An interventional study of PAINReportIt (Phase 1 + 2) and PAINUCope (Phase 1) in Anemia, Sickle Cell and Hemoglobin SC Disease, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Supportive care
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.
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:
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 279 is above the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria:
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)
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)
A pain assessment data collection tool
A multimedia patient education program tailored to the participant's SCD pain management misconceptions
A decision support tool for doctors that will provide algorithm-based pain medication therapies tailored to each participant's pain level
A multimedia patient education program tailored to the participant's SCD pain management misconceptions
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)
Time frame: Measured at Month 3
Composite Pain Index (CPI)
Range 0-100. Higher score indicates worse pain.
Time frame: Measured at Month 3
Analgesic Adherence
Range 0-1. Higher is better.
Time frame: Measured at Month 3
Time in Pain Crisis
Percentage of days in pain crisis during Phase 2. Range 0-100. Lower is better.
Time frame: 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.
Time frame: 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.
Time frame: Average over the course of Phase 2, a two-year period.
| Milestone | Control | Experimental |
|---|---|---|
| Started | 124 | 116 |
| Completed baseline | 118 | 110 |
| Completed | 97 | 87 |
| Not completed | 27 | 29 |
| Milestone | Control | Experimental |
|---|---|---|
| Started | 92 | 85 |
| Completed | 92 | 85 |
| Not completed | 0 | 0 |
Range 0-5. Higher score indicates more perceived barriers (greater concern about pain management beliefs and/or analgesic side effects)
| units on a scale | Usual Care | PAINUCope/PAINConsultN |
|---|---|---|
| Misperception About Pain (BQ-13) | 2.26 ± 0.86 | 2.05 ± 0.80 |
Range 0-100. Higher score indicates worse pain.
| units on a scale | Usual Care | PAINUCope/PAINConsultN |
|---|---|---|
| Composite Pain Index (CPI) | 41.2 ± 13.7 | 43.0 ± 13.6 |
Range 0-1. Higher is better.
| percentage of pills taken | Usual Care | PAINUCope/PAINConsultN |
|---|---|---|
| Analgesic Adherence | 52 ± 68 | 45 ± 48 |
Percentage of days in pain crisis during Phase 2. Range 0-100. Lower is better.
| percentage of days | Usual Care | PAINUCope/PAINConsultN |
|---|---|---|
| Time in Pain Crisis | 7.6 ± 11.2 | 6.2 ± 11.3 |
Completeness of pain documentation during Phase 2. Range 0-100. Higher is better.
| percentage of pain doc completed | Usual Care | PAINUCope/PAINConsultN |
|---|---|---|
| Pain Documentation | 55.0 ± 11.3 | 54.3 ± 15.5 |
Percentage of appropriate analgesic prescriptions during Phase 2. Range 0-100. Higher is better.
| percentage of appropriate prescription | Usual Care | PAINUCope/PAINConsultN |
|---|---|---|
| Appropriateness of Analgesic Prescription | 72.5 ± 34.0 | 69.3 ± 36.0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | — | 0/124 (0%) | 0/124 (0%) |
| PAINUCope/PAINConsultN | — | 0/116 (0%) | 0/116 (0%) |
| Age, Continuous(years) | Control | Experimental | Total |
|---|---|---|---|
| Phase 1 | 32.7 ± 11.1 | 33.8 ± 11.2 | 33.2 ± 11.1 |
| Phase 2 | 34.0 ± 11.5 | 34.7 ± 11.5 | 34.4 ± 11.5 |
| Sex: Female, Male(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Phase 1 — Female | 77 | 65 | 142 |
| Phase 1 — Male | 41 | 45 | 86 |
| Phase 2 — Female | 61 | 51 | 112 |
| Phase 2 — Male | 31 | 34 | 65 |
| Ethnicity (NIH/OMB)(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Phase 1 — Hispanic or Latino | 3 | 4 | 7 |
| Phase 1 — Not Hispanic or Latino | 115 | 106 | 221 |
| Phase 1 — Unknown or Not Reported | 0 | 0 | 0 |
| Phase 2 — Hispanic or Latino | 4 | 1 | 5 |
| Phase 2 — Not Hispanic or Latino | 88 | 84 | 172 |
| Phase 2 — Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Control | Experimental | Total |
|---|---|---|---|
| Phase 1 — Black | 116 | 107 | 223 |
| Phase 1 — Other | 2 | 3 | 5 |
| Phase 2 — Black | 89 | 85 | 174 |
| Phase 2 — Other | 3 | 0 | 3 |
| BQ-13(units on a scale) | Control | Experimental | Total |
|---|---|---|---|
| Mean | 2.39 ± 0.92 | 2.15 ± 0.87 | 2.27 ± 0.90 |
| CPI(units on a scale) | Control | Experimental | Total |
|---|---|---|---|
| Mean | 41.8 ± 14.6 | 41.9 ± 13.7 | 41.9 ± 14.1 |
| Analgesic adherence(percentage of pills taken) | Control | Experimental | Total |
|---|---|---|---|
| Mean | 45 ± 44 | 32 ± 38 | 39 ± 42 |
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago