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Bamberg Diabetes Transitional Care Pilot Study

Not Applicable
Completed
Conditions
Diabetes
Interventions
Behavioral: Surveys
Behavioral: In-person Community Health Worker
Behavioral: Telephonic Nurse Intervention
Registration Number
NCT02560090
Lead Sponsor
Medical University of South Carolina
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. 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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control GroupSurveysSurvey assessments as well as collection of medical records and billing information.
In-person Community Health Worker InterventionIn-person Community Health WorkerSurvey 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.
Telephonic Nurse InterventionSurveysSurvey 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.
Telephonic Nurse InterventionTelephonic Nurse InterventionSurvey 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.
In-person Community Health Worker InterventionSurveysSurvey 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.
Primary Outcome Measures
NameTimeMethod
Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 1 Year After Study CompletionRetrospective 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.

Change of Self-management Success Measured by Diabetes Self-Management Assessment Survey Tool from Baseline to Study CompletionBaseline, 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 Outcome Measures
NameTimeMethod
Change of Diet Measured By a 24-item Introduction to the Lifestyle Survey from Baseline to Study CompletionBaseline, 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

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

Trial Locations

Locations (1)

The Regional Medical Center of Orangeburg and Calhoun Counties

🇺🇸

Orangeburg, South Carolina, United States

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