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Diabetes Self-Management + Patient Navigation for Diabetes (CCN Trial)

N/A

Waitlist Available

Led By Nancy Schoenberg, PhD

Research Sponsored by Nancy Schoenberg

Eligibility Criteria Checklist

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

Must have

HbA1c levels at least 6.5% or Diagnosis of Diabetes

Willingness and ability to participate (i.e., no major cognitive impairment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 18 months

Awards & highlights

CCN Trial Summary

This trial will test a diabetes self-management education and patient navigation intervention to see if it can reduce HbA1c, BMI, blood pressure, lipids, and waist circumference and improve T2DM self-management and clinic attendance in Appalachian residents.

Who is the study for?

This trial is for adults with diabetes or HbA1c levels of at least 6.5%, living in the Appalachian region, who are willing and able to participate without major cognitive impairments and no plans to move away within the next 18 months.Check my eligibility

What is being tested?

The study tests a combination of a Diabetes Self-Management Program (DSMP) and Tailored Patient Navigation (PN), comparing it against each intervention alone. The goal is to improve diabetes control and self-management in underserved communities.See study design

What are the potential side effects?

Since this trial focuses on education and navigation programs rather than medications, traditional side effects are not expected; however, participants may experience stress or time constraints due to program involvement.

CCN Trial Eligibility Criteria

Inclusion Criteria

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

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My HbA1c level is 6.5% or higher, or I have been diagnosed with diabetes.

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I am mentally capable and willing to participate in the trial.

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I am 18 years old or older.

CCN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 18 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

Hemoglobin A1c

Secondary outcome measures

Body mass index

Clinic attendance

Diastolic blood pressure

+6 more

CCN Trial Design

3Treatment groups

Experimental Treatment

Group I: Tailored Patient Navigation (PN) onlyExperimental Treatment1 Intervention

assisting patients in navigation to physician offices, allowing for standard of care to follow.

Group II: Diabetes Self Management Program onlyExperimental Treatment1 Intervention

group education classes of the Diabetes Self-Management Program, (DSMP)

Group III: DSMP AND Tailored Patient NavigationExperimental Treatment1 Intervention

Both group education classes and patient navigation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diabetes Self Management Program

2013

N/A

~1000

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nancy SchoenbergLead Sponsor

4 Previous Clinical Trials

3,360 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,356 Previous Clinical Trials

4,314,367 Total Patients Enrolled

107 Trials studying Diabetes

138,663 Patients Enrolled for Diabetes

Nancy Schoenberg, PhDPrincipal Investigator - University of Kentucky

University of Kentucky

Media Library

Diabetes Self Management Program Clinical Trial Eligibility Overview. Trial Name: NCT03474731 — N/A

Diabetes Research Study Groups: DSMP AND Tailored Patient Navigation, Tailored Patient Navigation (PN) only, Diabetes Self Management Program only

Diabetes Clinical Trial 2023: Diabetes Self Management Program Highlights & Side Effects. Trial Name: NCT03474731 — N/A

Diabetes Self Management Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT03474731 — N/A

Frequently Asked Questions

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

What is the participant limit of this research project?

"Affirmative. According to clinicaltrials.gov, this investigation is currently recruiting volunteers and was initially announced on April 29th 2018. It has most recently been updated on November 16th 2022 and the team requires 1,200 participants from one site."

Answered by AI

Are there any opportunities to join this medical experiment at present?

"Affirmative. Clinicaltrials.gov reveals that this experiment, which was initially announced on April 29th 2018, is now open to new participants. 1 centre needs to enlist a total of 1200 patients for the trial's completion."

Answered by AI

Can seniors aged 65 and above participate in this investigation?

"This clinical trial is recruiting individuals aged 18 and above, up to 99 years old."

Answered by AI

What are the eligibility criteria for participation in this clinical trial?

"Applicants to this clinical trial must have a diagnosis of diabetes mellitus and be aged between 18 and 99. Around 1200 participants are being sought after."

Answered by AI

Recent research and studies

BMC Public HealthJournal

The Mediating/moderating Role of Cultural Context Factors on Self-care Practices Among Those Living with Diabetes in Rural Appalachia

Smalls, Brittany L., Adebola Adegboyega, Ellen Combs, Matthew Rutledge, Philip M. Westgate, Md. Tofial Azam, Felipe De La Barra, Lovoria B. Williams, and Nancy E. Schoenberg. 2021. “The Mediating/moderating Role of Cultural Context Factors on Self-care Practices Among Those Living with Diabetes in Rural Appalachia”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-021-11777-7.

clinicaltrials.govStudy

Clinic to Community Navigation to Improve Diabetes Outcomes

Nancy Schoenberg 2018. "Clinic to Community Navigation to Improve Diabetes Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03474731.