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Clinic to Community Navigation to Improve Diabetes Outcomes (CCN)

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ClinicalTrials.gov Identifier: NCT03474731
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : November 11, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Nancy Schoenberg, University of Kentucky

Brief Summary:
Background and justification: Nearly 29 million Americans (9.3% of the population) have type 2 Diabetes Mellitus (T2DM) and another 86 million are considered prediabetic, 20-30% of whom will develop diabetes within five years.4,5 T2DM disproportionately affects those from lower socioeconomic status (SES) and rural backgrounds. Appalachian residents represent an extreme version of this already vulnerable population, with rates of diabetes 46% higher than national averages.6,7 The investigators have developed, pilot tested (N=41) and refined (N=48 in-depth interviews, 4 focus groups with 31 participants, and 2 CAB meetings with 16 members), a culturally appropriate, feasible, and promising intervention that combines diabetes self-management education and tailored patient navigation intervention., Goal: Our goal focuses on reducing HbA1c, BMI, blood pressure, lipids, and waist circumference and improving T2DM self-management and clinic attendance. Leveraging local assets, including faith communities, local health facilities, trained community health workers, and social support, the investigators will expand a promising and refined pilot study and assess outcomes, satisfaction and cost effectiveness. Innovation and impact: The proposed project is among the first RCT to combine the two most influential approaches to diabetes control-- self-management education and tailored patient navigation in a community setting. The Community to Clinic Navigation (CCN) intervention has the potential to sustainably empower hard to reach populations with effective self-management education and enhance the quality of healthcare in traditionally underserved communities, greatly improving T2DM outcomes.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Diabetes Self Management Program Behavioral: Tailored Patient Navigation (PN) only Behavioral: DSMP AND Tailored Patient Navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Background and justification: Nearly 29 million Americans (9.3% of the population) have type 2 Diabetes Mellitus (T2DM) and another 86 million are considered prediabetic, 20-30% of whom will develop diabetes within five years.4,5 T2DM disproportionately affects those from lower socioeconomic status (SES) and rural backgrounds. Appalachian residents represent an extreme version of this already vulnerable population, with rates of diabetes 46% higher than national averages.6,7 We have developed, pilot tested (N=41) and refined (N=48 in-depth interviews, 4 focus groups with 31 participants, and 2 CAB meetings with 16 members), a culturally appropriate, feasible, and promising intervention that combines diabetes self-management education and tailored patient navigation intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinic to Community Navigation to Improve Diabetes Outcomes
Actual Study Start Date : April 29, 2018
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2024

Arm Intervention/treatment
Experimental: Diabetes Self Management Program only
group education classes of the Diabetes Self-Management Program, (DSMP)
Behavioral: Diabetes Self Management Program

Diabetes Self Management Program (DSMP) in a group setting: The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).

Groups randomized to one of two arms (DSMP only and CCN) will receive the DSMP. The DSMP has demonstrated significant improvements in communication with physicians, healthy eating, and hypoglycemia at six and twelve months. The DSMP and other self-management programs have been shown to increase self-efficacy, knowledge, and skill building; ensure accountability/monitoring; improve patient-provider interaction; leverage local assets; address sustainability, and be cost effective.


Experimental: Tailored Patient Navigation (PN) only
assisting patients in navigation to physician offices, allowing for standard of care to follow.
Behavioral: Tailored Patient Navigation (PN) only
Tailored Patient Navigation (PN) only: The goal of this arm of the project is to try to get participants to attend their recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs. We will have to add an additional eligibility criterion for this group-they have to be out of compliance with medical appointments. Most participants will need PN services, owing to missed, rescheduled, or infrequent appointments. This means not attending their office visits, as recommended, which typically is every 3 months. We will interact with them to verify attendance and, at times, to access patient medical records if needed.

Experimental: DSMP AND Tailored Patient Navigation
Both group education classes and patient navigation
Behavioral: DSMP AND Tailored Patient Navigation
DSMP AND Tailored Patient Navigation : Both group education classes and patient navigation




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: Baseline to 18 months ]
    Changes in hemoglobin A1c (HbA1c) will be measured with a Bayer DCA 2000+ Analyzer (21), which has a test coefficient of variation < 5% consistent with requirements of the National Diabetes Data Group.


Secondary Outcome Measures :
  1. Body mass index [ Time Frame: Baseline to 18 months ]
    Change in calculated as a change in weight in kilograms divided by the square of height in meter.

  2. Waist circumference [ Time Frame: Baseline to 18 months ]
    Change in Waist circumference at the umbilical waist using the Tech-Med model cat. no. 4414.

  3. Clinic attendance [ Time Frame: Baseline to 18 months ]
    Data will be collected from clinic staff regarding participant clinic visit attendance

  4. Health related quality of life survey (HRQOL) [ Time Frame: Baseline to 18 months ]
    Changes in sociodemographics, health status and behavior, self-perceived health status, function, depression, diabetes empowerment scale, patient activation, T2DM self-management knowledge, health-related quality of life will be assessed and reported as a single HRQOL score

  5. Systolic blood pressure [ Time Frame: Baseline to 18 months ]
    Change in systolic blood pressure will be reported as the average of two sphygmomanometer readings

  6. Diastolic blood pressure [ Time Frame: Baseline to 18 months ]
    Change in diastolic blood pressure will be reported as the average of two sphygmomanometer readings

  7. High density lipoprotein (HDL) [ Time Frame: Baseline to 18 months ]
    blood will be drawn and HDL will be measured using a Cholestech LDX point of care machine. Data will be reported as the change in HDL over 18 months

  8. Low density lipoprotein (LDL) [ Time Frame: Baseline to 18 months ]
    blood will be drawn and LDL will be measured using a Cholestech LDX point of care machine. Data will be reported as the change in LDL over 18 months

  9. Total cholesterol [ Time Frame: Baseline to 18 months ]
    blood will be drawn and Total cholesterol will be measured using a Cholestech LDX point of care machine. Data will be reported as the change in total cholesterol over 18 months



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults (age 18+);
  • Appalachian residence, no plans to relocate out of the area in the next 18 months,
  • Willingness and ability to participate (i.e., no major cognitive impairment)
  • HbA1c levels at least 6.5% or Diagnosis of Diabetes.

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03474731


Contacts
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Contact: Jennifer Malan 606 633 3339 jennifer.malan@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Nancy Schoenberg, PhD    859-323-8175    nesch@uky.edu   
Contact: Jennifer Malan    859 633-3339    jennifer.malan@uky.edu   
Principal Investigator: Nancy Schoenberg, PhD         
Sub-Investigator: Laura Hieronymus, DNP         
Sub-Investigator: Roberto Cardarelli         
Sub-Investigator: Brittany Smalls, PhD, MHSA         
Sub-Investigator: Frances Feltner, DNP         
Sub-Investigator: Glen Mays         
Sub-Investigator: Richard Charnigo, PhD         
Sponsors and Collaborators
Nancy Schoenberg
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Nancy Schoenberg, PhD University of Kentucky
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nancy Schoenberg, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03474731    
Other Study ID Numbers: 14-0314-P6H
R01DK112136 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases