Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change from baseline in psychological insulin resistance at 2 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: I-START (Behavioral)
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.
干预措施: Standard Insulin Administration Education (Behavioral)
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.
干预措施: Standard Insulin Administration Education (Behavioral)
结局指标
主要结局
Change from baseline in psychological insulin resistance at 2 weeks
时间窗: 2 weeks
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.
Change from baseline in psychological insulin resistance at 3 months
时间窗: 3 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.
Change from baseline in psychological insulin resistance at 6 months
时间窗: 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.
次要结局
- Change from baseline in diabetes distress at 3 months(3 months)
- Change from baseline in diabetes distress at 6 months(6 months)
- Patient Satisfaction(6 months)
- Provider Satisfaction(6 months)
- Change from baseline in glycemic control at 3 months(3 months)
- Change from baseline in glycemic control at 6 months(6 months)
- Change from baseline in medication adherence at 3 months(3 months)
- Change from baseline in medication adherence at 6 months(6 months)
- Change from baseline in diabetes empowerment at 3 months(3 months)
- Change from baseline in diabetes empowerment at 6 months(6 months)
研究者
Linda Siminerio
Professor
University of Pittsburgh