RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-25
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06634810

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥40 years
  2. * 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.
  3. * 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.
  4. * English or Spanish speaking
  1. * EHR documented dementia, as the research teams focus is on patients with capacity to independently perform self-care tasks.

Contacts and Locations

Study Contact

Alex Federman, MD, MPH
CONTACT
212-824-7565
alex.federman@mountsinai.org
Ruchir Goswami, MBBS, MPH
CONTACT
212-824-7449
ruchir.goswami2@mountsinai.org

Principal Investigator

Alex Federman, MD, MPH
PRINCIPAL_INVESTIGATOR
Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital

Study Locations (Sites)

Ichan School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Alex Federman, MD, MPH, PRINCIPAL_INVESTIGATOR, Ichan School of Medicine at Mount Sinai, The Mount Sinai Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-25
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2024-09-25
Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

  • COPD
  • Home Based
  • Self Management
  • Pulmonary Rehabilitation
  • Coaching

Additional Relevant MeSH Terms

  • Chronic Obstructive Pulmonary Disease