Clinical trial NCT05438095: Medication Adherence in Patients With Sarcoidosis
Official title: Medication Adherence and Clinical Outcomes in Sarcoidosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medication Adherence
Sarcoidosis
Keywords: Sarcoidosis
Adherence
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-06-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in King's Sarcoidosis Health Questionnaire (KSQ) score
timeFrame: Baseline, 6 months and 12 months
measure: Change in St. George's Respiratory Questionnaire (SGRQ) score
timeFrame: Baseline, 6 months and 12 months
measure: Change in Forced Expiratory Volume (FEV1) as assessed by Pulmonary Function Testing
timeFrame: Baseline, 6 months and 12 months
measure: Change in Forced Vital Capacity (FVC) as assessed by Pulmonary Function Testing
timeFrame: Baseline, 6 months and 12 months
measure: Change in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) as assessed by Pulmonary Function Testing
timeFrame: Baseline, 6 months and 12 months
measure: Change in 6-minute walk distance
timeFrame: Baseline, 6 months and 12 months
measure: Change in Modified Medical Research Council Dyspnea Scale (MRC) score
timeFrame: Baseline, 6 months and 12 months
measure: Change in Health Care Utilization (HCU) as assessed by the CRISP Database
timeFrame: 12 months prior to enrollment and the duration of the study for a total of 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Asthma and Allergy Center
state: Maryland
city: Timonium
country: United States
facility: Johns Hopkins Greenspring Station
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michelle Sharp, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: