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

May 26, 2015 updated by: Diana J. Wilkie, University of Illinois at Chicago

Computerized PAINRelieveIt for Adult Sickle Cell Disease

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago Sickle Cell Center and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Measured at Year 2
Measured at Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

January 14, 2008

First Posted (Estimate)

January 25, 2008

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 420
  • R01HL078536 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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