Pain in Sickle Cell Epidemiologic Study

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00035763
First received: May 4, 2002
Last updated: January 18, 2008
Last verified: January 2008
  Purpose

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.


Condition
Blood Disease
Anemia, Sickle Cell

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: October 2001
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00035763

Sponsors and Collaborators
Investigators
Investigator: Wally Smith Virginia Commonwealth University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00035763     History of Changes
Other Study ID Numbers: 1105
Study First Received: May 4, 2002
Last Updated: January 18, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014