최적화된 당뇨병 관리를 위한 음식 배달, 원격 모니터링 및 코칭 강화 교육(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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Detailed Description:
-
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35205
- UAB Hospital and UMMC Cardiology Clinics
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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. |
|
활성 비교기: 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. |
|
활성 비교기: 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. |
|
활성 비교기: 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. |
|
활성 비교기: Arm 6
The participant's will not receive any Intervention |
The diabetes education class will be administered by a certified diabetes educator. |
|
활성 비교기: 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. |
|
활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
FREEDOM Study: Change in HbA1c level between baseline and 12 month
기간: 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
|
|
Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- IRB-300008387
- 5P50MD017338-03 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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