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

NCT00600665 | Completed

• 2 other identifiers: 420R01HL078536
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia, Sickle Cell; Hemoglobin SC Disease

Keywords

Sickle Cell Anemia; Sickle Cell Disease

Outcome Measures

Primary Outcomes (2)

• For Part 1 of the study: misconceptions about pain, analgesic adherence, and pain intensity measured by the composite pain index (CPI)

  Measured at Month 3

• 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

  Measured at Year 2

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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 receive medial usual care at the outpatient clinic, ED, ACC, and hospital.

Behavioral: PAINReportIt; Behavioral: PAINUCope

PAINUCope/PAINConsultN

EXPERIMENTAL

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 to PAINConsultN when seen at the ED, ACC, and hospital. PAINConsultN is just-in-time decision support for the physicians with the pain data summarized and suggestions for analgesics that may be useful to help manage the patient's pain.

Behavioral: PAINReportIt; Behavioral: PAINUCope; Behavioral: PAINConsultN

Interventions

PAINReportIt BEHAVIORAL

A pain assessment data collection tool

PAINUCope/PAINConsultN; Usual Care

PAINUCope BEHAVIORAL

A multimedia patient education program tailored to the participant's SCD pain management misconceptions

PAINUCope/PAINConsultN; Usual Care

PAINConsultN BEHAVIORAL

A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level

PAINUCope/PAINConsultN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Legally blind
• Physically unable to complete study questionnaire

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Illinois at Chicago Sickle Cell Center and Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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. doi: 10.1016/s0027-9684(15)30471-5.

  PMID: 20158132 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell; Hemoglobin SC Disease

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Diana J. Wilkie, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2008
• First Posted: January 25, 2008
• Study Start: February 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)