Expired Study
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Chicago, Illinois 60612


Purpose:

Sickle cell disease (SCD) is a blood disorder that is characterized by intense, painful episodes known as sickle cell crises. This study will evaluate the effectiveness of PAINRelieveIt, a three-part computer-based pain management tool, in treating adults with SCD.


Study summary:

SCD is an inherited blood disorder that mainly affects people of African, Mediterranean, or Latin descent. Symptoms include anemia, infections, organ damage, and painful sickle cell crises. Adults with SCD who experience frequent painful crises are more likely to die sooner than are adults with SCD who have fewer painful crises. Experts suggest that SCD pain be treated in the same way that cancer pain is treated because both types of pain are sustained and severe. However, unlike the research directed towards cancer pain, research focused on the characteristics of SCD pain has been limited. Although medications are available to treat SCD pain, the SCD pain management process is complex and often requires more time than what is available during the typical medical appointment. Recent advances in computer technologies may provide an opportunity to improve the effectiveness of SCD pain management by combining online patient education with decision-making support tools for doctors. This study will evaluate three touch screen computerized tools that are known collectively as PAINRelieveIt. The three tools include the following: 1. PAINReportIt—a pain assessment data collection tool 2. PAINUCope—a multimedia patient education program tailored to the participant's SCD pain management misconceptions 3. PAINConsultN—a decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level This two-part study will evaluate the effectiveness of PAINReportIt and PAINUCope, alone and in combination with PAINConsultN, at improving participants' SCD pain by educating participants about their role in pain management and by providing decision-making support to doctors. This study comprises two parts. Part 1 of the study will enroll patients who are receiving care at the University of Illinois at Chicago Sickle Cell Clinic. The patients will be randomly assigned to receive 3 months of either access to PAINReportIt and PAINUCope or usual care. At baseline and Month 3, participants will complete questionnaires on misconceptions about pain, medication adherence, and pain intensity. The same participants from Part 1 of the study will be enrolled into Part 2 of the study, which will last 2 years. Part 2 participants will be randomly assigned to receive either care from doctors who have access to PAINConsultN or usual care. All participants will have access to PAINReportIt and PAINUCope. At baseline and Year 2, participants will complete questionnaires on pain episodes. Information will also be collected from doctors, including pain documentation, appropriateness of prescribed pain medications, and the number of emergency department visits by and hospitalizations of participants experiencing painful SCD crises.


Criteria:

Inclusion Criteria: - Diagnosed with SCD - Scheduled for continuing care at the University of Illinois at Chicago Sickle Cell Clinic - Experienced a moderate to severe level of pain (at least 3 on 0 to 10 scale) related to the SCD within the 12 months prior to study entry - Had a emergency department visit or hospitalization within the 2 years prior to study entry - Speaks and reads English Exclusion Criteria: - Legally blind - Physically unable to complete study questionnaire


Study is Available At:


Original ID:

420


NCT ID:

NCT00600665


Secondary ID:

R01HL078536


Study Acronym:


Brief Title:

Effectiveness of a Computerized Tool (PAINRelieveIt) to Help Manage Pain Related to Sickle Cell Disease


Official Title:

Computerized PAINRelieveIt for Adult Sickle Cell Disease


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Illinois at Chicago


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

279


Enrollment Type:

Actual


Overall Contact Information

Official Name:Diana J. Wilkie, PhD
Principal Investigator
University of Illinois at Chicago

Study Dates

Start Date:February 2007
Completion Date:June 2014
Completion Type:Actual
Primary Completion Date:June 2013
Primary Completion Type:Actual
Verification Date:May 2015
Last Changed Date:May 26, 2015
First Received Date:January 14, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:For Part 2 of the study: number of participant-reported pain episodes, pain documentation and appropriateness of prescribed analgesics as measured by doctors, and number of emergency department visits and hospitalizations
Time Frame:Measured at Year 2
Safety Issues:False
Outcome Type:Primary Outcome
Measure:For Part 1 of the study: misconceptions about pain, analgesic adherence, and pain intensity measured by the composite pain index (CPI)
Time Frame:Measured at Month 3
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:PAINReportIt
Description:A pain assessment data collection tool
Arm Name:Usual Care
Intervention Type:Behavioral
Name:PAINUCope
Description:A multimedia patient education program tailored to the participant's SCD pain management misconceptions
Arm Name:Usual Care
Intervention Type:Behavioral
Name:PAINConsultN
Description:A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
Arm Name:PAINUCope/PAINConsultN

Study Arms

Study Arm Type:Active Comparator
Arm Name:Usual Care
Description:In Part 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Part 2 of the study, participants will continue to access PAINReportIt when they are seen in the clinic, emergency department (ED), acute care center (ACCA), and hospital. They will gain access to the PAINUCope computer-based programs, which provides multimedia education tailored to the patient's misconceptions about pain management. They will recei
Study Arm Type:Experimental
Arm Name:PAINUCope/PAINConsultN
Description:In Part 1 of the study, participants will access PAINReportIt and PAINUCope computer-based programs. PAINReportIt helps the patients describe the pain experiences and PAINUCope provides multimedia education tailored to the patient's misconceptions about pain management. In Part 2 of the study, participants will continue to access PAINReportIt and PAINUCope programs when they are seen in the clinic, emergency department (ED), acute care center (ACC), and hospital. Their doctors will have access t

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Illinois at Chicago
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Wilkie DJ, Molokie R, Boyd-Seal D, Suarez ML, Kim YO, Zong S, Wittert H, Zhao Z, Saunthararajah Y, Wang ZJ. Patient-reported outcomes: descriptors of nociceptive and neuropathic pain and barriers to effective pain management in adult outpatients with sickle cell disease. J Natl Med Assoc. 2010 Jan;102(1):18-27.
PMID:20158132

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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