Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035763
Status:
COMPLETED
Last Update Posted:
2016-03-24
First Post:
2002-05-04
Brief Title:
Pain in Sickle Cell Epidemiologic Study
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Pain in Sickle Cell Epidemiologic Study
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients 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 patients threshold individually based on hisher 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 studys results will suggest targets of biobehavioral treatment interventions
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 patients 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 patients threshold individually based on hisher 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 studys results will suggest targets of biobehavioral treatment interventions
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL064122 | NIH | None | httpsreporternihgovquickSearchR01HL064122 |