- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02846779
Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes (TARGIT-DM)
연구 개요
상세 설명
In an era of rapidly growing healthcare costs, due to in large part to the increasing burden and complexity of chronic disease management, targeting outreach to patients who are most likely to benefit from them and tailoring interventions to individual patient needs, represent important opportunities to maximize healthcare value. The Targeted Adherence intervention to Reach Glycemic control with Insulin Therapy for patients with Diabetes (TARGIT-DM) trial is a pragmatic, intention-to-treat, randomized-controlled study that will evaluate the impact of three equivalently-priced strategies to improve insulin persistence and glycosylated hemoglobin [HbA1c] control among patients with diabetes on insulin.
The interventions in each of the three study arms will consist of educational mailings and telephonic pharmacist outreach. The pharmacists will assess and address potential barriers to insulin adherence and optimal glycemic control. The three study arms will employ differ both in regards to which patients are targeted and the intensity of the engagement strategy used. The low intensity intervention in arm 1 will be deployed to all subjects randomized to that arm. The moderate and high intensity interventions will be delivered to focused populations within arms 2 and 3, respectively, as defined by poor disease control and/or predicted risk of non-adherence. The interventions provided in the moderate and high intensity arms will also include feedback to the patient's provider, as needed, and potential enrollment in a text messaging program. Patients in these two arms who are not targeted will receive usual care.
The study population for this trial will consist of members enrolled in commercial insurance provided by Horizon Blue Cross Blue Shield of New Jersey. Insurance claims data will be used to apply the inclusion and exclusion criteria. Eligible patients will be randomized into one of three arms, stratified by baseline availability of HbA1c and a valid telephone number.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Jersey
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Newark, New Jersey, 미국, 07105-2200
- Horizon Blue Cross Blue Shield of New Jersey
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Commercially-insured individuals receiving medical and pharmacy health insurance benefits from Horizon Blue Cross Blue Shield of New Jersey
- At least 3 months of continuous enrollment prior to randomization
- At least 1 prescription for basal insulin, 6 months prior to randomization
- Type 2 diabetes diagnosis
Exclusion Criteria:
- Patients with Medicaid or Medicare as primary insurance
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Low intensity
All participants randomized to this arm will receive quarterly educational mailings and limited telephonic outreach delivered by a pharmacist focused on insulin adherence and glycemic control.
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Low intensity telepharmacy outreach
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실험적: Moderate intensity
Participants will receive all intervention components as in the low-intensity arm but will receive more frequent pharmacist follow-up and the option of enrolling in a text-messaging program.
The pharmacist will also provide limited follow-up with the participant's provider.
Only 60% of participants randomized will be targeted to receive the intervention based on adherence risk score.
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Moderate intensity telepharmacy outreach
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실험적: High intensity
Participants will receive all intervention components as in the moderate-intensity arm but will receive more frequent pharmacist follow-up.
The pharmacist will also provide more follow-up with the participant's provider and/or pharmacist.
Only 40% of participants randomized will be targeted to receive the intervention based on adherence risk score and baseline disease control.
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High intensity telepharmacy outreach
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Insulin Persistence
기간: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Percentage of participants who were non-persistent if they did not refill insulin before a set threshold of time over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Glycated Hemoglobin Level (HbA1c)
기간: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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The percent change in HbA1c level between the latest baseline value to the latest follow up value, among those with at least 1 baseline HbA1c available.
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Health Care Spending
기간: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Health care spending includes prescription medications, nondrug medical services, and the combination of these two factors over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Physician Office Visits
기간: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of all-cause physician office visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Emergency Room Visits
기간: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of all-cause emergency room visits over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of Hospitalizations
기간: From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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Number of All-cause hospitalizations over the entire follow-up period
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From 1 month (30 days) after randomization through 12 months (365 days) after randomization
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Lauffenburger JC, Lewey J, Jan S, Makanji S, Ferro CA, Krumme AA, Lee J, Ghazinouri R, Haff N, Choudhry NK. Effectiveness of Targeted Insulin-Adherence Interventions for Glycemic Control Using Predictive Analytics Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e190657. doi: 10.1001/jamanetworkopen.2019.0657. Erratum In: JAMA Netw Open. 2019 Jul 3;2(7):e198448.
- Lewey J, Wei W, Lauffenburger JC, Makanji S, Chant A, DiGeronimo J, Nanchanatt G, Jan S, Choudhry NK. Targeted Adherence Intervention to Reach Glycemic Control with Insulin Therapy for patients with Diabetes (TARGIT-Diabetes): rationale and design of a pragmatic randomised clinical trial. BMJ Open. 2017 Oct 30;7(10):e016551. doi: 10.1136/bmjopen-2017-016551.
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2016P000648
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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