- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01960062
Impact of Web-based Care Management for Poorly Controlled Type 2 Diabetes Mellitus: a Randomized, Controlled Trial
연구 개요
상세 설명
Diabetes is an increasingly important public health issue. The American Diabetes Association estimates that 25.8 million people in the United States (8% of the total population) currently have diabetes. In fact, it is estimated that as many as 30.3 million Americans will have the disease by the year 2030. Concurrently, the economic impact of diabetes is rising at an alarming rate. In 2007, all costs associated with diabetes totaled $174 billion; $116 billion was spent on direct medical costs. Diabetes is associated with significant morbidity and mortality, a leading cause of blindness, kidney failure, stroke, and cardiovascular death.
Given the chronically progressive nature of diabetes, controlling the disease and preventing or delaying complications necessitates constant communication between the patient and the provider. Diabetes care limited to clinic visits does not meet the needs of many patients. With the increasing diabetes burden, there is an unmet need for innovative care methods. The internet's widespread availability has paved the way for increased utilization of web-based care management programs to manage chronic diseases such as diabetes mellitus.
A few randomized controlled trials have evaluated the use of web-based care in diabetes. These trials, ranging from 3 months to 30 months, have shown favorable changes in Hemoglobin A1c (HbA1c), as well as patient and provider satisfaction. A web-based application called MyLink has been used and evaluated in some Kaiser Permanente regions with impressive differences in HbA1c between groups utilizing web-based care versus usual care. This tool, along with appropriate software, enables patients to upload glucometer results from home, to the care provider in the office. Patients are able to view trends on their computer screen to see how lifestyle activities affect their blood sugar. The primary objective of this study is to evaluate the potential role of the MyLink web-based care management program in improving diabetes-related measures. It is expected that participants using web-based care will achieve a greater improvement in HbA1c than patients receiving usual care from the Clinical Pharmacy Specialist (CPS).
Between October 1 and November 30, 2011, participants will be enrolled in this study comparing the use of MyLink web-based care with usual CPS care. Patients age 18- 74 with HbA1c ≥ 9% in the last 12 months will be identified. It is expected that approximately 32 people (16 per group) will participate in the study. Once eligible patients are found, they will be randomly assigned (like the flip of a coin) to usual care with the CPS or usual care with the CPS plus web-based care using the MyLink software. Participants using the software will agree to upload their glucometer measurements using the software every 2- 4 weeks. Following the receipt of the glucometer data, either electronically from intervention group participants or verbally from the control group participants, medications/ doses will be adjusted by the pharmacist as needed to achieve HbA1c goals. Participants in both groups will receive a follow-up HbA1c 2-4 months after enrollment to see if there were any significant changes in HbA1c between groups.
연구 유형
단계
- 해당 없음
연락처 및 위치
연구 장소
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Georgia
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Atlanta, Georgia, 미국, 30305
- Kaiser Permanente Georgia Region
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Receiving care from a PCP at the specified KPGA medical centers
- 18-74 years of age
- Type 2 Diabetes Mellitus (DM)
- Treated with insulin or willing to start insulin therapy
- Most recent HbA1c in the previous 12 months ≥ 9%
- Internet capability
- Actively enrolled or willing to enroll on www.kp.org
- English speaking
Exclusion Criteria:
- Having received care from an endocrinology specialty physician or Hospice/ Palliative Care within the last 3 months
- Enrolled in another research study
- Using an insulin pump
- Type 1 DM
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control
Diabetes care with primary care practitioner supplemented with clinical pharmacy specialist
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실험적: Intervention
Diabetes care with primary care practitioner and clinical pharmacy specialist, with the aid of a diabetes software and device to upload glucometer results from home
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USB cord, CD-rom, and application to allow communication with provider
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Change in Hemoglobin A1c
기간: 2-4 months
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2-4 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Hemoglobin A1c<9
기간: 2-4 months
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2-4 months
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Office visit time
기간: 2-4 months
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time spent with participants during office visit
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2-4 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Naomi Yates, PharmD, Kaiser Permanente
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. .
제2형 당뇨병에 대한 임상 시험
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