Latinos Understanding the Need for Adherence in Diabetes (LUNA-D)
2019년 6월 10일 업데이트: Gregory Talavera, San Diego State University
The Latinos Understanding the Need for Adherence in Diabetes (LUNA-D) study, is a randomized controlled trial testing the effectiveness of an integrated behavioral health and primary care chronic care disease management intervention for low income Latino patients with type-2 diabetes mellitus (T2DM) that have 2 or more chronic health conditions.
LUNA-D focuses on diabetes management and behavioral health care integration.
연구 개요
상세 설명
LUNA-D proposes to test the ability of a fully integrated behavioral health and primary care diabetes management intervention in a federally-qualified community health care setting to improve multiple clinical and behavioral outcomes.
LUNA-D will recruit non-insulin using adult type two diabetes mellitus (T2DM) patients with two or more chronic diseases.
Half will be randomized to the Special Intervention (SI) arm and half to the Usual Care (UC) arm.
The SI is an intensive intervention including fully integrated clinical visits with a medical provider (MP) co-located with a behavioral health counselor (BHC) and peer-led evidence-based group health education sessions and proactive care coordination.
Usual Care is represented by passive appointments with the primary care physician and passive referrals to behavioral health and traditional health education.
Biological measurements will be taken at baseline, 3-, 6-, 9- and 12-months to detect changes in glycemic control.
Clinical lab measures, medication adherence, weight, health behaviors and psychosocial measures will also be obtained across the study.
연구 유형
중재적
등록 (실제)
456
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Chula Vista, California, 미국, 91910
- South Bay Latino Research Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
This study targets non-insulin using T2DM patients with 2 or more chronic conditions. The primary eligibility criteria are as follows:
- Self-identify as Hispanic/Latino
- Be a registered & established patient of SYH
- 18 years of age or older
- Have an established diagnosis of T2DM (but not currently using insulin)
- Not currently participating in any other diabetes or CVD intervention program
- Have 2 or more CVD risk factors (e.g., depression, anxiety, hypertension, dyslipidemia, obesity, or smoking)
Exclusion Criteria:
Individuals will be excluded if they:
- Are pregnant or planning to get pregnant (temporary exclusion, may qualify 6-months postpartum)
- Have plans to move out of the area in the next 12 months
- Have pre-existing health problems so severe as to prohibit informed consent and study attendance
- Have severe diabetes, including renal disease and/or on dialysis
- Have severe psychosocial conditions under the care of a psychiatrist (e.g., severe depression, bipolar disorder, or schizophrenia)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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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실험적: Special Intervention
The special intervention (SI) arm addresses glycemic control, medication adherence, control of modifiable CVD risk factors, health behavior change, and psychosocial and cultural barriers to self-management.
The SI arm consists of a collaborative care team approach with four main elements including: 1) Specialized clinical care by a medical provider; 2) Specialized behavioral health care by a behavioral health provider; 3) Group-based chronic disease self-management education by peer-leaders; 4) Intensive, proactive care coordination facilitated by a patient registry and electronic health records.
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The components of the Special Intervention (SI) integrated design are: 1) Co-location of the clinical team; 2) Shared medical plan; 3) Clinical visits with a medical provider for management of chronic medical conditions; 4) Visits with behavioral health provider for management of psychosocial chronic conditions; 5) Care coordination; 6) Six group-health education classes and two booster sessions led by a promotora.
Participants in the SI arm meet with the integrated care team in the context of a regular medical visit primarily to focus on clinical/biological aspects of the chronic medical conditions (diabetes, dyslipidemia, hypertension, obesity, etc.)
다른 이름들:
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간섭 없음: Usual Care
Participants randomized to the Usual Care (UC) arm continue to see their primary care provider and receive referrals to health education.
At the discretion of the provider, UC patients are screened and referred to behavioral health (BH) care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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HbA1c Blood Value
기간: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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The primary outcome is change in HbA1c values among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
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Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Body Mass Index (BMI)
기간: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Lower BMI among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
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Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Total Cholesterol
기간: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Lower cholesterol levels among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
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Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Blood Pressure (BP)
기간: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Improve the ratio of systolic to diastolic blood pressure among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
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Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Patient Health Questionnaire (PHQ-8)
기간: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Improve depression symptomatology among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
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Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Generalized Anxiety Disorder 7-item (GAD-7)
기간: Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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Improve anxiety symptomatology among non-insulin using type 2 diabetes mellitus Latino patients through a linguistically and culturally appropriate evidence-based application of a Chronic Care Model (LUNA-D).
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Repeated measures will be taken at baseline, 3-, 6-, 9-, 12-months post randomization in order to compare the rates of change over time between the two conditions (SI and UC).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Gregory A Talavera, MD/MPH, SDSU
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Castaneda SF, Gallo LC, Garcia ML, Mendoza PM, Gutierrez AP, Lopez-Gurolla M, Roesch S, Pichardo MS, Munoz F, Talavera GA. Effectiveness of an integrated primary care intervention in improving psychosocial outcomes among Latino adults with diabetes: the LUNA-D study. Transl Behav Med. 2022 Aug 17;12(8):825-833. doi: 10.1093/tbm/ibac042. Erratum In: Transl Behav Med. 2022 Sep 28;:
- Talavera GA, Castaneda SF, Mendoza PM, Lopez-Gurrola M, Roesch S, Pichardo MS, Garcia ML, Munoz F, Gallo LC. Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. Transl Behav Med. 2021 Sep 15;11(9):1665-1675. doi: 10.1093/tbm/ibab052.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 7월 16일
기본 완료 (실제)
2018년 12월 18일
연구 완료 (실제)
2018년 12월 31일
연구 등록 날짜
최초 제출
2019년 6월 7일
QC 기준을 충족하는 최초 제출
2019년 6월 10일
처음 게시됨 (실제)
2019년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 6월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 6월 10일
마지막으로 확인됨
2019년 6월 1일
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. .