Diabetes Survival Skills + (DSS+) Training Intervention for Incarcerated Persons Transitioning to the Community (TTC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 3. 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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Diabetes Survival Skills Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion: • none. See inclusion Exclusion Criteria: none. See inclusion -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed study will examine the feasibility, acceptability and preliminary efficacy measures of a quasi-experimental non-equivalent control group 6-week intervention study with repeated measures at baseline, 6 weeks, and 12 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Diabetes Survival Skills (DSS)Training<br>Participants in the treatment group received a 6-session 1-hour weekly literacy tailored DSS education intervention. | Behavioral: Diabetes Survival Skills Training<br>* During the course of the DSS sessions, participants receive blood glucose logs, glucose meters; lancets, testing strips and demonstration insulin pens with injecting pillow will only be used in class. In summary, the DSS is focused on increasing knowledge, motivation, and self-efficacy and decreasing diabetes related distress, IMB components relevant to incarcerated persons and proximal to behavior change, through engagement, return demonstrations, skill practice, and positive reinforcement.<br>|
| No Intervention: Control No intervention<br>Participants in the Control facility received the intervention upon completion of week twelve measurements. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diabetes knowledge | 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 | Measured at Baseline and 6 and 12 weeks from baseline | 
| Change in diabetes-related distress | Problem Areas in Diabetes Scale (PAID) measures diabetes-related distress. | Measured at Baseline and 6 and 12 weeks from baseline. | 
| Change in self-confidence for managing diabetes | 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 | Measured at Baseline and 6 and 12 weeks from baseline | 
| Change in outcome expectancy | Outcome Expectancy Questionaire(OEQ) measures a person's perceptions of the consequences of performing diabetes self-care behavior | Measured at Baseline and 6 and 12 weeks from baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants perspective of the intervention | Focus groups to perspective about the overall quality of the program? Or how well did the program prepare you for transitioning to the community? | Focus group interview performed between 8-12 weeks after the session/intervention is delivered. |