Sickle Cell Disease Clinical Trial
— Pinpoint IIOfficial title:
PINPOINT: Gaming Technology to Engage Adolescent Sickle Cell Patients in Precision Pain Phase II
Verified date | April 2024 |
Source | Klein Buendel, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 30, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Klein Buendel, Inc. | Golden | Colorado |
United States | Hilton Publishing Company | Munster | Indiana |
Lead Sponsor | Collaborator |
---|---|
Klein Buendel, Inc. | Hilton Publishing Company, National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | System Usability Scale (SUS) | Technology acceptability: The System Usability Scale (SUS) is a reliable tool for measuring the usability of technologies. It consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average. Range = 37.5-100 | final posttest (either 12-weeks or 16-weeks, per stepped wedge design) |
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