Bamberg Diabetes Transitional Care Pilot Study

NCT02560090 | Completed

• 1 other identifier: Pro00038334
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (2)

• Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 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.

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

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

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

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Survey assessments as well as collection of medical records and billing information.

Behavioral: Surveys

Telephonic Nurse Intervention

ACTIVE COMPARATOR

Survey assessments as well as collection of medical records and billing information. A nurse will communicate with participants via telephone to support diabetes self-management practices.

Behavioral: Surveys; Behavioral: Telephonic Nurse Intervention

In-person Community Health Worker Intervention

ACTIVE COMPARATOR

Survey assessments as well as collection of medical records and billing information. A community health worker will work with participants in person to support diabetes self-management practices.

Behavioral: Surveys; Behavioral: In-person Community Health Worker

Interventions

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.

Control Group; In-person Community Health Worker Intervention; Telephonic Nurse Intervention

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.

Telephonic Nurse Intervention

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.

In-person Community Health Worker Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The Regional Medical Center of Orangeburg and Calhoun Counties

Orangeburg, South Carolina, 29118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Carolyn Jenkins, DrPh, MSN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Samuel Cykert, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: September 25, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (1)