N/A N=59 Randomized Double-blind Supportive Care

Comprehensive Self-management Support for COPD Patients

COPD · Self-management Behaviors

Bottom Line

View on ClinicalTrials.gov: NCT04533412 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2023

Primary outcome: Primary: COPD Assessment Test (CAT) — 22.0; 21.9; 21.5; 22.7 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Self-management barrier support (Behavioral); Basic COPD Education (Behavioral)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY COPD Assessment Test (CAT)	22.0; 21.9; 21.5; 22.7	—
SECONDARY Number of Participants With Medication Adherence Report Scale (MARS) Score ≥4.5	13; 13; 14; 10	—
SECONDARY Exercise Tolerance - 6 Minute Walk Test	244.3; 288.3; 266.9; 291.0	—
SECONDARY Physical Activity Adult Questionnaire (PAAQ)	214; 231; 262; 234	—
SECONDARY Number of Participants With Hospitalizations	15; 14; 10; 12	—
SECONDARY Number of Participants With ED Visits	15; 19; 13; 13	—
SECONDARY Number of Participants With Controller Medication Adherence	3; 3; 5; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Age >40 years
Chart-document severe or very severe COPD (FEV1<50% predicted) or COPD-related ED/hospitalization ≥ 1 visit within the past 12 months
Prescribed any daily medication for COPD, English or Spanish speaking, Smoking history ≥ 10 pack-years

Exclusion Criteria

Diagnosis in the clinical record of dementia, because the study focuses on patients with capacity to independently perform self-management tasks.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04533412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.