An interventional study of Pinpoint App in Sickle Cell Disease, sponsored by Klein Buendel, Inc.. Completed at 2 sites in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-06.
Sponsored by Klein Buendel, Inc. · Not applicable, Interventional, and Supportive care
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Among 733 studies in Anemia, Sickle Cell with a site in United States — 134 open to participants now, 185 under way, 16 of them phase 3. Anemia, Sickle Cell · United States.
Among the 733 studies in Anemia, Sickle Cell with a site in United States, this one is the 422nd largest by enrollment of the 559 interventional ones that give a count, is one of 33 that started in 2017, is one of 165 with no phase, and was the 387th registered.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
Browse Anemia, Sickle Cell studies →134 of the 733 studies in Anemia, Sickle Cell with a site in United States are open now. Recruiting first, the newest first:
University of Maryland, Baltimore · Sites in United States
Ages 18–88
Mohsen Saidinejad · Sites in United States
Ages 5–20
St. Jude Children's Research Hospital · Sites in United States
Ages up to 22
Emory University · Sites in United States
Ages 8–18
University of Alabama at Birmingham · Sites in United States
Ages 18–50 · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 177 Anemia, Sickle Cell studies recruiting now, 64 (36%) set no upper age limit and 97 (55%) stop at 75 or younger; 127 take children under 18; 29 take healthy volunteers.
This study: 13 Years and older · all sexes · healthy volunteers too.
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733 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 158 · Phase 2 228 · Phase 3 57 · Phase 4 20
First in 1984; this study’s year is marked. 33 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 13 is below the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Median enrollment 31 across the 559 interventional studies, 100 across the 168 observational. Of the 506 that completed or were terminated, 207 (41%) have results posted.
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168 of 733 have an industry lead sponsor. The 10 most frequent:
Klein Buendel, Inc. is the lead sponsor of 35 studies on the registry; 2 are open to participants now.
Klein Buendel, Inc. has 2 studies filed under Anemia, Sickle Cell — fewer than ten, so there is no comparison to draw.
57 of the studies in Anemia, Sickle Cell with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07247188Phase 3SanofiStudy of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease | 2027-01-07 |
| NCT04293185Phase 3bluebird bioA Study Evaluating Gene Therapy With BB305 Lentiviral Vector in Sickle Cell Disease | 2027-05 |
| NCT06989567Phase 3Asklepion Pharmaceuticals, LLCA Study of Intravenous L-Citrulline in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting to Emergency Departments in Acute Vaso-Occlusive Crisis | 2027-06 |
| NCT05329649Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Safety and Efficacy of CTX001 in Pediatric Participants With Severe Sickle Cell Disease (SCD) | 2027-06-06 |
| NCT05477563Phase 3Vertex Pharmaceuticals IncorporatedEvaluation of Efficacy and Safety of a Single Dose of CTX001 in Participants With Transfusion-Dependent β-Thalassemia and Severe Sickle Cell Disease | 2027-06-09 |
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Among the 733 studies in Anemia, Sickle Cell with a site in United States, from their registry updates:
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Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet assessments to identify type, intensity, frequency, and phase of pain among SCD adolescents is lacking. Research shows that interactive gaming technology can enhance adolescents' learning, and can be especially effective in delivering health-related messages and tools to improve their self-care. Pinpoint is an interactive gaming tablet app that will be developed with the significant input of clinical experts to assist SCD teens with better identification and self-report of their pain.
Sickle cell disease (SCD) is the most common inherited blood disorder in the U.S. and disproportionately affects African Americans and Hispanics. Approximately, 1,000 U.S. children are born with SCD annually. SCD results from abnormal hemoglobin and causes red blood cells (RBCs) to become misshaped ("sickle-shaped"). Sickled cells can block the flow of blood in small arteries causing tissue and organ damage and other life-threatening comorbidities. SCD complications can be serious and have a significant impact upon well-being and quality of life. Pain is the hallmark symptom associated with SCD, and is the most common clinical problem seen in children and the number one cause of SCD-related hospital admissions. If left untreated, these painful episodes can result in morbidity and mortality. Accurate assessment of pain specifiers (type, frequency, and intensity of pain) can help with ameliorating pain quickly and effectively. Despite children being accurate self-reporters of their pain, strategies which are effective and engaging to assist with pain identification are lacking. Reducing barriers to collection and promoting the value of accurate SCD pain assessment is a need in pediatric medicine. Pinpoint will be an innovative interactive assessment tool that engages patients while allowing physicians to collect important health data. This project will test the feasibility of applying gamification principles to develop a tablet application ("app") for 13-17 year olds with SCD. Specifically, this Phase I SBIR project will (1) develop a Pain Assessment Tool (PAT) to describe and categorize specific types of pain experienced by adolescents with SCD; and (2) create an app ("Pinpoint"), that will translate the PAT into gamified technology. The goal of Pinpoint is to engage adolescent patients and improve pain specification by developing a game-based pain assessment tool delivered via a tablet app to engage adolescent SCD patients, improve their pain specification self-report, and improve pain management by clinicians. The PAT will be developed using expert guidance from preeminent SCD clinicians. User-centered Design theory will be applied in the development of the app and will be guided by iterative cognitive interviews and focus groups with members of the target population, SCD teens. The project specific aims are to (1) develop the PAT using guidance from an Expert Advisory Board (EAB) of SCD clinicians; (2) conduct a series of cognitive interviews with adolescent SCD patients to guide and refine PAT development; (3) conduct iterative focus groups with adolescent SCD patients to guide and refine user interface design of the Pinpoint app; (4) program a functional Pinpoint prototype; and (5) conduct usability testing of the prototype with 13-17 year old SCD patients to assess functionality, navigation, and satisfaction. This project is innovative and timely. Pinpoint will be the first tablet app to identify and translate specific pain types for SCD into a gamified app using applied gamification principles.
Phone Interview, Focus Group, and Usability Inclusion Criteria:
Phone Interview, Focus Group, and Usability Exclusion Criteria:
Healthcare Provider Interview Inclusion Criteria:
Healthcare Provider Interview Exclusion Criteria:
Tablet application.
Other: Pinpoint App
Tablet app with pain assessment and communication education, and pain assessment tool.
System Usability Questionnaire
Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
Time frame: After 1-hour usability session
| Milestone | Pinpoint App Usability Testing |
|---|---|
| Started | 13 |
| Completed | 12 |
| Not completed | 1 |
Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
| units on a scale | Pinpoint App |
|---|---|
| System Usability Questionnaire | 86.67 ± 11.56 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pinpoint App | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Pinpoint App Usability Testing |
|---|---|
| Mean | 14.58 ± 1.00 |
| Sex: Female, Male(Participants) | Pinpoint App Usability Testing |
|---|---|
| Female | 5 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Pinpoint App Usability Testing |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 0 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Pinpoint App Usability Testing |
|---|---|
| United States | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jan 2017 to primary completion in Sep 2017, 8 months.
Results were first posted in Feb 2019, 1 year 4 months after primary completion.
Of 173 interventional studies with no phase under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 49. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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