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)
2026年9月3日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
570
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：C. Michael Gibson, MS, MD Chief Executive Officer, MS, MD
- 電話番号：617-307-5200
- メール：info@baiminstitute.org
研究連絡先のバックアップ
- 名前：Patricia Wedge M Chief Operating Officer, RN, BSN, CCRC
- 電話番号：617-307-5320
- メール：patricia.wedge@baiminstitute.org
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
介入なし：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)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with all-cause mortality
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety Outcome Measure 1: Number of participants with acute kidney injury
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年12月1日
一次修了 (推定)
2029年5月1日
研究の完了 (推定)
2029年5月1日
試験登録日
最初に提出
2026年6月5日
QC基準を満たした最初の提出物
2026年9月3日
最初の投稿 (実際)
2026年9月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月10日
QC基準を満たした最後の更新が送信されました
2026年9月3日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BICR 2026-02
個々の参加者データ (IPD) の計画
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いいえ
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いいえ
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