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

September 18, 2023 updated by: Louise Reagan, University of Connecticut

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Storrs, Connecticut, United States, 06269-0001
        • University of Connecticut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Diabetes Survival Skills (DSS)Training
Participants in the treatment group received a 6-session 1-hour weekly literacy tailored DSS education intervention.
Behavioral: Diabetes Survival Skills Training
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.
No Intervention: Control No intervention
Participants in the Control facility received the intervention upon completion of week twelve measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diabetes knowledge
Time Frame: 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
Measured at Baseline and 6 and 12 weeks from baseline
Change in diabetes-related distress
Time Frame: Measured at Baseline and 6 and 12 weeks from baseline.
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
Time Frame: 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
Measured at Baseline and 6 and 12 weeks from baseline
Change in outcome expectancy
Time Frame: 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
Measured at Baseline and 6 and 12 weeks from baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants perspective of the intervention
Time Frame: Focus group interview performed between 8-12 weeks after the session/intervention is delivered.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Connecticut

Collaborators

American Nurses Foundation

Investigators

  • Principal Investigator: Louise Reagan, PhD, UCONN School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 18, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17-066

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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