbjerg VE, Penberthy LT, McClish DK, Levenson JL, Roberts JD, Gil K, Roseff SD, Aisiku IP. Understanding pain and improving management of sickle cell disease: the PiSCES study. J Natl Med Assoc. 2005 Feb;97(2):183-93. — View Citation

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