Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-Age Families
糖尿病困扰的补救措施 (R2D2):针对学龄家庭的可扩展筛查治疗计划
基本信息
- 批准号:10264072
- 负责人:
- 金额:$ 64.8万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-09-05 至 2025-08-31
- 项目状态:未结题
- 来源:
- 关键词:12 year old8 year oldAddressAdoptedAmericanAngerBehavior TherapyBehavioralBehavioral ModelCaregiversCaringChildChildhood diabetesClinicClinic VisitsClinicalClinical TrialsCognitiveCognitive TherapyComplexComplications of Diabetes MellitusConsumptionDataDepressed moodDiabetes MellitusDistressEducational CurriculumEmotional StressFamilyFoundationsFrightFutureGlucoseGlycosylated HemoglobinGrief reactionGuidelinesHybridsHypoglycemiaInsulin-Dependent Diabetes MellitusInterventionKnowledgeLongitudinal StudiesMathematicsMeasuresMemoryMental DepressionModalityModelingModernizationOutcomeParentsPathway interactionsPersonsPhasePublic HealthReportingResearchResearch DesignResearch PersonnelResourcesSchool-Age PopulationSchoolsScientistSeriesSystemTechniquesTestingTherapeuticTimeUnited StatesYouthacceptability and feasibilitybaseclinical careclinically relevantcomparative effectivenesscopingcost effectivecrowdsourcingdata registrydesigndiabetes distressdiabetes self-managementevidence baseexperiencefeasibility testingglucose monitorglycemic controlhemoglobin Phigh riskimplementation scienceimprovedinnovationinterestmHealthmindfulnessmultidisciplinarynovelpatient subsetsprogramsrecruitresilienceresponserestraintroutine screeningscreeningscreening programskillsstandard of caretelehealththerapy developmenttime usetrenduptake
项目摘要
PROJECT SUMMARY
While ~25% of school-age children with type 1 diabetes (T1D) achieve an HbA1c of <7.5%, the majority of
school-age children do not and are at a higher risk for T1D-related complications. Achieving optimal T1D self-
care is currently the only direct pathway to better HbA1c and even with the addition of modern therapeutic
modalities (e.g., hybrid closed loop), T1D self-care is a complex, time-consuming, and relentless task. School-
age children need support from their parents to effectively manage T1D and therefore both parents and youth
with T1D are vulnerable to Diabetes Distress (DD). Presently, the American Diabetes Association (ADA)
Standards of Care recommend assessment of DD during routine diabetes clinic visits in youth and their
caregivers starting when youth are ~8-years-old. Unfortunately, while DD screening may be an ADA Care
Standard, there are no practical and evidence-based screen-to-treat programs for clinics to adopt to meet this
Standard of Care. We submit this new R01 in response to RFA-DK-19-021, Treating Diabetes Distress to
Improve Glycemic Outcomes in Type 1 Diabetes. Our objective is to test the feasibility and acceptability of a
novel, practical, and scalable screen-to-treat program for DD in school-age children and their parents (called
Remedy to Diabetes Distress [R2D2]) and to test the initial efficacy of R2D2 to reduce DD to improve children's
glycemic control. Our specific aims are: 1) Define and iteratively refine our new screen-to-treat program (R2D2)
for DD in school-age families in order to maximize feasibility and acceptability to stakeholders, and 2) Establish
initial efficacy of R2D2 to reduce parent and child DD to improve child glycemic control. To enhance scientific
rigor, we will use the ORBIT Model for Behavioral Intervention Development to guide our study design. The
ORBIT Model proposes a phased approach using a series of small, cost-effective studies to determine clinically-
meaningful targets and to test a treatment's acceptability and initial efficacy before embarking on a large clinical
trial. For ORBIT Phase 1a: Define, we will conduct a brief longitudinal study to establish cut-points for clinically
relevant DD in parents and school-age children, engage clinic Quality Improvement teams to develop a practical
clinic-based screening approach, and use crowdsourcing techniques to obtain family input on a new mHealth
treatment. For ORBIT Phase 1b: Refine, we will test implementation of our R2D2 screening program across
multiple clinics and we will conduct a small trial to identify an initially efficacious and practical mHealth treatment
delivery approach for R2D2. Finally, for ORBIT Phase 2a, we will continue to screen for DD in clinic and recruit
families who report clinically relevant DD into a Proof of Concept Pilot to examine whether ameliorating parent
and/or child DD leads to improved child glycemic control. We believe our study optimally responds to the FOA
because our: 1-research team is multidisciplinary and includes a true partnership between a behavioral scientist
and a diabetologist, 2-R2D2 screen-to-treat program reflects a practical approach that could realistically occur
in clinic, 3-use of Implementation Science will further enhance future sustainability and dissemination of R2D2.
项目摘要
虽然约25%的1型糖尿病(T1 D)学龄儿童的HbA 1c <7.5%,但大多数儿童的HbA 1c <7.5%。
学龄儿童没有,并且有更高的T1 D相关并发症的风险。实现最佳T1 D自我-
护理是目前改善HbA 1c的唯一直接途径,即使添加了现代治疗药物,
模态(例如,混合闭环),T1 D自我护理是一项复杂、耗时且无情的任务。学校-
年龄的儿童需要父母的支持来有效地管理T1 D,因此父母和青少年都需要
T1 D患者易受糖尿病困扰(DD)的影响。美国糖尿病协会(ADA)
护理标准建议在青少年常规糖尿病门诊访视期间评估DD,
照顾者从青少年约8岁开始。不幸的是,虽然DD筛查可能是ADA护理
标准,没有实际的和基于证据的筛查治疗计划,诊所采用,以满足这一点
护理标准。我们提交这一新的R 01以回应RFA-DK-19-021,治疗糖尿病困扰,
1型糖尿病的治疗方法我们的目标是测试一个
一种新颖、实用、可扩展的学龄儿童及其父母DD筛查治疗计划(称为
糖尿病苦恼的补救措施[R2D2]),并测试R2D2减少DD以改善儿童
血糖控制我们的具体目标是:1)定义并迭代完善我们新的筛查到治疗计划(R2D2)
为学龄家庭的DD,以最大限度地提高可行性和利益相关者的可接受性,以及2)建立
R2 D2降低父母和孩子DD以改善儿童血糖控制的初步功效。加强科学
严格来说,我们将使用ORBIT行为干预发展模型来指导我们的研究设计。的
ORBIT模型提出了一种分阶段的方法,使用一系列小型,具有成本效益的研究来确定临床-
有意义的目标,并测试治疗的可接受性和初步疗效,然后再进行大规模的临床试验。
审判对于ORBIT 1a期:定义,我们将进行一项简短的纵向研究,以确定临床
在家长和学龄儿童的相关DD,聘请诊所质量改进小组,以制定一个切实可行的
以诊所为基础的筛查方法,并使用众包技术,以获得家庭对新的移动健康的投入
治疗对于ORBIT Phase 1b:Refine,我们将测试R2D2筛查计划的实施情况,
我们将进行一项小型试验,以确定一种最初有效和实用的移动医疗治疗方法。
R2D2的交付方式。最后,对于ORBIT 2a期,我们将继续在临床和招募中筛查DD
向概念验证试点报告临床相关DD的家庭,以检查是否改善父母
和/或儿童DD导致改善的儿童血糖控制。我们相信我们的研究最佳响应FOA
因为我们的研究团队是多学科的,包括行为科学家和
和糖尿病学家,2-R2D2筛查到治疗计划反映了一种实际可行的方法,
在临床中,3-使用实施科学将进一步加强R2D2未来可持续性和传播。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Susana R Patton其他文献
Digital Gaming and Exercise Among Youth With Type 1 Diabetes: Cross-Sectional Analysis of Data From the Type 1 Diabetes Exercise Initiative Pediatric Study
1 型糖尿病青少年的数字游戏和锻炼:1 型糖尿病锻炼计划儿科研究数据的横断面分析
- DOI:
- 发表时间:
2024 - 期刊:
- 影响因子:3.7
- 作者:
Susana R Patton;Robin L. Gal;Simon Bergford;P. Calhoun;M. Clements;J. Sherr;Michael C Riddell - 通讯作者:
Michael C Riddell
Susana R Patton的其他文献
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{{ truncateString('Susana R Patton', 18)}}的其他基金
Coin2Dose: Behavioral economics to promote insulin BOLUS activity and improve HbA1c in teens
Coin2Dose:促进胰岛素 BOLUS 活性并改善青少年 HbA1c 的行为经济学
- 批准号:
10229287 - 财政年份:2021
- 资助金额:
$ 64.8万 - 项目类别:
Coin2Dose: Behavioral economics to promote insulin BOLUS activity and improve HbA1c in teens
Coin2Dose:促进胰岛素 BOLUS 活性并改善青少年 HbA1c 的行为经济学
- 批准号:
10597657 - 财政年份:2021
- 资助金额:
$ 64.8万 - 项目类别:
Coin2Dose: Behavioral economics to promote insulin BOLUS activity and improve HbA1c in teens
Coin2Dose:促进胰岛素 BOLUS 活性并改善青少年 HbA1c 的行为经济学
- 批准号:
10380892 - 财政年份:2021
- 资助金额:
$ 64.8万 - 项目类别:
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-Age Families
糖尿病困扰的补救措施 (R2D2):针对学龄家庭的可扩展筛查治疗计划
- 批准号:
10667527 - 财政年份:2020
- 资助金额:
$ 64.8万 - 项目类别:
Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-Age Families
糖尿病困扰的补救措施 (R2D2):针对学龄家庭的可扩展筛查治疗计划
- 批准号:
10471397 - 财政年份:2020
- 资助金额:
$ 64.8万 - 项目类别:
Home Video-Based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
基于家庭视频的远程医疗可减少幼儿家长对低血糖的恐惧
- 批准号:
10081476 - 财政年份:2019
- 资助金额:
$ 64.8万 - 项目类别:
Home Video-Based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
基于家庭视频的远程医疗可减少幼儿家长对低血糖的恐惧
- 批准号:
9901522 - 财政年份:2019
- 资助金额:
$ 64.8万 - 项目类别:
Home Video-Based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children
基于家庭视频的远程医疗可减少幼儿家长对低血糖的恐惧
- 批准号:
10381509 - 财政年份:2019
- 资助金额:
$ 64.8万 - 项目类别:
Longitudinal test of adherence & control in kids new to T1 diabetes & 5-9 yrs old
纵向依从性测试
- 批准号:
9301535 - 财政年份:2014
- 资助金额:
$ 64.8万 - 项目类别:
Modifiable Behavior & Dietary Predictors of Overweight in Children with ASD
可修改的行为
- 批准号:
8637572 - 财政年份:2014
- 资助金额:
$ 64.8万 - 项目类别:
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