Gaming Technology to Engage Adolescent Sickle Cell Patients in Pain Management

NCT03291613 | Completed Results

• 2 other identifiers: 1R43MD010746-010308
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet assessments to identify type, intensity, frequency, and phase of pain among SCD adolescents is 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 their self-care. Pinpoint is an interactive gaming tablet app that will be developed with the significant input of clinical experts to assist SCD teens with better identification and self-report of their pain.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Adolescence; Pain Assessment; Tablet Application; Pain; mHealth

Outcome Measures

Primary Outcomes (1)

• System Usability Questionnaire

  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.

  After 1-hour usability session

Study Arms (1)

Pinpoint App

EXPERIMENTAL

Tablet application.

Other: Pinpoint App

Interventions

Pinpoint App OTHER

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

Pinpoint App

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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
• Be a healthcare provider to teens with sickle cell disease
• Be 18 years of age or older
• Able to read and speak English
• Able to consent to participate
• Not a healthcare provider to teens with sickle cell disease
• Not 18 years of age or older
• Unable to read and speak English
• Unable to consent to participate

Sponsors & Collaborators

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

Study Sites (2)

Klein Buendel, Inc.

Golden, Colorado, 80401, United States

Location

Hilton Publishing Company

Munster, Indiana, 463213963, United States

Location

Related Publications (14)

• 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.

  PMID: 18458271 BACKGROUND

• Cope A, Darbyshire PJ. Sickle cell disease, update on management. Paediatrics and Child Health. 2013;23(11):480-485.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25125865 BACKGROUND

• 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.

  PMID: 15683091 BACKGROUND

• 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.

  PMID: 12662119 BACKGROUND

• 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.

  PMID: 24378816 BACKGROUND

• 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.

  PMID: 14622732 BACKGROUND

• 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.

  PMID: 25503599 BACKGROUND

• 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.

  PMID: 20658620 BACKGROUND

• 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.

  PMID: 16083431 BACKGROUND

• 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.

  PMID: 11844631 BACKGROUND

• 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.

  PMID: 25502156 BACKGROUND

• 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.

  PMID: 16042695 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Valerie Myers, PhD
• Organization: Klein Buendel

vmyers@kleinbuendel.com

3035654343

Study Officials

• Valerie Myers, PhD

  Klein Buendel, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: January 15, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: February 6, 2019
• Results First Posted: February 6, 2019

Record last verified: 2019-01

Locations

US (2)