Blood DiseaseNCT00035763
Pain in Sickle Cell Epidemiologic Study
An observational study of Blood Disease and Anemia, Sickle Cell, run by Virginia Commonwealth University.
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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Blood Disease, Anemia, Sickle Cell
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2001to Aug 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this 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.
Read the 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.
- Conditions
- Blood Disease, Anemia, Sickle Cell
- Medical subject headings
- Hematologic Diseases, Anemia, Sickle Cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2002 (estimated)
- Study startOct 2001
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood DiseaseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Wally Smith, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00035763
- Sponsor's protocol ID
- 1105
- Other IDs
- R01HL064122
- Status last verified
- Jan 2008
- First submitted
- 4 May 2002
- Last updated
- 24 Mar 2016
- Results posted
- No
Publications
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.
PubMed 15712781
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in Sickle Cell Epidemiologic Study
- ClinicalTrials.gov ID
- NCT00035763
- Acronym / sponsor ID
- 1105
- Conditions
- Blood Disease, Anemia, Sickle Cell
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2001
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 6 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Background: PubMed 15712781Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wally Smith
Virginia Commonwealth University
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Disease and Anemia, Sickle Cell, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00035763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.