Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Home Based, Self Management, Pulmonary Rehabilitation, Coaching
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSelf-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.
BEHAVIORALCOPD 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.
Sponsors
Baystate Medical Center
VNS Health
National Heart, Lung, and Blood Institute (NHLBI)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Research Coordinators conducting interviews, and all investigators will be blinded to treatment allocation.
Intervention model description
This project will conduct a randomized controlled trial to evaluate a self-management support intervention for predominantly minoritized, low-income adults with COPD.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* EHR documented dementia, as the research teams focus is on patients with capacity to independently perform self-care tasks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COPD Assessment Test (CAT) Score | 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 | The COPD Assessment Test (CAT) is a validated measure of the impact of COPD on a person's life. COPD symptoms will be measured by self-report using the CAT. Full range from 0-40, with higher scores indicating a more severe impact of COPD on a patient's life. |
| Number of participants who adhere to ≥ 80% of prescribed actuations | 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 | Adherence will be measured by the number of participants who adhere to ≥ 80% of prescribed actuations (doses). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measured using the Clinical COPD Questionnaire (CCQ) | 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 | The CCQ is a 10-item questionnaire scored from 0 to 6 for each item (0 being never and 6 being all the time, with higher scores representing worse quality of life). The total score is 0-60. |
| Inhaler Technique | 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 | Participants will be observed performing an inhalation from their COPD controller medication. Participant inhaler technique will be scored using a validated checklist. Higher score indicates better health outcomes. For metered dose and dry powdered inhalers, 0-7 For Ellipta devices, 0-9 For Respimat devices, 0-12 |
| Number of participants with hospitalizations | at Baseline and at 12 months | Number of participants with hospitalizations for COPD-related events obtained from the Statewide Planning and Research Cooperative System (SPARCS). |
| Six Minute Walk Test (6MWT) to measure Exercise Capacity | 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 | The 6MWT measures the total the distance walked by the participant over 6 minutes on a closed track. |
| Number of steps counted on Actigraph | 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 | Physical activity will be measured by total number of steps counted on triaxial accelerometer (Actigraph). |
| Number of participants with emergency department (ED) visits | at Baseline and at 12 months | Number of participants with ED visits obtained from the Statewide Planning and Research Cooperative System (SPARCS). |
Countries
United States
Contacts
Primary ContactAlex Federman, MD, MPH
Backup ContactJennifer Utkin, MS
Outcome results
None listed