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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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

Other trials in United States

About this study

Official title: Computerized PAINRelieveIt for Adult Sickle Cell Disease

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 groups in NCT00600665
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.

Feb 2007Jun 2014

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
Sickle Cell Disease (SCD), Vaso-Occlusive Pain Episode in Sickle Cell Disease
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis

All Anemia, Sickle Cell trials

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.

Detailed description

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

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

Results posted to the registry on 4 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	124	97
Experimental	116	87

Primary outcome: Misperception About Pain (BQ-13)

Time frame: Measured at Month 3. Mean (Standard Deviation). Unit: units on a scale

Measure	Usual Care n = 118	PAINUCope/PAINConsultN n = 110
Value	2.26 (0.86)	2.05 (0.80)

Usual Care vs PAINUCope/PAINConsultN: Mean Difference (Net): -0.097, p = 0.35, Regression, Linear

Population analysed: The analysis included all participants that completed the baseline. Multiple imputation was used for missing data processing. This is a Phase 1 only outcome measure.

Primary outcome: Composite Pain Index (CPI)

Time frame: Measured at Month 3. Mean (Standard Deviation). Unit: units on a scale

Measure	Usual Care n = 118	PAINUCope/PAINConsultN n = 110
Value	41.2 (13.7)	43.0 (13.6)

Usual Care vs PAINUCope/PAINConsultN: Mean Difference (Net): 1.763, p = 0.36, Regression, Linear

Population analysed: The analysis included all participants that completed the baseline. Multiple imputation was used for missing data processing. This is a Phase 1 only outcome measure.

Primary outcome: Analgesic Adherence

Time frame: Measured at Month 3. Mean (Standard Deviation). Unit: percentage of pills taken

Measure	Usual Care n = 118	PAINUCope/PAINConsultN n = 110
Value	52 (68)	45 (48)

Usual Care vs PAINUCope/PAINConsultN: Mean Difference (Net): -3.8, p = 0.68, Regression, Linear

Population analysed: The analysis included all participants that completed the baseline. Multiple imputation was used for missing data processing. Collected in Phase 1 only.

Primary outcome: Time in Pain Crisis

Time frame: Measured over the course of Phase 2, a 2-year period.. Mean (Standard Deviation). Unit: percentage of days

Measure	Usual Care n = 92	PAINUCope/PAINConsultN n = 85
Value	7.6 (11.2)	6.2 (11.3)

Usual Care vs PAINUCope/PAINConsultN: Mean Difference (Net): -0.014, p = 0.41, Regression, Linear

Population analysed: Patients that participated in Phase 2. This is a Phase 2 only outcome measure.

Adverse events

Time frame: For subjects that participated in Phase 1 but not Phase 2, through the end of Phase 1, an average of 3 months. For subjects that participated in both Phase 1 and Phase 2, through study completion, an average of 2 years and 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 124 (0%)	0 of 124 (0%)	Not reported
PAINUCope/PAINConsultN	0 of 116 (0%)	0 of 116 (0%)	Not reported

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.

Related trials for Anemia, Sickle Cell

Active, not recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
Sickle Cell Disease, Hemolytic Anemia
RecruitingObservational study
HPC Offered for PRESERVE Expansion
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RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
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RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
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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?

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.