PINPOINT: Gaming Technology for SCD Pain

NCT04579926 | Completed Results

• 2 other identifiers: 322R44MD010746-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Sickle Cell Self-efficacy Scale Reported by Adolescents

  Sickle Cell Disease (SCD) self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain). The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD. Responses from individual items are summed to give an overall score. Higher scores indicate greater self-efficacy. Range = 0-45 (min=10 max=45).

  baseline

• Sickle Cell Self-efficacy Scale Reported by Adolescents

  Sickle Cell Disease (SCD) self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain). The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD. Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy. Range = 0-45 (min= 9; max = 45).

  4-weeks

• Sickle Cell Self-efficacy Scale Reported by Adolescents

  Sickle Cell Disease (SCD) self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain). The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD. Responses from individual items are summed to give an overall score. Higher scores indicate greater self-efficacy. Range = 0-45 (min= 24 max=45).

  8-weeks

• Sickle Cell Self-efficacy Scale Reported by Adolescents

  Sickle Cell Disease (SCD) self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain). The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD. Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy. Range = 0-45 (min=26 max=45).

  12-weeks

• Sickle Cell Self-efficacy Scale

  Sickle Cell Disease (SCD) self-efficacy: This instrument, used to assess self-efficacy in adolescents with SCD, is comprised of 9 questions measuring participants' perceptions of their ability to function on a day-to-day basis and to manage SCD symptoms (e.g., pain). The instrument is reliable and valid for assessing adolescents' self-efficacy for engaging successfully in day-to-day activities despite having SCD. Responses from individual items are summed to give an overall score, with higher scores indicating greater self-efficacy. Range = 0-45 (min=18 max=45).

  16-weeks

Secondary Outcomes (1)

• System Usability Scale (SUS)

  final posttest (either 12-weeks or 16-weeks, per stepped wedge design)

Study Arms (1)

Pinpoint App

EXPERIMENTAL

Tablet and smartphone application.

Other: Pinpoint app

Interventions

Pinpoint app OTHER

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

Pinpoint App

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Klein Buendel, Inc.: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• HPC International, Inc.: collaborator

Study Sites (2)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Hilton Publishing Company

Munster, Indiana, 463213963, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Julia Berteletti
• Organization: Klein Buendel, Inc.

jberteletti@kleinbuendel.com

3035654321

Study Officials

• Valerie Myers, PhD

  Klein Buendel, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized step wedge design with multiple baselines. Parents and adolescents were enrolled as dyads. Only adolescents received the intervention and will be reported.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 8, 2020
• Study Start: September 19, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Locations

US (2)