Comprehensive Patient-Centered Home-based Care Coaching for COPD Self-management

Обзор

The Icahn School of Medicine at Mount Sinai will conduct a randomized controlled trial of a self-management support intervention for predominantly minoritized and low-income adults with chronic obstructive pulmonary disease (COPD). The trial will focus on comprehensive screening and targeted management of barriers to COPD control, incorporating home-based pulmonary rehabilitation and oral steroid and antibiotic prescribing for pre-emptive treatment of COPD exacerbations. The research team will compare this intervention with an attention control group to evaluate the effects on medication adherence, COPD symptoms, inhaler technique, physical activity and exercise capacity at 6 months, and at 12 months to examine sustainability of treatment effects. The research team will also examine hospitalizations and emergency department visits at 12 months. The study will recruit 300 participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn, ensuring diverse representation. Health coaches from the VNS Health will deliver the intervention, guided by a detailed training manual. Weekly conference calls will address logistical and protocol-related issues.

Подробное описание

The Icahn School of Medicine at Mount Sinai is the lead and only site of recruitment for this project. Research study activities will be conducted at practices across the Mount Sinai Health System. The research team will identify a patient pool through the electronic health record. The research team will recruit 300 (150 per arm) participants from the Mount Sinai Health System in Manhattan, Queens, and Brooklyn in NYC. These practices provide care to a diverse population with considerable sociodemographic diversity (\~40% Latino and \~30% Black, \~50% with household incomes \<$1,350/month). Randomization will occur 1 month after the baseline interview (and after the devices are returned). Randomization will be in blocks of variable size (4 to 6) and stratified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria B or E. The study's main outcomes will be assessed at 6 months and sustainability of treatment effects at 12 months. The intervention will be delivered by community health workers (CHW)health coaches employed by VNS Health. The research team will follow a detailed intervention training manual and Manual of Operations to guide CHWs through the intervention. The CHWs will also attend a 90-minute monthly group meeting to discuss cases and hear presentations on topics of their choosing for skills and knowledge development. The research team will meet by conference call weekly to discuss logistical issues, refinement of protocol, and other issues pertaining to the study. The project manager will email any modifications to the IRB and research coordinator within one day of receiving approval. The project manager will also email a copy of the amendment approval letter. Mount Sinai will abide by IRB policies as serving site.

Вмешательства

• Поведенческое Self-Management Support
  The intervention will be delivered by CHWs in person and supplemented with telephone or video encounters over 6 months. The intervention comprises six core elements: engagement, intake, self-management assessment, barrier screening, actions to address identified barriers, and follow-up/maintenance support.
• Поведенческое COPD Education
  The attention control is where CHWs will provide COPD education using the COPD 1-2-3 booklet. The attention control will consist of 6 CHW visits (approximately 1 per month) with the patient and care giver in their home or via video conference, per patient preference.

Первичные конечные точки

• COPD Assessment Test (CAT) Score [Срок оценки: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period]
• Number of participants who adhere to ≥ 80% of prescribed actuations [Срок оценки: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period]

Вторичные конечные точки (6)

• Inhaler Technique [Срок оценки: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period]
• Number of steps counted on Actigraph [Срок оценки: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period]
• Quality of life measured using the Clinical COPD Questionnaire (CCQ) [Срок оценки: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period]
• Number of participants with hospitalizations [Срок оценки: at Baseline and at 12 months]
• Number of participants with emergency department (ED) visits [Срок оценки: at Baseline and at 12 months]
• Six Minute Walk Test (6MWT) to measure Exercise Capacity [Срок оценки: at baseline, end of treatment period (each treatment period are 90-minute monthly treatments over 6 months), and 6 months after end of treatment period]

Критерии участия

Критерии включения

• Age ≥40 years
• Chart-documented COPD with GOLD classifications B or E based on CAT score and number of exacerbations with or without hospitalization determined by electronic health record (EHR) review. GOLD class B and E patients are at increased risk of activity limiting symptoms and exacerbation and are more likely to benefit from the intensive SAMBA-COPD intervention.
• Prescribed a long-acting muscarinic agonist (LAMA), long-acting beta-adrenergic receptor agonist (LABA), an inhaled corticosteroid (ICS), or any combination of these since much of the intervention's focus is on medication adherence.
• English or Spanish speaking

Критерии исключения

• EHR documented dementia, as the research teams focus is on patients with capacity to independently perform self-care tasks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ichan School of Medicine at Mount Sinai — New York

Публикации

• Agrawal N, Case M, Lindenauer PK, McDermott D, Diaz KM, Utkin JO, Wisnivesky J, Federman A. Protocol for a randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches. Contemp Clin Trials. 2025 Nov;158:108095. doi: 10.1016/j.cct.2025.108095. Epub 2025 Sep 22. PMID 40992542

Идентификаторы

NCT: NCT06634810 · STUDY-23-00838 · R01HL171695 · GCO-23-0270

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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