Anemia, Sickle CellNCT00600665
Effectiveness of a Computerized Tool (PAINRelieveIt) to Help Manage Pain Related to Sickle Cell Disease
A study testing PAINReportIt (Phase 1 + 2), PAINUCope (Phase 1) and PAINConsultN (Phase 2) in people with Anemia, Sickle Cell and Hemoglobin SC Disease, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Sickle Cell, Hemoglobin SC Disease
- What is being tested?
- PAINReportIt (Phase 1 + 2), PAINUCope (Phase 1) and PAINConsultN (Phase 2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Legally blind
- Physically unable to complete study questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Sickle Cell Center and Medical Center
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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:
- PAINReportIt-a pain assessment data collection tool
- PAINUCope-a multimedia patient education program tailored to the participant's SCD pain management misconceptions
- 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 will enroll patients who are receiving care at the University of Illinois at Chicago Sickle Cell Clinic. The patients will be randomly assigned to either the experimental group or the control group. It comprises two phases. In Phase 1, the patients in the experimental group will have access to PAINReportIt and PAINUCope, which the control will have access to PAINReportIt and a selection of games. At baseline and Month 3, participants will complete questionnaires on misconceptions about pain, medication adherence, and pain intensity. The same participants from Phase 1 of the study will be enrolled into Phase 2 of the study with the same group assignment, which will last 2 years. In Phase 2, the experimental group participants will be assigned to receive care from doctors who have access to PAINConsultN while the control group will be assigned to usual care. All participants will have access to PAINReportIt and PAINUCope in Phase 2. 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.
- Conditions
- Anemia, Sickle Cell, Hemoglobin SC Disease
- Being tested
- PAINReportIt (Phase 1 + 2), PAINUCope (Phase 1), PAINConsultN (Phase 2), PAINUCope (Phase 2)
- Keywords
- Sickle Cell Anemia, Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell, Hemoglobin SC Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAINReportIt (Phase 1 + 2)Behavioural
A pain assessment data collection tool
PAINUCope (Phase 1)Behavioural
A multimedia patient education program tailored to the participant's SCD pain management misconceptions
PAINConsultN (Phase 2)Behavioural
A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
PAINUCope (Phase 2)Behavioural
A multimedia patient education program tailored to the participant's SCD pain management misconceptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PAINReportIt (Phase 1 + 2); Behavioral: PAINUCope (Phase 1); Behavioral: PAINConsultN (Phase 2); Behavioral: PAINUCope (Phase 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Month 3
Composite Pain Index (CPI)
Range 0-100. Higher score indicates worse pain.
Measured: Measured at Month 3
Analgesic Adherence
Range 0-1. Higher is better.
Measured: Measured at Month 3
Time in Pain Crisis
Percentage of days in pain crisis during Phase 2. Range 0-100. Lower is better.
Measured: 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: 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.
Measured: Average over the course of Phase 2, a two-year period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Diana J. Wilkie, University of Illinois Chicago
- Investigators
- Diana J. Wilkie, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600665
- Sponsor's protocol ID
- 420
- Other IDs
- R01HL078536
- Status last verified
- Jul 2026
- First submitted
- 14 Jan 2008
- Last updated
- 4 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20158132
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized PAINRelieveIt for Adult Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00600665
- Acronym / sponsor ID
- 420
- Conditions
- Anemia, Sickle Cell, Hemoglobin SC Disease
- Keywords
- Sickle Cell Anemia, Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Posted 4 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- PAINReportIt-a pain assessment data collection tool
- PAINUCope-a multimedia patient education program tailored to the participant's SCD pain management misconceptions
- 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 will enroll patients who are receiving care at the University of Illinois at Chicago Sickle Cell Clinic. The patients will be randomly assigned to either the experimental group or the control group. It comprises two phases. In Phase 1, the patients in the experimental group will have access to PAINReportIt and PAINUCope, which the control will have access to PAINReportIt and a selection of games. At baseline and Month 3, participants will complete questionnaires on misconceptions about pain, medication adherence, and pain intensity. The same participants from Phase 1 of the study will be enrolled into Phase 2 of the study with the same group assignment, which will last 2 years. In Phase 2, the experimental group participants will be assigned to receive care from doctors who have access to PAINConsultN while the control group will be assigned to usual care. All participants will have access to PAINReportIt and PAINUCope in Phase 2. 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: PAINReportIt (Phase 1 + 2), Behavioral: PAINUCope (Phase 2)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. |
| Experimental | Experimental | Behavioral: PAINReportIt (Phase 1 + 2), Behavioral: PAINUCope (Phase 1), Behavioral: PAINConsultN (Phase 2), Behavioral: PAINUCope (Phase 2)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Legally blind
- Physically unable to complete study questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAINReportIt (Phase 1 + 2)A pain assessment data collection tool | Behavioural | Control, Experimental |
| PAINUCope (Phase 1)A multimedia patient education program tailored to the participant's SCD pain management misconceptions | Behavioural | Experimental |
| PAINConsultN (Phase 2)A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level | Behavioural | Experimental |
| PAINUCope (Phase 2)A multimedia patient education program tailored to the participant's SCD pain management misconceptions | Behavioural | Control, Experimental |
Primary outcome
Misperception About Pain (BQ-13)
Time frame: Measured at Month 3
Range 0-5. Higher score indicates more perceived barriers (greater concern about pain management beliefs and/or analgesic side effects)
Composite Pain Index (CPI)
Time frame: Measured at Month 3
Range 0-100. Higher score indicates worse pain.
Analgesic Adherence
Time frame: Measured at Month 3
Range 0-1. Higher is better.
Time in Pain Crisis
Time frame: Measured over the course of Phase 2, a 2-year period.
Percentage of days in pain crisis during Phase 2. Range 0-100. Lower is better.
Pain Documentation
Time frame: Measured over the course of Phase 2, a two-year period.
Completeness of pain documentation during Phase 2. Range 0-100. Higher is better.
Appropriateness of Analgesic Prescription
Time frame: Average over the course of Phase 2, a two-year period.
Percentage of appropriate analgesic prescriptions during Phase 2. Range 0-100. Higher is better.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20158132Wilkie 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.
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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.
Diana J. Wilkie, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAINReportIt (Phase 1 + 2), PAINUCope (Phase 1) and PAINConsultN (Phase 2) in people with Anemia, Sickle Cell and Hemoglobin SC Disease, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 4 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Misperception About Pain (BQ-13) (time frame: Measured at Month 3). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600665, 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 4 Aug 2026.