CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 59 enrolled
Drug / intervention
Self-management barrier support +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04533412
NCT04533412N/ACompleted

Comprehensive Home-based Self-management Support for COPD Patients

Icahn School of Medicine at Mount Sinai·interventional·Posted Aug 31, 2020·Updated Sep 28, 2023

In Brief

A clinical study evaluating Self-management barrier support and Basic COPD Education for COPD and Self-management Behaviors. Completed, enrolled 59 participants across 1 site.

Detailed Summary

The study team will adapt and expand an effective model of asthma self-management support for patients with chronic obstructive pulmonary disease (COPD). In this new model, community health workers will comprehensively screen for and address barriers to effective COPD self-management, including maladaptive coping behaviors, and guide patients through home-based pulmonary rehabilitation. Feasibility of the new model will be assessed in preparation for a fully powered, multisite randomized trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 31, 2020
Enrollment StartAug 24, 2020
Primary CompletionApr 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.8 years ago

Interventions

Self-management barrier supportbehavioral

For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.

Basic COPD Educationbehavioral

The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to "check in" with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician.