Medication Adherence in Patients With Sarcoidosis (MAPS)

December 9, 2025 updated by: Johns Hopkins University

Medication Adherence and Clinical Outcomes in Sarcoidosis

The goal of the study is to look at the relationship between how individuals with Sarcoidosis take the sarcoidosis medicines and how it affects the disease, to evaluate any factors that may make individuals not want to take the medicines, and to develop and refine ways to help support individuals with Sarcoidosis especially when it comes to the medicines. The overall hypothesis is higher medication adherence will be associated with better clinical outcomes in sarcoidosis. The investigators will enroll 150 patients with biopsy proven pulmonary sarcoidosis for at least one year who are on any oral treatment regimen for at least six months into a 12-month longitudinal study.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Asthma and Allergy Center
      • Timonium, Maryland, United States, 21093
        • Johns Hopkins Greenspring Station

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of individuals with Sarcoidosis who are seen at the Johns Hopkins Sarcoidosis clinic.

Description

Inclusion Criteria:

  • At least 18 years of age.
  • Physician diagnosis of Sarcoidosis.
  • Biopsy proven pulmonary involvement of Sarcoidosis.
  • On oral Sarcoidosis medications for at least 6 months.
  • Permanently reside in Maryland or D.C.
  • Fully vaccinated against COVID-19.

Exclusion Criteria:

  • Non-english speaking.
  • Unable to provide consent.
  • Unable to participate in orally administered questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in King's Sarcoidosis Health Questionnaire (KSQ) score
Time Frame: Baseline, 6 months and 12 months
The KSQ is a 29-item validated measure of sarcoidosis health status. Scores range from 0 to 100. Higher KSQ scores are better. Lower KSQ scores are worse.
Baseline, 6 months and 12 months
Change in St. George's Respiratory Questionnaire (SGRQ) score
Time Frame: Baseline, 6 months and 12 months
The SGRQ is an instrument that contains 50 items in three subscales (symptoms, activity, and impact). Scores range from 100 to 0. Lower scores for the SGRQ are better and higher scores are worse.
Baseline, 6 months and 12 months
Change in Forced Expiratory Volume (FEV1) as assessed by Pulmonary Function Testing
Time Frame: Baseline, 6 months and 12 months
Forced Expiratory Volume (FEV1) will be collected by performing Pulmonary Function Testing using spirometry. FEV1 is the maximum amount of air that can be forcibly exhaled in one second.
Baseline, 6 months and 12 months
Change in Forced Vital Capacity (FVC) as assessed by Pulmonary Function Testing
Time Frame: Baseline, 6 months and 12 months
Forced Vital Capacity (FVC) will be collected by performing Pulmonary Function Testing using spirometry. FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.
Baseline, 6 months and 12 months
Change in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) as assessed by Pulmonary Function Testing
Time Frame: Baseline, 6 months and 12 months
Diffusing Capacity of Lung for Carbon Monoxide (DLCO) is a measure of the efficiency of lung gas transfer. DLCO will be collected by performing Pulmonary Function Testing after performing spirometry.
Baseline, 6 months and 12 months
Change in 6-minute walk distance
Time Frame: Baseline, 6 months and 12 months
The distance (in meters) a participant is able to walk in 6 minutes will be assessed.
Baseline, 6 months and 12 months
Change in Modified Medical Research Council Dyspnea Scale (MRC) score
Time Frame: Baseline, 6 months and 12 months
MRC is a simple scale that has been validated as a method of categorizing patients in terms of their disability attributable to dyspnea. The scale has 5 items on it. Scores range from 0 to 4. Higher scores are worse and lower scores are better.
Baseline, 6 months and 12 months
Change in Health Care Utilization (HCU) as assessed by the CRISP Database
Time Frame: 12 months prior to enrollment and the duration of the study for a total of 24 months
Health Care Utilization (HCU) for 12 months prior to enrollment and the duration of the study for a total of 24 months will be obtained through the Chesapeake Regional Information System for our Patients (CRISP) database. With consent, researchers are able to receive real-time notifications whenever a participant receives care at any of the hospitals or long-term care facilities. Data available on participants includes records from hospitalizations such as discharge summaries, diagnosis, imaging, and laboratory values. Hospitalization and emergency department (ED) utilization will be coded as a yes/no event. We will also collect self-report hospitalizations and ED visits from the participants at each study visit.
12 months prior to enrollment and the duration of the study for a total of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Michelle Sharp, MD, MHS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 24, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00299921
  • 1K23HL148527-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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