Medication Adherence and Clinical Outcomes in Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in St. George's Respiratory Questionnaire (SGRQ) score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Non-english speaking.
- •Unable to provide consent.
- •Unable to participate in orally administered questionnaires.
结局指标
主要结局
Change in St. George's Respiratory Questionnaire (SGRQ) score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点