Insulin Start Therapy Application With Resources and Training (I-START)
2022年7月7日 更新者：Linda Siminerio、University of Pittsburgh
Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy
The purpose of the I-START study is to evaluate an educational phone application (app) designed to support patients with type 2 diabetes (T2DM) by reinforcing the necessary skills needed for insulin administration as part of diabetes self-management.
研究概览
详细说明
Despite advances in technology and delivery systems, patients with T2DM continue to be reluctant to begin and adhere to insulin therapy for a variety of reasons.
Introducing insulin therapy is particularly problematic during a hospitalization or a brief routine outpatient visit given time and resource constraints.
Teaching people to administer an insulin injection requires time and ongoing support.
Therefore, this study aims to evaluate an educational phone application designed to support patients with T2DM by reinforcing skills and self-management behaviors needed for insulin administration.
Patients with T2DM who are starting insulin or need updated instruction on insulin will be invited to participate in this study to examine the effect of the phone app on psychological barriers to insulin as well as patient and provider satisfaction with and usability of the phone app in both outpatient and hospital settings.
研究类型
介入性
注册 (实际的)
41
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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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh Medical Center
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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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 18 years of age
- Able to read and follow study instructions in English (translations will not be provided)
- T2DM requiring the use of prandial and/or long-acting insulin
- Ability to self-administer insulin therapy
- Willing to download the study app on their smartphone
- Able and willing to provide a signed consent
- Able and willing to follow all study procedures
Exclusion Criteria:
- Pregnant (self-reported)
- Participants from the same household participating concurrently
- Use of a smartphone with iOS version 10.0 or lower
- Use of a smartphone with Android OS 5.0 "Lollipop" or lower
- Currently using a continuous subcutaneous insulin infusion device
- Participants with major depression
- Currently or planning to participate in a similar study that would affect the results of this study
- Currently or planning to participate in a clinical study that involves taking a drug, supplement, or use of an investigational drug
- Continued hospitalization or transfer to an assisted living facility
- Any condition the PI or designee deems to pose a risk to the participant in the study (includes anything that may prevent full participation in the study)
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：治疗
- 分配：非随机化
- 介入模型：并行分配
- 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
Participants assigned to the intervention group will receive insulin administration education according to standard procedures plus have access to the I-START app.
Over the course of the study period, participants will be able to use I-START as much or as little as they prefer.
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Designed as a supplementary educational tool for patients on insulin therapy, I-START includes an injection plan to reinforce the knowledge and behaviors that users have been taught by their health care provider.
This is done through eight modules created for the benefit of new and experienced insulin users, and those using pens or vial/syringes.
The modules address a variety of topics pertinent to insulin therapy, including overcoming psychosocial barriers, injection techniques and best practices, managing hypo- and hyperglycemic events, monitoring blood glucose and troubleshooting and problem solving.
At the end of each module, users can self-evaluate their confidence in mastering the information presented.
This gives them the ability to move forward into the next module, repeat material already presented and/or save features of the modules that they would like to revisit at another time.
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
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有源比较器：Usual Care
Participants in the usual care group will receive insulin administration education according to standard procedures.
They will not have access to the I-START app.
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Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
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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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Change from baseline in psychological insulin resistance at 2 weeks
大体时间：2 weeks
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Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007).
The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia.
Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
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2 weeks
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Change from baseline in psychological insulin resistance at 3 months
大体时间：3 months
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Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007).
The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia.
Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
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3 months
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Change from baseline in psychological insulin resistance at 6 months
大体时间：6 months
|
Psychological insulin resistance will be assessed using the Barriers to Insulin Treatment Questionnaire (BIT), a short instrument that is easy to administer and may be used by both clinicians and researchers (Petrak et al, 2007).
The BIT Questionnaire includes 14 items, a total sum score, and the following five subscales: fear of injection and self-testing, expectations regarding positive insulin related outcomes, expected hardship from insulin treatment, stigmatization by insulin injection, and fear of hypoglycemia.
Each item is scored on a scale from 1 to 10, which are summed and averaged for total scores; the higher the score, the greater the level of concern.
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6 months
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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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Change from baseline in glycemic control at 3 months
大体时间：3 months
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Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control.
HbA1c will serve as the clinical study outcome and measure of glycemic control.
HbA1c values will be obtained from the electronic medical record (EMR) system.
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3 months
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Change from baseline in glycemic control at 6 months
大体时间：6 months
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Hemoglobin A1c (HbA1c) will serve as a clinical indicator of glycemic control.
HbA1c will serve as the clinical study outcome and measure of glycemic control.
HbA1c values will be obtained from the electronic medical record (EMR) system.
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6 months
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Change from baseline in medication adherence at 3 months
大体时间：3 months
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Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8).
The scales includes 8 items.
Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
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3 months
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Change from baseline in medication adherence at 6 months
大体时间：6 months
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Medication adherence will be assessed with the 8-item Morisky Medication Adherence Scale (MMAS-8).
Scores can range from 0 to 8; the higher the score, the more adherent the respondent is considered.
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6 months
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Change from baseline in diabetes empowerment at 3 months
大体时间：3 months
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Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003).
Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40.
Higher scores indicate greater empowerment.
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3 months
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Change from baseline in diabetes empowerment at 6 months
大体时间：6 months
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Empowerment will be measured using the 8-item Diabetes Empowerment Scale-Short Form (DES-SF), which measures an individual's perceived ability to manage psychosocial aspects of diabetes, assess dissatisfaction and readiness to change self-management plans and set and achieve diabetes goals (Anderson et al, 2000; Anderson et al, 2003).
Possible scores are 1 to 5 for each item, summed for a possible total score of 8 to 40.
Higher scores indicate greater empowerment.
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6 months
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Change from baseline in diabetes distress at 3 months
大体时间：3 months
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Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012).
Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
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3 months
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Change from baseline in diabetes distress at 6 months
大体时间：6 months
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Diabetes distress will be evaluated with the 17-item Diabetes Distress Scale (DDS17), which assesses four dimensions of distress - emotional, regimen, interpersonal and physician (Polonsky et al, 2005), and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM (Fisher et al, 2012).
Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress.
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6 months
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Patient Satisfaction
大体时间：6 months
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Patient satisfaction will be assessed using the validated Diabetes Medication System Rating Questionnaire-Short Form (DMSRQ-SF) (Peyrot et al, 2014).
Items are scored 0 to 100; higher scores equal greater levels of item/construct being measured.
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6 months
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Provider Satisfaction
大体时间：6 months
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Clinician experiences and perspectives on satisfaction of the app will be assessed through a study specific satisfaction survey
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6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient Usability
大体时间：6 months
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Patient usability will be tracked through the app's data analytics software platform.
Study staff will pull data from the data analytics software platform.
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6 months
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Provider usability
大体时间：6 months
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Clinician experiences and perspectives on the usability of the Briight app will be assessed a study specific usability survey.
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6 months
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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：Linda Siminerio, RN, PhD, CDE、Professor
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)
2019年11月25日
初级完成 (实际的)
2022年5月25日
研究完成 (实际的)
2022年5月25日
研究注册日期
首次提交
2019年6月21日
首先提交符合 QC 标准的
2019年6月25日
首次发布 (实际的)
2019年6月26日
研究记录更新
最后更新发布 (实际的)
2022年7月8日
上次提交的符合 QC 标准的更新
2022年7月7日
最后验证
2022年7月1日
更多信息
与本研究相关的术语
其他研究编号
- STUDY19040017
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
De-identified data set used for final analysis will be made available to other researchers who have obtained appropriate regulatory approval
IPD 共享时间框架
Data Set - After publication.
ICF - After completing data collection.
IPD 共享访问标准
Data set - other researchers will have to request access.
ICF will be added to clinicaltrials.gov
protocol
IPD 共享支持信息类型
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
I-START的临床试验
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University of North Carolina, Chapel HillInternational Agency for the Prevention of Blindness完全的
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University of New MexicoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)终止
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Baylor College of MedicineNational Institute of Mental Health (NIMH)完全的
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Assistance Publique - Hôpitaux de ParisCIA : CNGE IRMG Association; CNGE : Collège National des Généralistes Enseignants; RMG : Institut...未知