Dostawa żywności, zdalne monitorowanie i wspomagana coachingiem edukacja w celu zoptymalizowania zarządzania cukrzycą (FREEDOM) (FREEDOM)
Brief Summary:
The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.
Przegląd badań
Status
Warunki
Szczegółowy opis
Detailed Description:
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FREEDOM Study (Type 2 Diabetes Mellitus):
The FREEDOM study is a 12-month clinical trial enrolling 304 Black adults with Type 2 Diabetes Mellitus across three healthcare systems in Alabama and Mississippi. Participants are randomly assigned to one of eight combinations of three intervention components:
- Digital Health Coaching: Participants receive one-on-one phone-based coaching for optimized diabetes management.
- Food Box Delivery: Food boxes are delivered every two weeks to participants' homes,
- Remote Patient Monitoring (RPM): Participants receive essential supplies, including glucometers, for remote blood glucose measurement. Data is monitored remotely for timely interventions.
The study involves three in-person visits at baseline, month 6, and month 12, as well as two telephone study check-ins at month 3 and 9. Survey packets are administered at each time point.
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FREEDOM-HIV Study (Type 2 Diabetes Mellitus and HIV Cohort):
Additionally, a cohort within the study, known as the FREEDOM-HIV study, will enroll additional 80 adults who have both Type 2 Diabetes Mellitus and HIV. This cohort will be observed over a 6-month period and will also consist of the same three intervention components.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35205
- UAB Hospital and UMMC Cardiology Clinics
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion criteria:
- Self-identified as Black/African American
- ICD diagnosis of T2DM
- ≥18 years of age
- Ongoing insulin treatment
- HbA1c ≥8% within 6 weeks of study screening
- has the ability to converse in and read English
- must provide written informed consent prior to enrollment
Exclusion criteria:
- Current enrollment in any diabetes-related interventional study
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
- Currently enrolled in a structured lifestyle change program
- Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
HIV Cohort Criteria
Inclusion Criteria
- ≥ 18 years of age
- ICD diagnosis of T2DM
- HbA1c ≥ 7%
- Confirmed HIV+ diagnosis
- Prescribed HIV ART therapy as part of care
Exclusion Criteria
- Current enrollment in any diabetes-related interventional study or structured lifestyle change program
- Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przypisanie czynnikowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arm 1
Digital coaching+ Food delivery+ RPM |
The digital health coaching intervention program involves an evidence-based curriculum and one-on-one support to promote positive health behaviors and patient self-management of diabetes. The food box intervention component will consist of biweekly food boxes delivered directly to participants over the course of 6 months. The food boxes will contain shelf-stable groceries that adhere to ADA nutritional guidelines for individuals with T2DM. The RPM team will instruct the participants to monitor blood glucose levels 3 times daily. Glucose levels will be monitored 8 a.m. to 5 p.m.Monday to Friday. Data summaries will be reviewed bi-monthly with RNs and pharmacists. Participants will be provided with a glucometer, test strips, and mobile divide to record their blood glucose levels. The diabetes education class will be administered by a certified diabetes educator. |
|
Aktywny komparator: Arm 2
Digital coaching |
The digital health coaching intervention program involves an evidence-based curriculum and one-on-one support to promote positive health behaviors and patient self-management of diabetes. The diabetes education class will be administered by a certified diabetes educator. |
|
Aktywny komparator: Arm 3
Digital coaching+ Food delivery |
The digital health coaching intervention program involves an evidence-based curriculum and one-on-one support to promote positive health behaviors and patient self-management of diabetes. The food box intervention component will consist of biweekly food boxes delivered directly to participants over the course of 6 months. The food boxes will contain shelf-stable groceries that adhere to ADA nutritional guidelines for individuals with T2DM. The diabetes education class will be administered by a certified diabetes educator. |
|
Aktywny komparator: Arm 4
Digital coaching+ RPM |
The digital health coaching intervention program involves an evidence-based curriculum and one-on-one support to promote positive health behaviors and patient self-management of diabetes. The RPM team will instruct the participants to monitor blood glucose levels 3 times daily. Glucose levels will be monitored 8 a.m. to 5 p.m.Monday to Friday. Data summaries will be reviewed bi-monthly with RNs and pharmacists. Participants will be provided with a glucometer, test strips, and mobile divide to record their blood glucose levels. The diabetes education class will be administered by a certified diabetes educator. |
|
Aktywny komparator: Arm 5
Food delivery+ RPM |
The food box intervention component will consist of biweekly food boxes delivered directly to participants over the course of 6 months. The food boxes will contain shelf-stable groceries that adhere to ADA nutritional guidelines for individuals with T2DM. The RPM team will instruct the participants to monitor blood glucose levels 3 times daily. Glucose levels will be monitored 8 a.m. to 5 p.m.Monday to Friday. Data summaries will be reviewed bi-monthly with RNs and pharmacists. Participants will be provided with a glucometer, test strips, and mobile divide to record their blood glucose levels. The diabetes education class will be administered by a certified diabetes educator. |
|
Aktywny komparator: Arm 6
The participant's will not receive any Intervention |
The diabetes education class will be administered by a certified diabetes educator. |
|
Aktywny komparator: Arm 7
Food delivery |
The food box intervention component will consist of biweekly food boxes delivered directly to participants over the course of 6 months. The food boxes will contain shelf-stable groceries that adhere to ADA nutritional guidelines for individuals with T2DM. The diabetes education class will be administered by a certified diabetes educator. |
|
Aktywny komparator: Arm 8
RPM |
The RPM team will instruct the participants to monitor blood glucose levels 3 times daily. Glucose levels will be monitored 8 a.m. to 5 p.m.Monday to Friday. Data summaries will be reviewed bi-monthly with RNs and pharmacists. Participants will be provided with a glucometer, test strips, and mobile divide to record their blood glucose levels. The diabetes education class will be administered by a certified diabetes educator. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
FREEDOM Study: Change in HbA1c level between baseline and 12 month
Ramy czasowe: 12 months
|
The primary outcome of the study is to track change in the HbA1c between baseline and 12 months (endpoint of the study). The HbA1C will be tested at baseline, 6 and 12 months. |
12 months
|
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Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
Ramy czasowe: 6 months
|
The primary outcome of the study is to track change in the HbA1c between baseline and 6 months (endpoint of the study). The HbA1C will be tested at baseline and 6 months. |
6 months
|
Współpracownicy i badacze
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-300008387
- 5P50MD017338-03 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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