Medication Adherence in Patients With Sarcoidosis

NCT05438095 | Active Not Recruiting

• 2 other identifiers: IRB002999211K23HL148527-01A1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Medication Adherence; Sarcoidosis

Keywords

Sarcoidosis; Adherence

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Bayview Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Greenspring Station

Timonium, Maryland, 21093, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collecting blood: Complete Blood Count (CBC) with differential. Will also be collecting Peripheral Blood Mononuclear Cells (PBMCs) and some genetic material will be obtained through these PBMCs.

MeSH Terms

Conditions

Medication Adherence; Sarcoidosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Michelle Sharp, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: May 11, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

US (2)