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临床试验/NCT05510531
NCT05510531已完成不适用

A Study to Evaluate the Feasibility and Acceptability of a Diabetes Survival Skills + (DSS+) Training Intervention for Incarcerated Persons Transitioning to the Community (TTC)

University of Connecticut2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2017年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Change in outcome expectancy

研究概览

简要总结

The purpose was to examine the feasibility and acceptability of a Diabetes Survival Skills intervention training with and without a support group for incarcerated persons transitioning to the community. Feasibility will include limited efficacy testing to examine the effect of the DSS+ intervention on diabetes knowledge, self-efficacy, outcome expectancies, and diabetes-related distress.

详细描述

Prison programs often lack efficacious diabetes self-management education (DSME)or skill-based programs to prepare citizens with diabetes when transitioning from a highly dependent secure environment to independent community living. There have been efforts to examine the effect of engaging incarcerated persons in blood glucose monitoring on glycemic control,11 but for the most part incarcerated persons or those recently released have not been included in decades of research involving community dwelling and ethnically diverse persons in numerous effective tailored and culturally relevant group/individual models of DSME for improving diabetes knowledge,12-14 self-care behavior (SCB),11,12,14 and stimulating participation in proactive risk reduction;16,17because incarcerated adults are considered a vulnerable population. These adults often have some cognitive dysfunction18 with lower than average prose, as well as decreased literacy across age, sex, and educational attainment, than those living in community households.19 With release into the community, these individuals undergo significant stress due to competing demands such as finding housing, and employment that can adversely affect DSM. It is unknown whether the evidence based DSME strategies used in the general community such as with discharge from the hospital to home are feasible, acceptable and effective for best supporting the transition of incarcerated persons in their continued DSM into the community. For example, one study reported prisoners, at seven days' post prison release, had higher rates of hospitalization for short-term diabetes complications and lower extremity amputations compared to matched controls.3 Interviews with recently released prisoners revealed significant stress post-release related to not knowing how and when to take insulin.20 In another study, respondents reported lack of knowledge regarding what foods to eat, how to control their blood sugar, take medications, or access health care. 21 At a minimum, incarcerated persons transitioning to the community have a critical need for DSS. Therefore, the purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of implementing a 6 week DSS Training Intervention in the correctional setting 6-9months before incarcerated persons transition to the community.

Specific aims:

  1. The primary aim is to evaluate feasibility of the experimental protocol: H1) Recruitment: 48 eligible persons will consent to participate in the study within 2 months. H2) Attendance/Attrition: 90% of enrolled participants will attend and complete the 6-session DSS Training. H3) Engagement: 75% of enrolled participants' will document responses to work-book questions, record blood glucose and if applicable associated diet or activity information. H4) Intervention implementation: The intervention will be delivered according to the DSS timeline (Figure1) and session outline. H5) Skill proficiency: Participants will return demonstrate how to use the blood glucose meter, insulin pen (as indicated), and blood glucose log, and other skills specific to DSS session 1-6.

The secondary aim is to elicit information about the participant's acceptability of the DSS intervention including perspective in participating in the intervention using focus groups.

  1. The tertiary aim is to explore the preliminary efficacy and short term impact of the DSS Intervention on diabetes knowledge, outcome expectancies, emotional distress, and self-efficacy (Information-Motivation-Behavior Model [IMB]22,23 outcomes) at baseline, 6 weeks, and 12 weeks.

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
Male
接受健康志愿者

入选标准

  • Eligible individuals:
  • have Type 1 or 2 diabetes
  • be male gender
  • age 18 and older
  • any race, or ethnicity
  • be able to speak, and understand Englis
  • within 6-9 months of being released from prison
  • have a Connecticut Department of Corrections (CDOC) security and medical classification allowing participation in group sessions
  • none. See inclusion

排除标准

  • none. See inclusion

结局指标

主要结局

Change in outcome expectancy

时间窗: Measured at Baseline and 6 and 12 weeks from baseline.

Outcome Expectancy Questionaire(OEQ) measures a "person's perceptions of the consequences of performing diabetes self-care behavior

Change in diabetes knowledge

时间窗: Measured at Baseline and 6 and 12 weeks from baseline

measured by Spoken knowledge for Low Literacy in Diabetes (SKILLD) , a 10-item scale that measures diabetes knowledge e.g. medication taking, blood glucose monitoring

Change in self-confidence for managing diabetes

时间窗: Measured at Baseline and 6 and 12 weeks from baseline

Self confidence in Diabetes Index(SCODI) Confidence Subscale 38 measures the degree of confidence the person has about his or her ability to perform specific self-care task and to persist in forming an action despite barriers

Change in diabetes-related distress

时间窗: Measured at Baseline and 6 and 12 weeks from baseline.

Problem Areas in Diabetes Scale (PAID) measures diabetes-related distress.

次要结局

  • Participants perspective of the intervention(Focus group interview performed between 8-12 weeks after the session/intervention is delivered.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louise Reagan

Assistant Professor

University of Connecticut

研究点 (2)

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