Clinical trial NCT04579926: PINPOINT: Gaming Technology for SCD Pain
Official title: PINPOINT: Gaming Technology to Engage Adolescent Sickle Cell Patients in Precision Pain Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Sickle Cell Anemia in Children
Sickle Cell Thalassemia
Sickle Cell SC Disease
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: HPC International, Inc.
First posted: 2020-10-08
Enrollment: 24
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Randomized step wedge design with multiple baselines. Parents and adolescents were enrolled as dyads. Only adolescents received the intervention and will be reported.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet programs to assist SCD adolescents with better identification and communication about pain are 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 self-care. Pinpoint is an interactive gaming app that will be tested in a Phase II project to determine whether the app assists SCD teens with improving their communication and identification skills for pain self-report.

Detailed description: 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 and communication of pain are lacking. In a Phase I SBIR, the investigator's team examined the feasibility and acceptability of a gamified tablet application (Pinpoint) intended to encourage teens to talk about and assess their SCD pain. The Phase I specific aims were : (1) work with an Expert Advisory Board (EAB) of experts to develop a new pain assessment tool (PAT) to engage adolescent SCD patients, improve pain specification by patients, and improve pain management by clinicians; (2) conduct cognitive interviews and focus groups with 13-17 year old SCD patients to guide and refine development of app content, design, and aesthetics to fully develop a functioning prototype; (3) conduct usability testing with 13-17 year old SCD patients to assess functionality, navigation, and satisfaction; (4) conduct cognitive interviews with medical providers to provide input on app content, perceived barriers to use, and its potential for clinical use and integration to inform future implementation; and (5) develop a specifications document to outline the Phase II development plan. Deliverables were met and feasibility was confirmed by the EAB. The proposed Phase II project will (1) develop a fully programmed, interactive Pinpoint app consisting of modules to address pain identification and communication; (2) conduct usability testing of Pinpoint to evaluate the user interface, ease of use, and perceived barriers in order to optimize the app prior to large scale evaluation (n=14); and (3) test the full app with 13-17 year olds with SCD (n=100) using a randomized step wedge design to evaluate changes in (a) knowledge acquisition for communicating about pain and types of pain; (b) the Pain Assessment; (c) SCD general knowledge and self-efficacy; (d) family cohesion; and (e) app usage. Overall, the proposed project has the potential to significantly impact the health of SCD teens by providing important skill acquisition for communicating about and identifying pain. This project is innovative and timely. Pinpoint will be the first app to identify and translate specific pain types for SCD into a gamified app using applied gamification principles.

Eligibility criteria: Inclusion Criteria:

* Be 13-17 years of age
* Be diagnosed with sickle cell disease
* Able to read and speak English
* Able to assent to participate

Exclusion Criteria:

* Not 13-17 years of age
* Not diagnosed with sickle cell disease
* Unable to read and speak English
* Unable to assent to participate

Primary outcomes:
measure: Sickle Cell Self-efficacy Scale Reported by Adolescents
timeFrame: baseline
measure: Sickle Cell Self-efficacy Scale Reported by Adolescents
timeFrame: 4-weeks
measure: Sickle Cell Self-efficacy Scale Reported by Adolescents
timeFrame: 8-weeks
measure: Sickle Cell Self-efficacy Scale Reported by Adolescents
timeFrame: 12-weeks
measure: Sickle Cell Self-efficacy Scale
timeFrame: 16-weeks
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: final posttest (either 12-weeks or 16-weeks, per stepped wedge design)
Other outcomes:
Locations:
city: Golden
country: United States
facility: Klein Buendel, Inc.
state: Colorado
city: Munster
country: United States
facility: Hilton Publishing Company
state: Indiana
Study officials:
affiliation: Klein Buendel, Inc.
name: Valerie Myers, PhD
role: PRINCIPAL_INVESTIGATOR
References: