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NCT Number: NCT07453719

Feasibility Pilot Trial of Med Management in COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of eligible patients recruited to the intervention

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

    A measure of feasibility of the intervention.

Secondary outcomes

  1. Acceptability of Intervention Measure (AIM)

    Time frame: Baseline, 4 weeks, 12 weeks

    The AIM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater acceptability.

  2. Feasibility of Intervention Measure (FIM)

    Time frame: Baseline, 4 weeks, 12 weeks

    The FIM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater feasibility.

  3. Intervention Appropriateness Measure (IAM)

    Time frame: Baseline, 4 weeks, 12 weeks

    The IAM is comprised of 4 items rated on a 5-point Likert scale, where the total score ranges from 4 to 20. A higher score indicates greater appropriateness.

  4. Modified Medical Research Council (mMRC) questionnaire to measure dyspnea

    Time frame: Baseline, 4 weeks, 12 weeks

    The mMRC dyspnea scale is a 5-grade (0 to 4) questionnaire that measures the severity of breathlessness in daily activities, commonly used for assessing functional disability in COPD and other respiratory diseases. A higher score indicates greater, more incapacitating breathlessness.

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

    Time frame: Baseline, 4 weeks, 12 weeks

    Medication side effect burden refers to the physical, emotional, and practical impact of adverse drug reactions, often causing reduced quality of life, non-adherence, and treatment discontinuation.

  6. Shared Decision Making (SDM-Q-9) questionnaires

    Time frame: Baseline, 4 weeks, 12 weeks

    The SDM-Q-9 has a total score range of 0 to 45, where a higher score indicates greater shared decision-making between patients and providers.

Other outcomes

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

    Time frame: At week 4

    FRIDs are medications that heighten the risk of falls in older adults by causing dizziness, sedation, or impaired balance.

  2. Perceptions of the intervention via qualitative interviews

    Time frame: At week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Hecker, MSN, RN

CONTACT

[email protected]

(919) 660-6612

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Feasibility Pilot Trial of a Pharmacist-led Medication Management Intervention for Multi-Morbid Adults With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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