NCT05510531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

August 18, 2022

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Participants perspective of the intervention

    Focus group interview performed between 8-12 weeks after the session/intervention is delivered.

Study Arms (2)

Treatment Diabetes Survival Skills (DSS)Training

EXPERIMENTAL

Participants in the treatment group received a 6-session 1-hour weekly literacy tailored DSS education intervention.

Behavioral: Diabetes Survival Skills Training

Control No intervention

NO INTERVENTION

Participants in the Control facility received the intervention upon completion of week twelve measurements.

Interventions

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.

Treatment Diabetes Survival Skills (DSS)Training

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269-0001, United States

Location

Related Publications (2)

  • Todd S, Reagan L, Laguerre R. Health Literacy, Cognitive Impairment, and Diabetes Knowledge Among Incarcerated Persons Transitioning to the Community: Considerations for Intervention Development. J Forensic Nurs. 2023 Oct-Dec 01;19(4):262-270. doi: 10.1097/JFN.0000000000000396. Epub 2022 Apr 28.

  • Reagan L, Laguerre R, Todd S, Gallagher C. The Feasibility and Acceptability of a Diabetes Survival Skills Intervention for Persons Transitioning from Prison to the Community. J Racial Ethn Health Disparities. 2024 Apr;11(2):1014-1023. doi: 10.1007/s40615-023-01581-x. Epub 2023 May 8.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Louise Reagan, PhD

    UCONN School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 22, 2022

Study Start

March 8, 2017

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations