Gaming Technology to Engage Adolescent Sickle Cell Patients in Pain Management
2019年1月14日 更新者:Klein Buendel, Inc.
PINPOINT: Gaming Technology to Engage Adolescent Sickle Cell Patients in Precision Pain Management
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.
研究概览
详细说明
Sickle cell disease (SCD) is the most common inherited blood disorder in the U.S. and disproportionately affects African Americans and Hispanics.
Approximately, 1,000 U.S. children are born with SCD annually.
SCD results from abnormal hemoglobin and causes red blood cells (RBCs) to become misshaped ("sickle-shaped").
Sickled cells can block the flow of blood in small arteries causing tissue and organ damage and other life-threatening comorbidities.
SCD complications can be serious and have a significant impact upon well-being and quality of life.
Pain is the hallmark symptom associated with SCD, and is the most common clinical problem seen in children and the number one cause of SCD-related hospital admissions.
If left untreated, these painful episodes can result in morbidity and mortality.
Accurate assessment of pain specifiers (type, frequency, and intensity of pain) can help with ameliorating pain quickly and effectively.
Despite children being accurate self-reporters of their pain, strategies which are effective and engaging to assist with pain identification are lacking.
Reducing barriers to collection and promoting the value of accurate SCD pain assessment is a need in pediatric medicine.
Pinpoint will be an innovative interactive assessment tool that engages patients while allowing physicians to collect important health data.
This project will test the feasibility of applying gamification principles to develop a tablet application ("app") for 13-17 year olds with SCD.
Specifically, this Phase I SBIR project will (1) develop a Pain Assessment Tool (PAT) to describe and categorize specific types of pain experienced by adolescents with SCD; and (2) create an app ("Pinpoint"), that will translate the PAT into gamified technology.
The goal of Pinpoint is to engage adolescent patients and improve pain specification by developing a game-based pain assessment tool delivered via a tablet app to engage adolescent SCD patients, improve their pain specification self-report, and improve pain management by clinicians.
The PAT will be developed using expert guidance from preeminent SCD clinicians.
User-centered Design theory will be applied in the development of the app and will be guided by iterative cognitive interviews and focus groups with members of the target population, SCD teens.
The project specific aims are to (1) develop the PAT using guidance from an Expert Advisory Board (EAB) of SCD clinicians; (2) conduct a series of cognitive interviews with adolescent SCD patients to guide and refine PAT development; (3) conduct iterative focus groups with adolescent SCD patients to guide and refine user interface design of the Pinpoint app; (4) program a functional Pinpoint prototype; and (5) conduct usability testing of the prototype with 13-17 year old SCD patients to assess functionality, navigation, and satisfaction.
This project is innovative and timely.
Pinpoint will be the first tablet app to identify and translate specific pain types for SCD into a gamified app using applied gamification principles.
研究类型
介入性
注册 (实际的)
13
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Colorado
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Golden、Colorado、美国、80401
- Klein Buendel, Inc.
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Indiana
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Munster、Indiana、美国、463213963
- Hilton Publishing Company
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
13年 及以上 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Phone Interview, Focus Group, and Usability 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
Phone Interview, Focus Group, and Usability 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
Healthcare Provider Interview Inclusion Criteria:
- 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
Healthcare Provider Interview Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Pinpoint App
Tablet application.
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Tablet app with pain assessment and communication education, and pain assessment tool.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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System Usability Questionnaire
大体时间:After 1-hour usability session
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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.
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After 1-hour usability session
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年1月15日
初级完成 (实际的)
2017年9月30日
研究完成 (实际的)
2017年9月30日
研究注册日期
首次提交
2017年9月20日
首先提交符合 QC 标准的
2017年9月20日
首次发布 (实际的)
2017年9月25日
研究记录更新
最后更新发布 (实际的)
2019年2月6日
上次提交的符合 QC 标准的更新
2019年1月14日
最后验证
2019年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Pinpoint App的临床试验
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Medical University of South CarolinaNational Cancer Institute (NCI)完全的
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Rutgers, The State University of New JerseyPfizer; American Cancer Society, Inc.完全的
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Research Center for Clinical Neuroimmunology and...Hoffmann-La Roche; Novartis Pharmaceuticals; University Hospital, Basel, Switzerland; University... 和其他合作者招聘中
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University of BernFreie Universität Berlin; Swiss Transfusion SRC完全的