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Diabetes Self-Management Education for Reproductive-Aged Women With Type 2 Diabetes (PREPARED Trial)

N/A

Recruiting

Led By Stacy Bailey, PhD MPH

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Age 18-44

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month and 3 months

Awards & highlights

PREPARED Trial Summary

This trial is testing different ways to teach patients about type 2 diabetes and how to take care of themselves during their reproductive years.

Who is the study for?

This trial is for women aged 18-44 with type 2 diabetes who are not currently pregnant, can get pregnant, and aren't in a relationship with someone unable to have children. They must speak English or Spanish, be able to consent, and have a private cell phone that can send texts.Check my eligibility

What is being tested?

The study tests if certain tools like provider alerts, decision support systems, medication reconciliation tools (MedRec), PREPSheets for planning pregnancy care, and text messaging improve knowledge and self-care in reproductive-aged women with type 2 diabetes.See study design

What are the potential side effects?

Since this trial involves educational tools rather than medications or invasive procedures, side effects may include discomfort from frequent communication or potential privacy concerns related to text messaging.

PREPARED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am between 18 and 44 years old.

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I have been diagnosed with type 2 diabetes.

PREPARED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average difference in HbA1c values between Intervention and Control Patients

Knowledge of reproductive risks

Secondary outcome measures

Average difference in blood pressure values between Intervention and Control Patients

Average difference in cholesterol values between Intervention and Control Patients

Contraceptive use

+2 more

PREPARED Trial Design

2Treatment groups

Active Control

Group I: PREPARED StrategyActive Control4 Interventions

Our PREPARED strategy will utilize health information and consumer technologies to 'hardwire' preconception care and promote diabetes self-management among reproductive-aged, adult women with T2DM in primary care. PREPARED will leverage electronic health record technology at clinic visits to: [1] promote medication reconciliation and safety, [2] prompt provider preconception counseling, and [3] deliver low literacy print tools to reinforce counseling and promote diabetes self-care. Post-visit, text messaging will be used to: [4] encourage healthy lifestyle behaviors.

Group II: Usual CareActive Control1 Intervention

Usual care includes: 1) no specific materials to promote medication reconciliation, reproductive planning, or patient education on diabetes self-management within the context of preconception care, 2) variable physician preconception counseling without any EHR notifications or counseling support; and 3) no specific patient support or prompts to promote healthy behaviors post-visits.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,589 Previous Clinical Trials

916,286 Total Patients Enrolled

Northwestern Memorial HospitalOTHER

40 Previous Clinical Trials

15,876 Total Patients Enrolled

AllianceChicagoOTHER

6 Previous Clinical Trials

16,341 Total Patients Enrolled

Media Library

PREPARED Strategy Clinical Trial Eligibility Overview. Trial Name: NCT04976881 — N/A

Type 2 Diabetes Research Study Groups: PREPARED Strategy, Usual Care

Type 2 Diabetes Clinical Trial 2023: PREPARED Strategy Highlights & Side Effects. Trial Name: NCT04976881 — N/A

PREPARED Strategy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04976881 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled spots available in this research project?

"According to clinicaltrials.gov, this trial is currently recruiting individuals for participation. It was initially posted on February 11th 2022 and the entry data has been modified as recently as May 11th of that same year."

Answered by AI

Does this study allow seniors to participate?

"This medical experiment is open to those aged 18 and up, but not exceeding 44 years of age."

Answered by AI

To what extent is patient participation in this experiment being observed?

"Correct. Clinicaltrials.gov hosts information that confirms this medical trial is currently enrolling participants, which began on the 11th of February 2022 and was recently updated on the 11th May 2022. 840 patients will be recruited from 1 site for this research project."

Answered by AI

Is it possible to partake in this medical experiment?

"This investigation requires 840 participants, between the ages of 18 and 44 years old with a diagnosis of diabetes mellitus type 2. In addition to this core criteria, potential candidates must not be pregnant or infertile, have undergone sterilization procedures, or in a monogamous relationship with another sterilized individual; they should also own a private cellular device that supports text messaging."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes

Stacy C Bailey 2022. "Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04976881.

All > Diabetes Type 2