Gaming Technology to Engage Adolescent Sickle Cell Patients in Pain Management

• 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: Klein Buendel, Inc.
• Collaborators: Hilton Publishing Company; National Institute on Minority Health and Health Disparities (NIMHD)
• Information provided by (Responsible Party): Klein Buendel, Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Sickle Cell Disease
• Intervention: Other: Pinpoint App
• Enrollment: 13

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Pinpoint App Usability Testing
Arm/Group Description	Participants used the Pinpoint tablet app for one hour.
Period Title: Overall Study
Started	13
Completed	12
Not Completed	1

Baseline Characteristics

Arm/Group Title		Pinpoint App Usability Testing
Arm/Group Description		Participants used the Pinpoint tablet app for one hour.
Overall Number of Baseline Participants		12
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	12 participants
		14.58 (1.00)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants
	Female	5 41.7%
	Male	7 58.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	12 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	11 91.7%
	White	0 0.0%
	More than one race	1 8.3%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	12 participants
		12

Outcome Measures

1. Primary Outcome

Title	System Usability Questionnaire
Description	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.
Time Frame	After 1-hour usability session

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pinpoint App
Arm/Group Description:	Tablet application. Pinpoint App: Tablet app with pain assessment and communication education, and pain assessment tool.
Overall Number of Participants Analyzed	12
Mean (Standard Deviation); Unit of Measure: units on a scale
	86.67 (11.56)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Pinpoint App
Arm/Group Description	Tablet application. Pinpoint App: Tablet app with pain assessment and communication education, and pain assessment tool.
All-Cause Mortality
	Pinpoint App
	Affected / at Risk (%)
Total	0/12 (0.00%)
Serious Adverse Events
	Pinpoint App
	Affected / at Risk (%)
Total	0/12 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Pinpoint App
	Affected / at Risk (%)
Total	0/12 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Valerie Myers, PhD
• Organization: Klein Buendel
• Phone: 3035654343
• EMail: vmyers@kleinbuendel.com

Publications:

Brawley OW, Cornelius LJ, Edwards LR, Gamble VN, Green BL, Inturrisi C, James AH, Laraque D, Mendez M, Montoya CJ, Pollock BH, Robinson L, Scholnik AP, Schori M. National Institutes of Health Consensus Development Conference statement: hydroxyurea treatment for sickle cell disease. Ann Intern Med. 2008 Jun 17;148(12):932-8. doi: 10.7326/0003-4819-148-12-200806170-00220. Epub 2008 May 5. No abstract available.

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.

Bhagat VM, Baviskar SR, Mudey AB, Goyal RC. Poor health related quality of life among patients of sickle cell disease. Indian J Palliat Care. 2014 May;20(2):107-11. doi: 10.4103/0973-1075.132622.

Schnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; a general overview. Neth J Med. 2004 Nov;62(10):364-74.

Stinson J, Naser B. Pain management in children with sickle cell disease. Paediatr Drugs. 2003;5(4):229-41. doi: 10.2165/00128072-200305040-00003.

Ameringer S, Elswick RK Jr, Smith W. Fatigue in adolescents and young adults with sickle cell disease: biological and behavioral correlates and health-related quality of life. J Pediatr Oncol Nurs. 2014 Jan-Feb;31(1):6-17. doi: 10.1177/1043454213514632. Epub 2013 Dec 30.

Dampier C, Ely B, Brodecki D, O'Neal P. Characteristics of pain managed at home in children and adolescents with sickle cell disease by using diary self-reports. J Pain. 2002 Dec;3(6):461-70. doi: 10.1054/jpai.2002.128064.

Schatz J, Schlenz AM, McClellan CB, Puffer ES, Hardy S, Pfeiffer M, Roberts CW. Changes in coping, pain, and activity after cognitive-behavioral training: a randomized clinical trial for pediatric sickle cell disease using smartphones. Clin J Pain. 2015 Jun;31(6):536-47. doi: 10.1097/AJP.0000000000000183.

Dampier C, Lieff S, LeBeau P, Rhee S, McMurray M, Rogers Z, Smith-Whitley K, Wang W; Comprehensive Sickle Cell Centers (CSCC) Clinical Trial Consortium (CTC). Health-related quality of life in children with sickle cell disease: a report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Pediatr Blood Cancer. 2010 Sep;55(3):485-94. doi: 10.1002/pbc.22497.

Crandall M, Savedra M. Multidimensional assessment using the adolescent pediatric pain tool: a case report. J Spec Pediatr Nurs. 2005 Jul-Sep;10(3):115-23. doi: 10.1111/j.1744-6155.2005.00023.x.

Franck LS, Treadwell M, Jacob E, Vichinsky E. Assessment of sickle cell pain in children and young adults using the adolescent pediatric pain tool. J Pain Symptom Manage. 2002 Feb;23(2):114-20. doi: 10.1016/s0885-3924(01)00407-9.

Lopez G, Liles DK, Knupp CL. Edmonton Symptom Assessment System for outpatient symptom monitoring of sickle cell disease. South Med J. 2014 Dec;107(12):768-72. doi: 10.14423/SMJ.0000000000000209.

Panepinto JA, O'Mahar KM, DeBaun MR, Loberiza FR, Scott JP. Health-related quality of life in children with sickle cell disease: child and parent perception. Br J Haematol. 2005 Aug;130(3):437-44. doi: 10.1111/j.1365-2141.2005.05622.x.

• 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 Submitted: September 20, 2017
• First Posted: September 25, 2017
• Results First Submitted: July 25, 2018
• Results First Posted: February 6, 2019
• Last Update Posted: February 6, 2019