PINPOINT: Gaming Technology for SCD Pain

NCT ID: NCT04579926

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2022-06-30

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.

Conditions

Sickle Cell Disease; Sickle Cell Anemia in Children; Sickle Cell Thalassemia; Sickle Cell SC Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pinpoint App

Tablet and smartphone application.

Group Type: EXPERIMENTAL

Pinpoint app

Intervention Type: OTHER

Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.

Interventions

Pinpoint app

Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

HPC International, Inc.

INDUSTRY

Sponsor Role: collaborator

Klein Buendel, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerie Myers, PhD

Role: PRINCIPAL_INVESTIGATOR

Klein Buendel, Inc.

Locations

Klein Buendel, Inc.

Golden, Colorado, United States

Hilton Publishing Company

Munster, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R44MD010746-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

322

Identifier Type: -

Identifier Source: org_study_id