Implementation Support for HEARTS-Based Hypertension and Diabetes Care in Guatemala (MULTI-HEARTS)
Cluster-Randomized Trial of Implementation Support for HEARTS-Based Care Among Adults With Hypertension and Diabetes in Guatemala (MULTI-HEARTS)
The purpose of this study is to find out whether extra support for a program called HEARTS can improve care for people who have both high blood pressure and diabetes. HEARTS was created by the World Health Organization to help primary care health centers deliver better treatment. It is the official model for high blood pressure and diabetes care in Guatemala's Ministry of Health. In this study, 36 Ministry of Health health centers in Guatemala will be randomly assigned to 1 of 2 groups. Health centers in both groups will use HEARTS through the Ministry of Health's routine training, treatment guides, and digital tools. Health centers in 1 group will also receive 36 months of extra support from the Institute of Nutrition of Central America and Panama (INCAP). This support includes refresher training for health workers every 6 months, monthly supportive supervision visits, and coaching of a health center quality committee to use data to improve care. About 1,440 adults who have both high blood pressure and diabetes will take part. Participants will be assessed at the start of the study, at 6 months, and at 12 months. The main measure is systolic blood pressure at 12 months. The most important other measure is hemoglobin A1c (a blood test that shows average blood sugar levels over the past 2 to 3 months) at 12 months.
연구 개요
상태
상세 설명
MULTI-HEARTS is a cluster-randomized, hybrid type 2 effectiveness-implementation trial of implementation support for HEARTS, the official model for hypertension and diabetes primary care in Guatemala's Ministry of Health. Health centers in both arms will implement HEARTS through the Ministry of Health's routine strategies. In the implementation support arm, health centers also will receive additional implementation support strategies directed at health workers, managers, and support staff.
The primary objective is to evaluate whether HEARTS implementation support leads to better hypertension and diabetes control than routine HEARTS implementation among adults with hypertension and diabetes. We hypothesize that implementation support will lead to lower mean systolic blood pressure at 12 months (primary outcome) compared to routine HEARTS implementation. The key secondary outcome is mean hemoglobin A1c (HbA1c) at 12 months. Other secondary outcomes are mean diastolic blood pressure and the proportions of participants with blood pressure control, HbA1c control, and combined blood pressure and HbA1c control at 12 months. The primary implementation outcome is Reach, which is defined in the study to be the monthly number of patients treated with both antihypertensive and glucose-lowering medications at participating health centers. In an economic evaluation, we will also estimate costs, cost-effectiveness, and budget impact.
We will randomize 36 Ministry of Health health centers in a 1:1 ratio, with stratification by health area. We will enroll 1,440 adults aged 18 years or older with systolic blood pressure ≥130 mmHg and HbA1c ≥6.5%. There will be approximately 40 participants per health center and a total of 720 per arm. Allowing for 15% attrition, the trial will have at least 80% power to detect a between-arm difference of 5.0 mmHg in mean systolic blood pressure at 12 months. The health centers serve urban and rural communities, and many participants will live in poverty and have limited literacy. Some trial participants are expected to be Indigenous Maya and will primarily speak a Mayan language rather than Spanish.
After a 1-year trial planning period, health centers will be randomized before the start of the 36-month implementation period. Each participant will be followed for 12 months. Ministry of Health administrative data will also be collected for a 6-month post-trial period. In addition to the trial data, the study includes additional data collection for implementation and economic evaluations.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: David Flood, MD
- 전화번호: 734-647-2892
- 이메일: dcflood@umich.edu
연구 연락처 백업
- 이름: Peter Rohloff, MD, PhD
- 전화번호: 617-732-5500
- 이메일: prohloff@mgb.org
연구 장소
-
-
-
Guatemala City, 과테말라
- Ministry of Health health centers
-
연락하다:
- Chronic Disease Program, Ministry of Health
- 전화번호: +502 2444-7474
- 이메일: cronicas.dnpap@mspas.gob.gt
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 years or older.
- Blood pressure criteria, defined as mean systolic blood pressure of ≥130 mmHg at the screening visit and again at the enrollment visit, held 1 to 14 days apart.
- Glycemic criteria, defined as one of the following: (a) for individuals with a prior diagnosis of diabetes or currently taking a glucose-lowering drug, HbA1c of ≥6.5% at the screening visit; (b) for individuals without a prior diagnosis of diabetes and not taking a glucose-lowering drug, HbA1c of ≥6.5% at both the screening and enrollment visits.
- Living in a community served by one of the health centers included in the study and willing to receive health care at the corresponding health center.
- Provides informed consent in Spanish or the main Mayan language in the municipality where they live.
Exclusion Criteria:
- Pregnant or planning pregnancy during the 12-month follow-up period, based on self-report.
- Type 1 diabetes, based on self-reported medical history or the judgment of the study physician.
- Illness that, in the judgment of the study physician, limits life expectancy to less than 12 months or would prevent completion of study follow-up, including but not limited to end-stage kidney disease requiring or awaiting dialysis, advanced heart failure, liver failure, or cancer under active treatment.
- Currently participating in another research study involving an intervention.
- Planning to leave the community served by the health center during the 12-month follow-up period.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Implementation support arm
Routine HEARTS implementation with additional implementation support from INCAP for 36 months. |
Group refresher training every 6 months, monthly supportive supervision visits, and data-driven coaching of a health center quality committee, delivered by INCAP implementation support physicians to health workers, managers, and support staff. An initial training-of-trainers workshop, Clinical Pathways for hypertension and type 2 diabetes, and digital tools, delivered by the Ministry of Health under its National Strategy for Cardio-Reno-Metabolic Risk Management based on HEARTS. |
|
활성 비교기: Routine implementation arm
Routine HEARTS implementation alone. |
An initial training-of-trainers workshop, Clinical Pathways for hypertension and type 2 diabetes, and digital tools, delivered by the Ministry of Health under its National Strategy for Cardio-Reno-Metabolic Risk Management based on HEARTS. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Systolic blood pressure
기간: 12 months after the enrollment visit
|
Between-arm mean difference in systolic blood pressure, using the mean of 3 automated readings. |
12 months after the enrollment visit
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hemoglobin A1c
기간: 12 months after the enrollment visit
|
Key secondary outcome. Between-arm mean difference in hemoglobin A1c, measured with a point-of-care device. |
12 months after the enrollment visit
|
|
Diastolic blood pressure
기간: 12 months after the enrollment visit
|
Between-arm mean difference in diastolic blood pressure, using the mean of 3 automated readings. |
12 months after the enrollment visit
|
|
Proportion of participants with blood pressure control
기간: 12 months after the enrollment visit
|
Between-arm difference in the proportion of participants with blood pressure control of <130/<80 mmHg, as defined in national guidelines. |
12 months after the enrollment visit
|
|
Proportion of participants with hemoglobin A1c control
기간: 12 months after the enrollment visit
|
Between-arm difference in the proportion of participants with hemoglobin A1c control of <7.0%, as defined in national guidelines. |
12 months after the enrollment visit
|
|
Proportion of participants with combined blood pressure control and hemoglobin A1c control
기간: 12 months after the enrollment visit
|
Between-arm difference in the proportion of participants with combined blood pressure control (<130/<80 mmHg) and hemoglobin A1c control (<7.0%), as defined in national guidelines. |
12 months after the enrollment visit
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: David Flood, MD, MSc, University of Michigan
- 수석 연구원: Peter Rohloff, MD, PhD, Brigham and Women's Hospital
- 수석 연구원: Manuel Ramírez-Zea, MD, PhD, Institute of Nutrition of Central America and Panama
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HUM00301585
- R61HL183254 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
We will deposit de-identified participant-level data collected at study visits in a data repository selected in accordance with NHLBI policy.
IPD 공유 기간
No later than the time of an associated publication or the end of the performance period, whichever comes first.
IPD 공유 액세스 기준
The repository will control access to the data in accordance with NHLBI policy.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .