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

Study acronym: SAMBA COPD
StatusRecruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Jan 31, 2027 → Jun 1, 2027
See other at-risk trials from Icahn School of Medicine at Mount Sinai

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 31, 2027 to Jun 1, 2027 Show 6 more changesShow less
    • Study completion pushed from Jan 31, 2027 to Jan 31, 2028
    • Start date: Sep 25, 2024 to Sep 1, 2024
    • Secondary endpoints: details revised at 2 of 6 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 5 words
  2. Primary and study completion dates: Apr 1, 2028 to Jan 31, 2027v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06634810
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Baystate Medical Center, VNS Health, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Chronic Obstructive Pulmonary Disease
Related terms Pulmonary Disease, Chronic Obstructive
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov