Trial Outcomes & Findings for PINPOINT: Gaming Technology for SCD Pain (NCT NCT04579926)

Last Updated: 2024-05-01

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

baseline

Results posted on

2024-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Pinpoint App Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool. Parent-adolescent dyads were randomized, but only adolescents received the intervention and were assessed for outcome measures.
Overall Study STARTED	24
Overall Study Parents	24
Overall Study Adolescents	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PINPOINT: Gaming Technology for SCD Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pinpoint App n=24 Participants Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
Age, Categorical <=18 years	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14.75 years STANDARD_DEVIATION 1.62 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Population: adolescents

Outcome measures

Outcome measures
Measure	Pinpoint App n=24 Participants Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
Sickle Cell Self-efficacy Scale Reported by Adolescents	34.6 units on a scale Standard Deviation 8.3

PRIMARY outcome

Timeframe: 4-weeks

Population: 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).

Outcome measures

Outcome measures
Measure	Pinpoint App n=24 Participants Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
Sickle Cell Self-efficacy Scale Reported by Adolescents	35.8 units on a scale Standard Deviation 8.3

PRIMARY outcome

Timeframe: 8-weeks

Population: adolescents

Outcome measures

Outcome measures
Measure	Pinpoint App n=24 Participants Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
Sickle Cell Self-efficacy Scale Reported by Adolescents	37.4 units on a scale Standard Deviation 5.9

PRIMARY outcome

Timeframe: 12-weeks

Population: 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).

Outcome measures

Outcome measures
Measure	Pinpoint App n=24 Participants Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
Sickle Cell Self-efficacy Scale Reported by Adolescents	38.9 units on a scale Standard Deviation 6.5

PRIMARY outcome

Timeframe: 16-weeks

Population: adolescents eligible from stepped wedge design

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).

Outcome measures

Outcome measures
Measure	Pinpoint App n=6 Participants Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
Sickle Cell Self-efficacy Scale	39.0 units on a scale Standard Deviation 10.5

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Pinpoint App n=23 Participants Tablet and smartphone application. Pinpoint app: Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
System Usability Scale (SUS)	72.5 units on a scale Standard Deviation 19.1

Adverse Events

Pinpoint App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julia Berteletti

Klein Buendel, Inc.

Phone: 3035654321

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place