Feasibility Pilot Trial of Med Management in COPD

NCT07453719 | Not Yet Recruiting

• 2 other identifiers: Pro00118496K23HL159239
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

A pilot trial to examine feasibility of a pharmacist-led intervention for patients with COPD (Chronic Obstructive Pulmonary Disease) and multimorbidity to improve medication safety and reduce dyspnea. Patients will receive inhaler teaching and medication optimization counseling. Outcomes include feasibility, acceptability, appropriateness, and exploratory measures such as medication discontinuation and patient-reported symptom burden.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Medication Management; Deprescribing

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible patients recruited to the intervention

  A measure of feasibility of the intervention.

  Through the end of enrollment period, up to approximately 1 year

Secondary Outcomes (6)

• Acceptability of Intervention Measure (AIM)

  Baseline, 4 weeks, 12 weeks

• Feasibility of Intervention Measure (FIM)

  Baseline, 4 weeks, 12 weeks

• Intervention Appropriateness Measure (IAM)

  Baseline, 4 weeks, 12 weeks

• Modified Medical Research Council (mMRC) questionnaire to measure dyspnea

  Baseline, 4 weeks, 12 weeks

• Medication side effect burden, measured via Living with Medicines Questionnaire (LMQ-3)

  Baseline, 4 weeks, 12 weeks

Other Outcomes (2)

• Number of participants with Fall Risk-Increasing Drug (FRID) discontinuation per patient report

  At week 4

• Perceptions of the intervention via qualitative interviews

  At week 12

Study Arms (1)

Pharmacist-led Medication Management

EXPERIMENTAL

Pharmacist visit for inhaler teaching and medication optimization with follow-up at weeks 4 and 12.

Behavioral: Pharmacist-led Medication Management Intervention

Interventions

Pharmacist-led Medication Management Intervention BEHAVIORAL

In-clinic or telehealth pharmacist visit for inhaler teaching, medication optimization, and deprescribing counseling; includes follow-up at weeks 4 and 12.

Pharmacist-led Medication Management

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45
• Diagnosis of COPD
• Medicare/Medicaid insured
• Using an inhaler
• Reports dyspnea or suboptimal medication adherence

You may not qualify if:

• Under age 18 (caregivers/clinicians)
• Under age 45 (patients)
• Opioid use disorder
• Cognitive impairment
• Unable to communicate in English

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Duke University: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cara McDermott

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Hecker, MSN, RN

CONTACT

(919) 660-6612; emily.hecker@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share