最適化された糖尿病管理 (FREEDOM) のためのフードデリバリー、リモートモニタリング、およびコーチング強化教育 (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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Alabama
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Birmingham、Alabama、アメリカ、35205
- UAB Hospital and UMMC Cardiology Clinics
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：Arm 6
The participant's will not receive any Intervention |
The diabetes education class will be administered by a certified diabetes educator. |
|
アクティブコンパレータ：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
FREEDOM Study: Change in HbA1c level between baseline and 12 month
時間枠：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
時間枠：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
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。