Diabetes Strengths Study - Pilot of Provider-delivered Strengths-based Intervention (DSS)
2020年2月11日 更新者：Marisa Hilliard、Baylor College of Medicine
Promoting Resilience in Youth With Type 1 Diabetes: Pilot of Strengths-Based Family Intervention to Improve Diabetes Outcomes (Diabetes Strengths Study)
The purpose of this study is to determine whether a newly developed intervention is feasible and acceptable to adolescents with type 1 diabetes and their families and diabetes care providers, and to evaluate trends in whether the intervention impacts important diabetes outcomes.
The intervention involves diabetes care providers discussing and reinforcing individuals' and families' diabetes management strengths during routine, outpatient diabetes care appointments.
研究概览
详细说明
The purpose of this study is to pilot test a newly developed strengths-based clinical intervention delivered by diabetes care providers in the context of routine ambulatory diabetes care, designed to promote resilience and support diabetes management among adolescents with type 1 diabetes and their families. The emphasis of the intervention is shifting the tone of clinical encounters for diabetes care to emphasize and reinforce youths' and families' current diabetes strengths and positive diabetes management behaviors. Youth with type 1 diabetes are seen routinely in clinic every 3-4 months, and this intervention will occur at two consecutive clinic visits. The intervention consists of (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.
Outcome assessments are conducted at baseline (prior to the start of the intervention) and immediately following the conclusion of the intervention (approximately 6-8 months later). The primary outcome is feasibility and acceptability, measured by qualitative feedback from participants and providers, as well as quantification of recruitment and enrollment, provider adherence to intervention protocol, and time to completion. Secondary (exploratory) outcomes include diabetes regimen adherence, glycemic control, family conflict, diabetes burden, diabetes strengths, and satisfaction with the diabetes care provider relationship. Strengths and adherence assessments are also completed prior to the second clinic visit to generate the diabetes strengths profile.
研究类型
介入性
注册 (实际的)
172
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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Texas
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Houston、Texas、美国、77030
- Baylor College of Medicine
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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
12年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- At least one parent of each adolescent, self-identified as the primary caregiver most involved in diabetes care, will also be enrolled with each adolescent participant. When present, secondary caregivers involved in diabetes management will be invited (not required) to participate.
- Youth type 1 diabetes diagnosis for at least 12 months, to allow ample opportunity for adjustment to diabetes management
- Youth and parent fluency in written and spoken English because assessment measures are not available in other languages.
Exclusion Criteria:
(1) Presence of a serious mental illness or developmental disability in youth or parent that would impede participation would exclude eligibility.
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：其他
- 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：Intervention
There is no control/comparator group for this pilot study - all participants receive the intervention
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The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique "diabetes strengths profile" generated from the strengths and adherence assessments.
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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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Feasibility of Study Design
大体时间：Immediately following Enrollment (Baseline)
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Measured by percent of recruited families that enrolled in study
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Immediately following Enrollment (Baseline)
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Feasibility of Study Design
大体时间：6-8 months after enrollment (follow-up timepoint)
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Measured by percent of enrolled participants who receive full dose
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6-8 months after enrollment (follow-up timepoint)
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Feasibility of Study Design
大体时间：6-8 months after enrollment (follow-up timepoint)
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Measured by time to complete intervention in months since enrollment in study.
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6-8 months after enrollment (follow-up timepoint)
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Feasibility of Study Design
大体时间：6-8 months after intervention begins (immediately following second study visit)
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Measured by percent of participants who provided complete data from all questionnaires.
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6-8 months after intervention begins (immediately following second study visit)
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Acceptability: Number of Participants That Felt the Intervention Was Well-Received
大体时间：6-8 months after enrollment (follow-up timepoint)
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The number of participants that felt the intervention was well-received was collected for Adolescents, Parents, and Providers.
To determine if the intervention was well-received, verbal responses from qualitative interviews with were coded for types of participant feedback by the study team.
We coded these data qualitatively and classified them as Positive, Negative, or Neutral.
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6-8 months after enrollment (follow-up timepoint)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diabetes Strengths
大体时间：3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
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Adolescent will self-report on the frequency of 12 resilience-promoting behaviors via the Diabetes Strengths and Resilience, a self-report assessment of positive behaviors related to diabetes resilience for youth with type 1 diabetes, such as perceived competence to manage the demanding diabetes regimen, to adapt to the unpredictability of diabetes, and to seek help and support with diabetes challenges.
The scale ranges from 0-48, with a higher score representing a better outcome.
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3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
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Diabetes Self-Management Profile - Parent-report
大体时间：3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
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Parents will rate adolescents' adherence to the diabetes regimen using the 24-item Diabetes Self-Management Profile Self-Report.
The version appropriate to their child's current diabetes regimen (conventional insulin regimen, 24 items; flexible insulin regimen, 24 items) was administered.
The scale ranges from 0-86, with a higher score representing a better outcome.
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3-4 months after enrollment (mid-intervention timepoint), and 6-8 months after enrollment (follow-up timepoint)
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Diabetes Self-Management Profile - Adolescent-report
大体时间：6-8 months after enrollment (follow-up timepoint)
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Adolescents will complete the youth-report version of the Diabetes Self-Management Profile Self-Report, a self-reported measure of adherence to diabetes regimen, at baseline and follow-up to assess their perceptions of adherence.
The version appropriate to the adolescents' current diabetes regimen (conventional insulin regimen, 24 items; or intensive insulin regimen, 24 items) will be administered.
The scale ranges from 0-86, with a higher score representing a better outcome.
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6-8 months after enrollment (follow-up timepoint)
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Diabetes Regimen Adherence (Blood Glucose Monitoring Frequency)
大体时间：6-8 months after enrollment (follow-up timepoint)
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Objective measurement of adherence will occur through blood glucose monitoring frequency (a well-accepted surrogate of overall adherence), obtained via blood glucose meter downloads.
The average daily frequency will be calculated over the 14 days prior to the assessment at the Baseline and second study visits.
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6-8 months after enrollment (follow-up timepoint)
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Glycemic Control
大体时间：6-8 months after enrollment (follow-up timepoint)
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Diabetes is typically diagnosed with an HbA1c of 6.5% or higher.
At the time of this study, the American Diabetes Association generally recommended an HbA1c target of <7.5% for individuals younger than 18 years (the specific target varies depending on the individual).
The DCA 2000 HbA1c Analyzer (Siemens-Bayer) was used for point of care HbA1c analysis, it has an analytical measurement range for HbA1c of 2.5% to 14.0%.
HbA1c values are collected via fingerstick and blood assay at routine diabetes care visits and values will be extracted from the medical record at each clinic visit during the study period.
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6-8 months after enrollment (follow-up timepoint)
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Problem Areas in Diabetes - Teen
大体时间：6-8 months after enrollment (follow-up timepoint)
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Burden will be assessed via the Problem Areas in Diabetes - Teen.
The scale has 26 items and demonstrates good psychometric properties.
The scale ranges from 26-156, with higher scores representing worse outcomes.
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6-8 months after enrollment (follow-up timepoint)
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Diabetes Burden - Problem Areas in Diabetes - Parent-report
大体时间：6-8 months after enrollment (follow-up timepoint)
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Burden will be assessed via the Problem Areas in Diabetes measures for parents.
The scale has 26 items and demonstrates good psychometric properties.
The scale ranges from 26-156, with a higher score representing a worse outcome.
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6-8 months after enrollment (follow-up timepoint)
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Diabetes-related Family Conflict (Parent-report)
大体时间：6-8 months after enrollment (follow-up timepoint)
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Parents will complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity.
The scale ranges from 19-57, with higher scores representing a worse outcome.
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6-8 months after enrollment (follow-up timepoint)
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Diabetes-related Family Conflict (Adolescent Report)
大体时间：6-8 months after enrollment (follow-up timepoint)
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Adolescents will also complete the Diabetes Family Conflict Scale Revised, a 19 item scale with good reliability and validity.
The scale ranges from 19-57, with higher scores representing a worse outcome.
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6-8 months after enrollment (follow-up timepoint)
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Healthcare Satisfaction - PedsQL Healthcare Satisfaction Parent-report
大体时间：6-8 months after enrollment (follow-up timepoint)
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To assess healthcare satisfaction, parents will complete three subscales of the PedsQL Inventory Healthcare Satisfaction Generic Module, assessing their satisfaction with communication, inclusion of family, and how well the patient's emotional needs are addressed during the clinical encounter (13 items).
The scale ranges from 0-100, with a higher score representing a better outcome.
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6-8 months after enrollment (follow-up timepoint)
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Adolescent-provider Relationship - Adolescent-report
大体时间：6-8 months after enrollment (follow-up timepoint)
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Adolescents will rate their overall satisfaction with the patient-provider relationship on a 1-10 scale single item developed for this study, as there is no validated youth-report measure of satisfaction with care.
The scale ranges from 1-10, with higher scores representing a better outcome.
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6-8 months after enrollment (follow-up timepoint)
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Provider-family Relationship, Provider-report
大体时间：6-8 months after enrollment (follow-up timepoint)
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Providers will rate their overall satisfaction with the provider-family relationship on a scale developed for this study.
The Provider-Family Relationship scale measures the provider's perspective on the quality of their relationship with the teen and family.
4 healthcare providers completed this scale for 48 families.
The scale range of the minimum to maximum possible score is 1-10.
A higher score represents a better outcome.
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6-8 months after enrollment (follow-up timepoint)
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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。
调查人员
- 首席研究员：Marisa E Hilliard, PhD、Baylor College of Medicine
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。
有用的网址
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
2014年7月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2015年7月27日
首先提交符合 QC 标准的
2015年7月27日
首次发布 (估计)
2015年7月29日
研究记录更新
最后更新发布 (实际的)
2020年2月24日
上次提交的符合 QC 标准的更新
2020年2月11日
最后验证
2020年2月1日
更多信息
与本研究相关的术语
其他研究编号
- H-34857
- 1K12DK097696 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Participants receive informed consent form and a profile of results from two surveys completed during intervention, other participant data not returned to participant
IPD 共享时间框架
Receive informed consent form upon signing, and receive profile of results from 2 intervention surveys at the intervention sessions
IPD 共享访问标准
All participants receive informed consent form and survey result profile
IPD 共享支持信息类型
- 国际碳纤维联合会
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.
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