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

NCT00600665 | Completed Results

• 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 (6)

• Misperception About Pain (BQ-13)

  Range 0-5. Higher score indicates more perceived barriers (greater concern about pain management beliefs and/or analgesic side effects)

  Measured at Month 3

• Composite Pain Index (CPI)

  Range 0-100. Higher score indicates worse pain.

  Measured at Month 3

• Analgesic Adherence

  Range 0-1. Higher is better.

  Measured at Month 3

• Time in Pain Crisis

  Percentage of days in pain crisis during Phase 2. Range 0-100. Lower is better.

  Measured over the course of Phase 2, a 2-year period.

• Pain Documentation

  Completeness of pain documentation during Phase 2. Range 0-100. Higher is better.

  Measured over the course of Phase 2, a two-year period.

• Appropriateness of Analgesic Prescription

  Percentage of appropriate analgesic prescriptions during Phase 2. Range 0-100. Higher is better.

  Average over the course of Phase 2, a two-year period.

Study Arms (2)

Control

ACTIVE COMPARATOR

In Phase 1 of the study, participants will access PAINReportIt and computer games. PAINReportIt helps the patient describe the pain experienced. In Phase 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 (Phase 1 + 2); Behavioral: PAINUCope (Phase 2)

Experimental

EXPERIMENTAL

In Phase 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 Phase 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 (Phase 1 + 2); Behavioral: PAINUCope (Phase 1); Behavioral: PAINConsultN (Phase 2); Behavioral: PAINUCope (Phase 2)

Interventions

PAINUCope (Phase 1) BEHAVIORAL

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

Experimental

PAINUCope (Phase 2) BEHAVIORAL

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

Control; Experimental

PAINConsultN (Phase 2) BEHAVIORAL

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

Experimental

PAINReportIt (Phase 1 + 2) BEHAVIORAL

A pain assessment data collection tool

Control; Experimental

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

Interventions

Clinical Trials, Phase I as Topic; Clinical Trials, Phase II as Topic

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

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Diana Wilkie
• Organization: University of Florida

diwilkie@ufl.edu

3522736401

Study Officials

• Diana J. Wilkie, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 4, 2026
• Results First Posted: August 4, 2026

Record last verified: 2026-07

Locations

US (1)