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Not yet recruiting NCT07453719

Feasibility Pilot Trial of Med Management in COPD

No phase Interventional Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacist-led Medication Management Intervention.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Pharmacist-led Medication Management Intervention
    In-clinic or telehealth pharmacist visit for inhaler teaching, medication optimization, and deprescribing counseling; includes follow-up at weeks 4 and 12.

Primary outcome measures

  • Proportion of eligible patients recruited to the intervention [Time frame: Through the end of enrollment period, up to approximately 1 year]
Secondary outcome measures (6)
  • Acceptability of Intervention Measure (AIM) [Time frame: Baseline, 4 weeks, 12 weeks]
  • Feasibility of Intervention Measure (FIM) [Time frame: Baseline, 4 weeks, 12 weeks]
  • Intervention Appropriateness Measure (IAM) [Time frame: Baseline, 4 weeks, 12 weeks]
  • Modified Medical Research Council (mMRC) questionnaire to measure dyspnea [Time frame: Baseline, 4 weeks, 12 weeks]
  • Medication side effect burden, measured via Living with Medicines Questionnaire (LMQ-3) [Time frame: Baseline, 4 weeks, 12 weeks]
  • Shared Decision Making (SDM-Q-9) questionnaires [Time frame: Baseline, 4 weeks, 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07453719 · Pro00118496 · K23HL159239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗