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Active, Not Recruiting

NCT Number: NCT05438095

Medication Adherence in Patients With 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Medication Adherence Behavior Health Behavior Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Patient Acceptance of Health Care Patient Compliance Sarcoidosis Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Bayview Asthma and Allergy Center, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Medication Adherence and Clinical Outcomes in Sarcoidosis

Acronym: MAPS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2022
Registry last updated
Dec 11, 2025

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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