Heart-Kidney-Diabetes Multidisciplinary Care MOdels for CardiovascuLar Health In Patients With Chronic Kidney DiSease and Diabetes: A PragmaTIC Cluster Randomized Controlled Trial (HOLISTIC) (HOLISTIC)
2026년 9월 3일 업데이트: Baim Institute for Clinical Research
Our overarching goal of this study is to provide rigorous evidence for using an accelerated risk-based approach to implementing guideline directed medical therapies (GDMT) using a multidisciplinary care model (MCM) versus a usual care model (UCM) to improve a composite GDMT score, reduce kidney disease and heart failure (HF) events, hospitalizations, and total healthcare costs for patients with type 2 diabetes (T2D) and CKD with high- to very-high Kidney Disease: Improving Global Outcomes (KDIGO) risk.
연구 개요
상태
아직 모집하지 않음
상세 설명
The study is designed to provide evidence for MCM versus UCM to improve a composite GDMT score, reduce major kidney and cardiovascular risks, reduce hospitalizations (and thereby healthcare costs), and improve QoL, for patients with T2D and high and very high KDIGO CKD risk.
These Specific Aims address critical gaps including lack of patient access to subspecialists, PCC and patient inertia, and inadequate infrastructure to optimize nutrition.
The MCM is designed to increase GDMT uptake across the health system, PCC, and patient domains.
Outside the US, MCMs in patients with CKD and T2D have shown promise by reducing CKM risk factors, healthcare costs, subspecialty clinic visits, and hospitalizations.
Given lack of patient access to subspecialists in the US,32 especially nephrologists, a specialist-dominant model for GDMT uptake and optimization may not be feasible in many health systems.
Notably, PCCs are also in shortage by workforce capacity, and they have large patient panels, severe time constraints, and competing priorities.
Therefore, maintaining vital PCC and patient relationships, while bringing a primary-care-based CKM pharmacist onboard with consulting subspecialists, is a way forward.
HOLISTIC will answer a call for research on team-based primary care to alleviate physician shortages for under-served health needs such as T2D and CKD.
This approach can also capitalize on successes pioneered by telehealth during the COVID-19 pandemic for complex chronic conditions by assisting PCCs through pharmacist led CMM.
Finally, it allows a strategic re-purposing of existing resources (pharmacist clinicians) who can support PCCs and lead CMM and GDMT deployment in a risk-appropriate and timely fashion, to demonstrate value to this alternate model across optimal care delivery, clinical outcomes, cost savings/return on investment.
연구 유형
중재적
등록 (추정된)
570
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: C. Michael Gibson, MS, MD Chief Executive Officer, MS, MD
- 전화번호: 617-307-5200
- 이메일: info@baiminstitute.org
연구 연락처 백업
- 이름: Patricia Wedge M Chief Operating Officer, RN, BSN, CCRC
- 전화번호: 617-307-5320
- 이메일: patricia.wedge@baiminstitute.org
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Provide written informed consent
- Adults ≥18 years of age with T2D and CKD at high or very high KDIGO risk (Figure A1): eGFR 45-59 mL/min/1.73 m2 and UACR >300 mg/g OR eGFR 30-44 mL/min/1.73 m2 and UACR >30 mg/g OR any eGFR <30 mL/min/1.73 m2.
Exclusion Criteria:
- Advanced HF on inotrope support or requiring left ventricular assist device support.
- Chronic hemodialysis or peritoneal dialysis or kidney transplant
- Life expectancy of <1-year, and vulnerable populations such as pregnant women, incarcerated individuals, or those with active psychiatric illness.
- Unreliable or non-compliant, including patients with known history of alcoholism, drug abuse, or serious psychiatric disorder; as well as patients unwilling to abide by the requirements of the protocol
- Any condition that would interfere with the patient's ability to comply with study instructions, might confound the interpretation of the study, or put the patient at risk
- Personnel, or any relative of personnel, of the Sponsor, the CRO, or the investigative site(s)
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 |
|---|---|
|
활성 비교기: multidisciplinary care model (MCM) intervention
This model/arm will include Primary Care Clinician (PCC) delivered care assisted by a Multidisciplinary Heart-Kidney-Diabetes Care Team Model (MCM)
|
The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
|
|
간섭 없음: a usual care model (UCM)
This model/arm will include PCC delivered care with as-needed Local Specialist Support, representing the Usual Care Model (UCM)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score
기간: Baseline to 12 months
|
Composite GDMT calculated from baseline to Month 12 across five pre-defined medication classes (RAS inhibitors, SGLT2 inhibitors, GLP-1 receptor antagonists, non-steroidal mineralocorticoid receptor antagonists, and statins).
The score is the sum of baseline use and changes during follow-up (+1 for initiation of a medication class and -1 for discontinuation).
This represents a single composite outcome.
|
Baseline to 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of participants with all-cause mortality
기간: 12 Months
|
Number of participants who die from any cause during the 12-month follow-up.
|
12 Months
|
|
Outcome Measure: Number of Participants with Worsening Kidney Disease
기간: 12 Months
|
Number of participants experiencing worsening kidney disease, defined according to the study protocol as ≥40% decline in estimated glomerular filtration rate (eGFR) from enrollment, eGFR <10 mL/min/1.73
m², initiation of dialysis, or kidney transplantation.
|
12 Months
|
|
Outcome Measure: Number of Participants with Worsening Heart Failure Events
기간: 12 Months
|
Number of participants experiencing worsening heart failure, including heart failure hospitalization or urgent heart failure visit.
|
12 Months
|
|
Outcome Measure: Major Adverse Cardiovascular Events (MACE)
기간: 12 Months
|
Number of participants experiencing major adverse cardiovascular events, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
|
12 Months
|
|
Outcome Measure: Change from Baseline in Kidney Disease Quality of Life (KDQOL-36) Summary Score
기간: Baseline and 12 Months
|
Mean change from baseline to Month 12 in the Kidney Disease Quality of Life (KDQOL-36) summary score.
Unit of Measure: Points
|
Baseline and 12 Months
|
|
Change in PREVENT-CVD Predicted Cardiovascular Risk Score
기간: 12 Months
|
Change from baseline to 12 months in predicted cardiovascular risk estimated using the PREVENT-CVD risk calculator among participants without established cardiovascular disease at baseline. Unit of Measure: Percentage points (%) |
12 Months
|
|
eGFR Total Slope
기간: 12 Months
|
Annualized rate of change in estimated glomerular filtration rate (eGFR) from baseline through 12 months. Unit of Measure: mL/min/1.73 m²/year |
12 Months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety Outcome Measure 1: Number of participants with acute kidney injury
기간: 12 Months
|
Acute kidney injury defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or an increase in serum creatinine to ≥1.5 times baseline within 7 days. Unit of Measure: Participants with event |
12 Months
|
|
Safety Outcome Measure 2: Number of participants with hypotension
기간: 12 Months
|
Hypotension defined as systolic blood pressure <90 mmHg or symptomatic hypotension requiring clinical intervention, medication adjustment, or study drug discontinuation. Unit of Measure: Participants with event |
12 Months
|
|
Safety Outcome Measure: Number of participants with volume depletion
기간: 12 Months
|
Volume depletion defined as clinical evidence of dehydration or hypovolemia requiring fluid replacement, medication adjustment, emergency department evaluation, or hospitalization. Unit of Measure: Participants with event |
12 Months
|
|
Safety Outcome Measure Title: Number of participants with hyperkalemia
기간: 12 Months
|
Hyperkalemia defined as clinically significant elevation in serum potassium requiring clinical intervention, medication adjustment, emergency department evaluation, or hospitalization, according to the study protocol. Unit of Measure: Participants with event |
12 Months
|
|
Safety Outcome Measure: Number of participants with hypoglycemia
기간: 12 Months
|
Hypoglycemia defined according to American Diabetes Association (ADA) Standards of Care as blood glucose <70 mg/dL (Level 1 hypoglycemia). Severe hypoglycemia is defined as an event requiring assistance from another person. Unit of Measure: Participants with event |
12 Months
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (추정된)
2026년 12월 1일
기본 완료 (추정된)
2029년 5월 1일
연구 완료 (추정된)
2029년 5월 1일
연구 등록 날짜
최초 제출
2026년 6월 5일
QC 기준을 충족하는 최초 제출
2026년 9월 3일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 3일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BICR 2026-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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