DiabetesNCT02560090
Bamberg Diabetes Transitional Care Pilot Study
A study testing Surveys, Telephonic Nurse Intervention and In-person Community Health Worker in people with Diabetes, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Surveys, Telephonic Nurse Intervention and In-person Community Health Worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 1 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Regional Medical Center of Orangeburg and Calhoun Counties
Orangeburg, South Carolina, 29118
About this study
Official title: Transforming Patient-Centered Medical Homes Into Medical Communities for Underserved Rural Patients
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:
- standard of care,
- a nurse telephone intervention (care coordination and education), and
- an in-home community health worker intervention (care coordination and education).
- Conditions
- Diabetes
- Being tested
- Surveys, Telephonic Nurse Intervention, In-person Community Health Worker
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysBehavioural
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 InterventionBehavioural
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 WorkerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Survey assessments as well as collection of medical records and billing information. Receives: 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. Receives: 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. Receives: Behavioral: Surveys; Behavioral: In-person Community Health Worker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Field Notes are completed after each interventionist's interaction with the participant to track progress to addressing health goals
Measured: 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
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
Measured: Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start1 Jun 2015
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, South Carolina Department of Health and Human Services, North Carolina Translational and Clinical Sciences Institute, The Regional Medical Center of Orangeburg and Calhoun Counties
- Responsible party
- Sponsor
- Investigators
- Carolyn Jenkins, DrPh, MSN, Principal investigator, Medical University of South CarolinaSamuel Cykert, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560090
- Sponsor's protocol ID
- Pro00038334
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2015
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Patient-Centered Medical Homes Into Medical Communities for Underserved Rural Patients
- ClinicalTrials.gov ID
- NCT02560090
- Acronym / sponsor ID
- Pro00038334
- Conditions
- Diabetes
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, South Carolina Department of Health and Human Services, North Carolina Translational and Clinical Sciences Institute, The Regional Medical Center of Orangeburg and Calhoun Counties
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- standard of care,
- a nurse telephone intervention (care coordination and education), and
- an in-home community health worker intervention (care coordination and education).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: SurveysSurvey assessments as well as collection of medical records and billing information. |
| Telephonic Nurse Intervention | Active comparator | Behavioral: Surveys, Behavioral: Telephonic 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 Intervention | Active comparator | Behavioral: Surveys, Behavioral: In-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysThe 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. | Behavioural | Control Group, In-person Community Health Worker Intervention, Telephonic Nurse Intervention |
| Telephonic Nurse InterventionA 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. | Behavioural | Telephonic Nurse Intervention |
| In-person Community Health WorkerAn 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. | Behavioural | In-person Community Health Worker Intervention |
Primary outcome
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.
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
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Jenkins, DrPh, MSN principal investigator
Medical University of South Carolina
Samuel Cykert, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys, Telephonic Nurse Intervention and In-person Community Health Worker in people with Diabetes, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.