Southeastern Diabetes Initiative Clinical Intervention (SEDI)
A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
調査の概要
詳細な説明
Clinical care will be delivered by a multidisciplinary team including (but not limited to) an physician, nurse practitioner, dietician, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker. Care will be delivered in community settings including home visits and community based clinics. With the exception of specific surveys (listed in the Study Intervention section) all data are being collected for the purpose of delivery of standard preventive care and clinical care. The population group will include patients diagnosed with Type 2 Diabetes Mellitus in four Southern United States counties, meeting certain inclusion criteria, and deemed "high risk" as determined by a set of standard criteria or a risk algorithm run on secondary data.
The investigators plan to characterize patients diagnosed or at risk for diabetes mellitus, and allow more detailed knowledge of their health than is provided by standard public health data. The investigators will use descriptive, parametric and non-parametric statistics to describe baseline characteristics (demographics and clinical measures of disease severity) of the sample and will compare responders and dropouts on independent and dependent variables, report any significant differences, and include this in the interpretation of results.
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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Mississippi
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Madison、Mississippi、アメリカ
- Mississippi Public Health Institute
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North Carolina
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Durham、North Carolina、アメリカ
- Durham County Department of Public Health
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Kannapolis、North Carolina、アメリカ
- Cabarrus Health Alliance
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West Virginia
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Williamson、West Virginia、アメリカ
- Williamson Health and Wellness Center
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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:
- Adults >=18yrs
- Diagnosis of Type 2 diabetes
- Reside in Durham County, NC, Cabarrus County, NC, Quitman County, MS or Mingo County, WV or the neighboring areas and receive the majority of their healthcare in the four listed counties.
- Have capacity to give consent (or have a surrogate legally authorized representative or caregiver provide consent on their behalf).
- Defined as high risk by the risk algorithm or their primary care clinician.
- Referral from the primary care clinician or patient's medical home if one has been designated.
Exclusion Criteria:
- Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
- Have a terminal illness with a life expectancy of 6 months or less
- Diagnosis of Type 1 diabetes or gestational diabetes
- Currently pregnant (confirmed via self-report and/or medical record)
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：High Risk group
Extension of Care
|
Clinical care will be delivered by a multidisciplinary team including (but not limited to) a physician, nurse practitioner, dietitian, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker in community settings including home visits and community based clinics.
|
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 |
時間枠 |
|---|---|
|
Mortality
時間枠：Up to 24 months
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Up to 24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of health services utilization
時間枠：up to 24 months
|
As measured by inpatient hospital admissions and emergency department visits
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up to 24 months
|
|
Change in Medication Adherence
時間枠：Baseline, 6, 12, 18, and 24 months
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As measured by the Morisky Medication Adherence Score
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Baseline, 6, 12, 18, and 24 months
|
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Change in HbA1c
時間枠：Baseline, 6, 12, 18, and 24 months
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Baseline, 6, 12, 18, and 24 months
|
|
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Change in blood lipids
時間枠：Baseline, 6, 12, 18, and 24 months
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Measurements include total cholesterol, HDL, LDL, triglycerides
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Baseline, 6, 12, 18, and 24 months
|
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Change in blood glucose
時間枠：Baseline, 6, 12, 18, and 24 months
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Baseline, 6, 12, 18, and 24 months
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|
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Change in blood pressure
時間枠：Baseline, 6, 12, 18, and 24 months
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Baseline, 6, 12, 18, and 24 months
|
|
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Incidence of micro- and macro-vascular complications
時間枠：Up to 24 months
|
Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
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Up to 24 months
|
|
Change in patient-reported outcomes
時間枠：Baseline, 6, 12, 18, and 24 months
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Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
|
Baseline, 6, 12, 18, and 24 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Robert Califf, MD、Duke Translational Medicine Institute
- 主任研究者：Bryan Batch, MD、Duke University
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
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