Sickle Cell Disease
Conditions
Keywords
Sickle Cell Disease, Adolescence, Pain Assessment, Tablet Application, Pain, mHealth
Brief summary
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.
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 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.
Interventions
OTHERPinpoint App
Tablet app with pain assessment and communication education, and pain assessment tool.
Sponsors
HPC International, Inc.
National Institute on Minority Health and Health Disparities (NIMHD)
Klein Buendel, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Phone Interview, Focus Group, and Usability 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 Phone Interview, Focus Group, and Usability
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 Healthcare Provider Interview Inclusion Criteria: * Be a healthcare provider to teens with sickle cell disease * Be 18 years of age or older * Able to read and speak English * Able to consent to participate Healthcare Provider Interview
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Questionnaire | After 1-hour usability session | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pinpoint App Usability Testing Participants used the Pinpoint tablet app for one hour. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Pinpoint App Usability Testing |
|---|---|
| Age, Continuous | 14.58 years STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pinpoint App | System Usability Questionnaire | 86.67 units on a scale | Standard Deviation 11.56 |