Medication Adherence in Patients With Sarcoidosis

Medication Adherence Clinical Trial

— MAPS  

Official title:

Medication Adherence and Clinical Outcomes in Sarcoidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05438095
• Other study ID #: IRB00299921
• Secondary ID: 1K23HL148527-01A
• Status: Recruiting
• Start date: May 11, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Michelle Sharp, MD, MHS
• Phone: 410-550-7753
• Email: msharp5[@]jhmi.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medication Adherence
• Sarcoidosis

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Asthma and Allergy Center	Baltimore	Maryland
United States	Johns Hopkins Greenspring Station	Timonium	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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