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Diabetes App for Diabetes (LIVE JustICE Trial)

N/A
Recruiting
Led By Lousie Reagan, PhD
Research Sponsored by Louise Reagan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals will be eligible to participate if they are age 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

Summary

This trial will test the feasibility, acceptability and effects of a diabetes app. Outcomes will measure behavior change, knowledge, distress, self-care, social support and clinical results. Focus groups will be used to evaluate acceptability.

Who is the study for?
This trial is for adults aged 18 and older with Type 1 or Type 2 diabetes who have recently been released from one of five Connecticut prisons to supervised housing or parole. Participants must be able to speak and understand English.
What is being tested?
The study tests the Diabetes LIVE JustICE app against enhanced education, measuring its feasibility, acceptability, and impact on diabetes management over a period of 12 weeks with assessments at start, mid-point, and end.
What are the potential side effects?
Since this trial involves an educational application and enhanced education methods rather than medication or medical procedures, traditional physical side effects are not expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Demographics
Diabetes Knowledge
Diabetes-Related Emotional Distress
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Because eight avatars plus the educator avatar are allowed in the VE classroom at one time, we will cap enrollment for the feasibility study to allow for CHW and CDE training and the opportunity to work together during LIVE JustICE sessions. The DSMES will consist of six synchronous 1-hour education sessions and an hour support session for participants living in supervised community housing in the experimental group. We will run the six-week series sequentially a total of eleven times over 18 months. LIVE JustICE sessions will be held conveniently for participants, and days/times rotated if needed.
Group II: ControlActive Control1 Intervention
Participants randomized to the control group will receive enhanced pre-release diabetes education with registered or licensed practical nurse-delivered diabetes education about medications and insulin administration supplemented with the literacy tailored diabetes education packets used in the principal investigator's prior research.

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Who is running the clinical trial?

Louise ReaganLead Sponsor
American Diabetes AssociationOTHER
141 Previous Clinical Trials
99,500 Total Patients Enrolled
Lousie Reagan, PhDPrincipal InvestigatorUniversity of Connecticut
~7 spots leftby Nov 2024
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