Medication Adherence in Patients With Sarcoidosis

Recruiting

• Conditions: Medication Adherence; Sarcoidosis

• Registration Number: NCT05438095
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-11
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in St. George's Respiratory Questionnaire (SGRQ) score	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.
Change in King's Sarcoidosis Health Questionnaire (KSQ) score	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.
Change in Forced Expiratory Volume (FEV1) as assessed by Pulmonary Function Testing	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.
Change in Forced Vital Capacity (FVC) as assessed by Pulmonary Function Testing	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.
Change in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) as assessed by Pulmonary Function Testing	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.
Change in 6-minute walk distance	Baseline, 6 months and 12 months	The distance (in meters) a participant is able to walk in 6 minutes will be assessed.
Change in Modified Medical Research Council Dyspnea Scale (MRC) score	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.
Change in Health Care Utilization (HCU) as assessed by the CRISP Database	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.

Trial Locations

Locations (2)

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

Johns Hopkins Greenspring Station; 🇺🇸 Timonium, Maryland, United States