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

Sponsor
University of Connecticut (Other)
Overall Status
Completed
CT.gov ID
NCT05510531
Collaborator
American Nurses Foundation (Other)
92
1
2
22.1
4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diabetes Survival Skills Training
N/A

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.

  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.

Study Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Feasibility and Acceptability of a Diabetes Survival Skills + (DSS+) Training Intervention for Incarcerated Persons Transitioning to the Community (TTC)
Actual Study Start Date :
Mar 8, 2017
Actual Primary Completion Date :
Jan 10, 2019
Actual Study Completion Date :
Jan 10, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in diabetes knowledge [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

  2. Change in diabetes-related distress [Measured at Baseline and 6 and 12 weeks from baseline.]

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

  3. Change in self-confidence for managing diabetes [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

  4. Change in outcome expectancy [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

Secondary Outcome Measures

  1. Acceptability of the intervention by participants [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?

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Eligible individuals:1) have Type 1 or 2 diabetes, be male gender and age 18 and older, any race, or ethnicity 2) be able to speak, and understand English; 4) within 6-9 months of being released from prison; and 5) have a Connecticut Department of Corrections (CDOC) security and medical classification allowing participation in group sessions.

Exclusion Criteria: none. See inclusion

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Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Connecticut Storrs Connecticut United States 06269-0001

Sponsors and Collaborators

  • University of Connecticut
  • American Nurses Foundation

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Louise Reagan, Assistant Professor, University of Connecticut
ClinicalTrials.gov Identifier:
NCT05510531
Other Study ID Numbers:
  • H17-066
First Posted:
Aug 22, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022