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Gaming Technology to Engage Adolescent Sickle Cell Patients in Pain Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291613
Recruitment Status : Completed
First Posted : September 25, 2017
Results First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Collaborators:
Hilton Publishing Company
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Klein Buendel, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Pinpoint App Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: PINPOINT: Gaming Technology to Engage Adolescent Sickle Cell Patients in Precision Pain Management
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pinpoint App
Tablet application.
 Other: Pinpoint App
Tablet app with pain assessment and communication education, and pain assessment tool.


Outcome Measures
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Primary Outcome Measures :
  1. System Usability Questionnaire [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 Exclusion Criteria:

  • Not a healthcare provider to teens with sickle cell disease
  • Not 18 years of age or older
  • Unable to read and speak English
  • Unable to consent to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291613


Locations
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United States, Colorado
Klein Buendel, Inc.
Golden, Colorado, United States, 80401
United States, Indiana
Hilton Publishing Company
Munster, Indiana, United States, 463213963
Sponsors and Collaborators
Klein Buendel, Inc.
Hilton Publishing Company
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Valerie Myers, PhD Klein Buendel, Inc.
  Study Documents (Full-Text)

Documents provided by Klein Buendel, Inc.:
Study Protocol  [PDF] July 30, 2018
Statistical Analysis Plan  [PDF] July 30, 2018

More Information
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Publications:
Cope A, Darbyshire PJ. Sickle cell disease, update on management. Paediatrics and Child Health. 2013;23(11):480-485.
Mukerji I. About sickle cell disease.Sicklecellinfo.net Web site. Available at: http://www.sicklecellinfo.net/index.htm. Published 2004. Updated March 5, 2004. Accessed March 5, 2015.

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Responsible Party: Klein Buendel, Inc.
ClinicalTrials.gov Identifier: NCT03291613    
Other Study ID Numbers: 1R43MD010746-01 ( U.S. NIH Grant/Contract )
0308 ( Other Identifier: Klein Buendel, Inc. )
1R43MD010746-01 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2017    Key Record Dates
Results First Posted: February 6, 2019
Last Update Posted: February 6, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klein Buendel, Inc.:
Sickle Cell Disease
Adolescence
Pain Assessment
 Tablet Application
Pain
mHealth
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn