Southeastern Diabetes Initiative Clinical Intervention (SEDI)
A Clinical Intervention to Serve High-Risk Patients in the Southeastern Diabetes Initiative and Durham Diabetes Coalition
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Mississippi
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Madison, Mississippi, 미국
- Mississippi Public Health Institute
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North Carolina
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Durham, North Carolina, 미국
- Durham County Department of Public Health
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Kannapolis, North Carolina, 미국
- Cabarrus Health Alliance
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West Virginia
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Williamson, West Virginia, 미국
- Williamson Health and Wellness Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: High Risk group
Extension of Care
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Mortality
기간: Up to 24 months
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Up to 24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of health services utilization
기간: up to 24 months
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As measured by inpatient hospital admissions and emergency department visits
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up to 24 months
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Change in Medication Adherence
기간: 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
기간: 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
기간: 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
기간: 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 pressure
기간: 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
기간: Up to 24 months
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Includes retinopathy, neuropathy, kidney disease, cardiovascular disease
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Up to 24 months
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Change in patient-reported outcomes
기간: Baseline, 6, 12, 18, and 24 months
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Includes results from PHQ 2, PAM-13, PROMIS 9, and REALM-SF surveys
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Baseline, 6, 12, 18, and 24 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Robert Califf, MD, Duke Translational Medicine Institute
- 수석 연구원: Bryan Batch, MD, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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