Medication AdherenceMAPSNCT05438095
Medication Adherence in Patients With Sarcoidosis
An observational study of Medication Adherence and Sarcoidosis, run by Johns Hopkins University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Sarcoidosis
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 May 2022to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals with Sarcoidosis who are seen at the Johns Hopkins Sarcoidosis clinic.
Who may be able to join
- 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.
Who cannot join
- Non-english speaking.
- Unable to provide consent.
- Unable to participate in orally administered questionnaires.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Asthma and Allergy Center
Baltimore, Maryland, 21224
Johns Hopkins Greenspring Station
Timonium, Maryland, 21093
About this study
Official title: Medication Adherence and Clinical Outcomes in Sarcoidosis
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
- Medical subject headings
- Medication Adherence, Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months prior to enrollment and the duration of the study for a total of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start11 May 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michelle Sharp, MD, MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438095
- Sponsor's protocol ID
- IRB00299921
- Other IDs
- 1K23HL148527-01A1
- Acronym
- MAPS
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Adherence and Clinical Outcomes in Sarcoidosis
- ClinicalTrials.gov ID
- NCT05438095
- Acronym / sponsor ID
- MAPS / IRB00299921
- Conditions
- Medication Adherence, Sarcoidosis
- Keywords
- Sarcoidosis, Adherence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals with Sarcoidosis who are seen at the Johns Hopkins Sarcoidosis clinic.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Non-english speaking.
- Unable to provide consent.
- Unable to participate in orally administered questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in King's Sarcoidosis Health Questionnaire (KSQ) score
Time frame: 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 St. George's Respiratory Questionnaire (SGRQ) score
Time frame: 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 Forced Expiratory Volume (FEV1) as assessed by Pulmonary Function Testing
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Related trials for Medication Adherence
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Active, not recruiting
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
Depression
Not yet recruiting
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
Not yet recruiting
Personalized Routine and Habit Integration to Support Medication Management
Medication Adherence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Sharp, MD, MHS principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence and Sarcoidosis, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in King's Sarcoidosis Health Questionnaire (KSQ) score (time frame: Baseline, 6 months and 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.