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Completed

NCT Number: NCT02560090

Bamberg Diabetes Transitional Care Pilot Study

Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be eligible for a clinical research study to improve diabetes self-management and decrease hospital re-admissions.

The purpose of this study is to compare the effectiveness of three hospital discharge follow-up methods:

1. standard of care, 2. a nurse telephone intervention (care coordination and education), and 3. an in-home community health worker intervention (care coordination and education).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Regional Medical Center of Orangeburg and Calhoun Counties

Orangeburg, South Carolina, 29118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bamberg County resident
  • between 18 and 75 years of age
  • a patient discharged from the Regional Medical Center emergency department or Regional Medical Center hospital within 72 hours prior to consent
  • diagnosed with diabetes or at high risk for diabetes
  • will be a Regional Medical Center patient for follow-up care
  • speaks English
  • has access to a phone

Stage 2 Recruitment:

  • If recruitment at 3 weeks after the first patient is enrolled is < 15 or the recruitment at 12 weeks is < 45, additional inclusion criteria will include the following: Regional Medical Center outpatient or unassigned community member with uncontrolled diabetes (defined as A1C >8 or blood pressure >140/90) is uninsured or who self-reports problems with obtaining medications.

Exclusion criteria

  • end-stage renal disease
  • terminal illness (e.g., advanced cancer, end-stage chronic obstructive pulmonary disease, advanced dementia)
  • incarceration
  • resident in a skilled nursing home.

Treatment and study plan

Surveys

Behavioral

The following information will be collected: demographics, literacy screener, depression screener, medication adherence, self-efficacy, tobacco use, patient activation, health questionnaire, eating patterns, diabetes self-management assessment, stages of change questionnaire, vitals, and self-care behaviors.

Telephonic Nurse Intervention

Behavioral

A nurse will contact patients by phone at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.

In-person Community Health Worker

Behavioral

An in-person Community Health Worker will contact patients in-person at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.

Primary outcomes

  1. Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 1 Year After Study Completion

    Time frame: Retrospective billing collection 2 years prior to study enrollment and 1 year after study completion

    Hospital data will be obtained from Revenue and Financial Affairs South Carolina Data Oversight Council. These data come from the health organization where patients receive care and include components such as age, health care facility type, dates of admission/ discharge, length of stay, charges, payment source, primary and secondary procedure codes.

  2. Change of Self-management Success Measured by Diabetes Self-Management Assessment Survey Tool from Baseline to Study Completion

    Time frame: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)

    Diabetes self-management assessment tool administered to participant over the phone or in-person

Secondary outcomes

  1. Change of Health Goal Progress Captured by Field Notes to Track Intervention Activities from Baseline to Study Completion

    Time frame: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)

    Field Notes are completed after each interventionist's interaction with the participant to track progress to addressing health goals

  2. Change of Diet Measured By a 24-item Introduction to the Lifestyle Survey from Baseline to Study Completion

    Time frame: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)

    The 24-item Introduction to the Lifestyle Survey will be used to assess diet (fats, protein, fruits and vegetables) and at enrollment, week 4 and 12

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • North Carolina Translational and Clinical Sciences Institute
  • South Carolina Department of Health and Human Services
  • The Regional Medical Center of Orangeburg and Calhoun Counties
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Transforming Patient-Centered Medical Homes Into Medical Communities for Underserved Rural Patients

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2015
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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